Patient SafetyNCT06711484
Evaluation of the Efficiency of a Training Program Developed For Newly Graduate Nurses
A study testing Speak up traning program in people with Patient Safety and Nurse Training, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: This research is a randomized, pre-test post-test control group, parallel group experimental study to evaluate the effectiveness of the language training program developed for newly graduated nurses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Nurse Training, Communication
- What is being tested?
- Speak up traning program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a maximum of two years of post-graduation professional experience
- Having a minimum of three months of post-graduation professional experience
- Being willing to participate in the research
- Having completed general orientation training
Who cannot join
- Having received previous training in language translation
- Those with education below undergraduate level
- Not having attended the entire training program
- Not having completed all the data collection tools
- Wanting to leave the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Nursing Faculty
Ankara, Ankara, 06500
About this study
Official title: Evaluation of The Effıciency Of Speaking Up Training Program Developed For Newly Graduate Nurses
Brief Summary: This research is a randomized, pre-test post-test control group, parallel group experimental study to evaluate the effectiveness of the language training program developed for newly graduated nurses. The study will be conducted with a total of 76 newly graduated nurses, 38 in the experimental group and 38 in the control group, at Etlik City Hospital Orthopedics-Neurology Hospital in Ankara. Participants will be informed about the study at the beginning of the study. Participants who agree to participate in the study and meet the eligibility criteria will be randomly assigned to groups by an independent statistician. The language training program will be applied to the experimental group, while no intervention will be made to the control group. The training program to be given to the experimental group will consist of a total of two days and four sessions (communication, speaking, patient safety, medical error), and each session will last 90 minutes. Data collection forms will be applied to the experimental and control groups before and after the training. Data collection forms include the descriptive characteristics form, working voice scale, effective communication skills scale, attitude scale in medical errors, and feedback about the language training program. Blinding of the raters will be applied to the participants to minimize bias. Data analysis will use statistical software that uses parametric tests for normally distributed data and nonparametric tests for non-normally distributed data.
Read the detailed description
Purpose of the Study
The purpose of the study is to evaluate the effectiveness of the speak-up training program developed for newly graduated nurses.
Hypotheses of the Study H0-1: The speak-up training program has no effect on the employee voice levels of newly graduated nurses.
H1-1: The speak-up training program has an effect on the employee voice levels of newly graduated nurses.
H0-2: The speak-up training program has no effect on the effective communication skill levels of newly graduated nurses.
H1-2: The speak-up training program has an effect on the effective communication skill levels of newly graduated nurses.
H0-3: The speak-up training program has no effect on the medical error attitude levels of newly graduated nurses.
H1-3: The speak-up training program has an effect on the medical error attitude levels of newly graduated nurses.
Variables of the Study
Independent variables
- Socio-demographic characteristics of the new graduate nurses
Dependent variables
- Total score of the Employee Voice scale after the implementation of the training program developed for the speaking up of new graduate nurses
- Total and sub-dimension scores of the Communication Skills scale after the implementation of the training program developed for the speaking up of new graduate nurses Total and sub-dimension scores of the Attitude to Medical Errors scale after the implementation of the training program developed for the speaking up of new graduate nurses
- Evaluations of the training program developed for the lspeaking up of new graduate nurses
Population and Sample of the Study
The population of the study will consist of 152 newly graduated nurses working at Etlik City Hospital Campus Orthopedics-Neurology Hospital. The characteristics of the newly graduated nurses selected for this study are that they have completed basic nursing professional education, have been in the clinic for the first two years after graduation, and have not received speaking up training. The sample size of the study was determined by power analysis (G*Power 3.1 program). In a similar study in the relevant literature, in the study conducted by Walther et al. (2022), the effect size for the difference in vocalization between the groups (Effect size) was 0.811. In order to exceed the 95% value in determining the power of the study; 68 people, 34 in the groups, should be reached at a significance level of 5% and an effect size of 0.811 (df=66; t=1.668). Considering the high power of the test and the losses in the study, a total of 76 people, 38 in the groups, will be reached.
Randomization: Randomization will be performed by a doctoral education nurse at the institution where the researcher, who is not involved in the study, works. The researcher will not intervene in the randomization list. Newly graduated nurses who meet the inclusion criteria and agree to participate in the study will be assigned to the intervention and control groups. Impartiality will be ensured by the random assignment of the intervention and control groups.
Blinding:
Since the patient safety language training will be provided by the researcher in the study, blinding the researcher will not be possible.
In order to blind the participants, all nurses in the intervention and control groups will think that they will receive the entire language training. It will be explained that the tests and trainings to be conducted regarding the study will be planned on different dates, notifications will be sent to mobile phones regarding the start and end times of the trainings, and the nurse whose turn it is will be called to the training. After the explanation, the same informed consent form will be signed by the intervention and control group nurses.
The statistician will perform the statistical analyses without knowing which group is the intervention and which group is the control. The randomization process was carried out in accordance with the CONSORT 2017 guidelines.
Descriptive Characteristics Form The Descriptive Characteristics Form consists of seven questions that will determine individual information such as nurses' age, gender, education level, unit they work in, working hours, and working style. In addition, the form will include two questions to determine nurses' views on voicing.
Employee Voice Scale Van Dyne and LePine (1998) developed the employee voice scale as a 6-item, single-dimensional scale. In our country, the Employee Voice Scale was adapted to Turkish by Çetin and Çakmakçı (2012). All items in the scale are measured according to a 5-point Likert scale. Higher scores indicate more employee voice behavior.
Effective Communication Skills Scale The Effective Communication Skills Scale consists of 5 sub-dimensions and a total of 34 items and was developed by Buluş et al. (2017). Items 15, 16, 28, 32 and 33 of the scale are scored reversely. Therefore, as the total score obtained from each sub-dimension increases, the level of using communication skills also increases.
Attitude Scale on Medical Errors The scale was developed by Güleç and İntepeler in 2012 and consists of three sub-dimensions, namely perception of medical error, approach to medical error and causes of medical errors, and 16 questions. The scale is a five-point Likert type. If the average score obtained from the scale is 3, it indicates that attitudes towards medical errors are negative, and if it is 3 and above, it indicates that attitudes towards medical errors are positive.
Evaluation Form for the Speak-up Training Program
Araştırmacı literatürü takip ederek dil eğitimlerinin birleştirilmesini sağlamak amacıyla hazırlandı. Bu form iki bölümden oluşur. Literatür taramasına dayalı birinci bölüm, eğitim programı içeriği, eğitim süresi, kullanılan öğretim bölümleri, değerlendirme yöntemi ve eğitimin algılanan etkililiği olmak üzere toplam 16 maddeden oluşmaktadır. İkinci bölüm, dil eğitim programları teorik ve video içeriği hakkında yayınlama soran dört açık uçlu sorudan oluşmaktadır.
İçerik Rekabetçilik Analizi İçerik bakımı, iletişim, hasta güvenliği, dil ve eğitim alanlarında 7 uzmana danışılarak değerlendirilmiştir. Formları amaç, hedefler, dil ve anlam açısından 4 puanlık Likert performansında derecelendirildiler (4: Çok uygun, 3: Küçük ayarlamalarla uygun, 2: Büyük ayarlamalarla uygun, 1: Uygun değil). Uzman yayın, içerik düzenliliği programlaması için Davis teknolojisi kullanılarak analiz edilmiştir.
Development of Speak-up Training Program
The language training program was developed using the ADDIE model. The model consists of analysis, design, development, implementation and evaluation stages.
The language training program was developed using the ADDIE model. The model consists of analysis, design, development, implementation and evaluation stages.
Analysis
The researcher conducted a nine-question interview with manager nurses, education and quality unit nurses, infection control nurses, hemovigilance nurses, responsible nurses and experienced nurses working at Etlik City Hospital and participating in the study voluntarily to determine the needs of the participants regarding the language training program. The researcher analyzed the characteristics, experiences and work environments of the participants and reviewed the hospital adverse event notification reports. The literature review was conducted as a retrospective review of publications to determine the content, learning objectives and learning areas of the training program. For this purpose, the keywords speak up, nurses, nursing, education, (training), intervention, program, curriculum, guide were used in the Turkish and English title and abstract fields from the Pubmed (29), Cohrane (4), Google Academy (33), Medline (38), Science Direct (12) databases between 2018-2023.
Design
The researcher determined the measurement and evaluation tools to be used in the study. Developed a language education program evaluation form. Created theoretical education contents, language video scenarios and video discussion questions.
Development
The content of the training program, the materials used, the measurement and evaluation tool and the scenarios were reviewed by the experts. The researcher made adjustments based on the feedback. The professional actors were informed about the scenario and the training video was shot. The researcher made a preliminary application of the training program and made the necessary corrections
Implementation
The implementation phase of the study includes the Implementation and Evaluation steps of the ADDIE design model.
Participants who will participate in the study will be informed about the training program, and the introductory information form and scales will be applied. Then, participants will be randomly selected and assigned to the research groups. One week after the completion of the pre-test applications, the implementation of the language training program for the experimental group will begin. In order to ensure effective and easy participation of the participants in the training, the "Speaking Up Training Program" trainings will be held in the Orthopedics-Neurology Hospital training class. Before the start of the training program, the training booklet containing advanced reading resources and training contents will be distributed to the experimental group participants. The language training program will consist of four sessions and each session will last 90 minutes.
Seven days after the completion of the training program, the final evaluation of the scales will be made to the experimental and control group nurses.
Analysis:
The data will be analyzed using a computer program. The normal distribution of variables will be evaluated with histogram, coefficient of variation, skewness, kurtosis, Kolmogorov-Smirnov and Shapiro-Wilk tests (p<0.05). Descriptive statistics (number, percentage, mean, standard deviation) and Chi-square tests will be used. Parametric tests will be applied to data showing normal distribution, and nonparametric tests will be applied to data not showing normal distribution. Independent sample t-test will be used for comparisons between two independent groups, ANOVA with Bonferroni correction for comparisons between two or more groups, and variance analysis for repeated measurements. Mann-Whitney U and Kruskal-Wallis H tests with Bonferroni correction will be applied for data not showing normal distribution. Randomization balance will be provided using Intention to Treat (ITT) analysis.
Limitations
A limitation of this study is that only new graduate nurses working in one hospital and who agreed to participate in the study were included in the study. The results cannot be generalized to all new graduate nurses.
The fact that the gender and professional experience characteristics of the newly graduated nurses included in the study were concentrated on one side limited the use of stratified block randomization.
- Conditions
- Patient Safety, Nurse Training, Communication
- Being tested
- Speak up traning program
- Keywords
- patient safety, newly graduated nurses, Speaking-Up, training program, transition shock, empowerment
- Medical subject headings
- Communication, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speak up traning programOther
The intervention includes the training program to be applied to the experimental group. The aims and objectives of the training program, the training content and modules were prepared by the researcher in line with the needs analysis. The training program consists of four modules: Communication, Speaking UP, Patient Safety and Medical Error. Before the training program starts, the training booklet will be distributed to the experimental group participants. In the training, teaching techniques such as plain narration, question and answer, brainstorming, case study, case discussion, station technique, six thinking hats technique, video-based error scenario activity etc. will be used. The video activity to be used in the speak up session of the training program was created by recording the correct and incorrect scenarios of three patient safety errors by experienced actors.
| Study group | Role | What they receive |
|---|---|---|
| SPEAKİNG UP TRAİNİNG GROUP | Experimental | A pre-test will be administered to all participants seven days before the training program begins. A language training program consisting of four modules will be given to the experimental group participants. The final test of the scales and the training program evaluation form will be administered to the experimental group participants seven days after the training program is completed. Receives: Other: Speak up traning program |
| NON-TRAİNİNG GROUP | No intervention | A pre-test will be applied to all participants seven days before the training program begins. No intervention will be made to the control group participants. The post-test of the scales will be applied to the control group again seven days after the training program of the experimental group participants is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employee Voice Scale
The Employee Voice Scale was developed by Van Dyne and LePine and is a 6-item, single-dimensional scale. In our country, the Employee Voice Scale was adapted to Turkish by Çetin and Çakmakçı. All items in the scale are measured on a 5-point Likert-type scale using the following scales: disagree, somewhat agree, partially agree, mostly agree, completely agree. Higher scores indicate more employee voice behavior.
Measured: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).
Secondary outcomes (3)
Effective Communication Skills Scale
The Effective Communication Skills Scale consists of 5 sub-dimensions and a total of 34 items. The scale consists of the sub-dimensions "ego-enhancing language" (6 items), "active listening" (8 items), "self-awareness/self-disclosure" (5 items), "empathy" (8 items) and "I language" (7 items). As the total score from each sub-dimension of the scale increases, the level of using communication skills also increases.
Measured: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).
Attitude Scale in Medical Errors
The scale was developed by Güleç and İntepeler and consists of three sub-dimensions, namely perception of medical error, approach to medical error and reasons for medical error, and 16 questions. The scale is a five-point Likert type. The items are Strongly disagree, Disagree, Undecided, Agree and Strongly agree. The total score of the scale varies between 1-5. The average score obtained from the scale is 3, indicating that attitudes towards medical errors are negative, and a score of 3 and above indicates that attitudes towards medical errors are positive.
Measured: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).
Evaluation Form for the Speaking-Up Training Program
The researcher prepared the form by following the relevant literature in order to measure the opinions on the language education program. This form consists of two parts. The first part, based on the literature review, consists of a total of 16 items, including the content of the education program, duration of education, teaching materials used, evaluation method and perceived effectiveness of education. The second part consists of four open-ended questions asking opinions on the theoretical and video content of the language education program.
Measured: It will be collected immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start20 Jul 2023
- Primary completion9 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a randomized, pretest-posttest control group, parallel group experimental study that will evaluate the effectiveness of the language training program developed for newly graduated nurses. An introductory information form and a pretest evaluation of the scales will be applied to the participants who accept to participate in the research seven days before the application. Then, the groups will be randomized by an expert other than the researcher and assigned to their groups. The language training program will be applied to the experimental group seven days after the pretest evaluations. No intervention will be made to the control group. The final evaluation of the scales will be made to both groups seven days after the experimental group participants complete the training program. The language training program evaluation form will also be applied to the experimental group participants and their opinions about the training program will be obtained.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Çalışkan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711484
- Sponsor's protocol ID
- 2023-946
- Other IDs
- 2024-9261
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akın, B. ve Koçoğlu, D. Randomize Kontrollü Deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi. 2017 4(1): 73-92.
Van Dyne, L. ve LePine, J.A. (1998). Helping and voice extra-role behavior: Evidence of construct and predictive validity. Academy of Management Journal, 41, 108-119.
Çetin, Ş. ve Çakmakçı, C. (2012). Çalışan Sesliliği Ölçeğini Türkçeye Uyarlama Çalışması. Kara Harp Okulu Bilim Dergisi, 22(2), 1.
Güleç, D. ve İntepeler, Ş.S. (2013). Tıbbi hatalarda tutum ölçeğinin geliştirilmesi. Hemşirelikte Araştırma Geliştirme Dergisi, 15:3, 26-41.
Buluş, M., Atan, A., & Sarıkaya, H. E. (2017). Effective Communication Skills: A New Concep-tual Framework and Scale Development Study. International Online Journal of Educational Sci-ences, 9(2).
Lee SE, Kim E, Lee JY, Morse BL. Assertiveness educational interventions for nursing students and nurses: A systematic review. Nurse Educ Today. 2023 Jan;120:105655. doi: 10.1016/j.nedt.2022.105655. Epub 2022 Nov 25.
PubMed 36462396Wawersik DM, Boutin ER Jr, Gore T, Palaganas JC. Individual Characteristics That Promote or Prevent Psychological Safety and Error Reporting in Healthcare: A Systematic Review. J Healthc Leadersh. 2023 Apr 17;15:59-70. doi: 10.2147/JHL.S369242. eCollection 2023.
PubMed 37091553Lee SE, Choi J, Lee H, Sang S, Lee H, Hong HC. Factors Influencing Nurses' Willingness to Speak Up Regarding Patient Safety in East Asia: A Systematic Review. Risk Manag Healthc Policy. 2021 Mar 12;14:1053-1063. doi: 10.2147/RMHP.S297349. eCollection 2021.
PubMed 33737846Lee E, De Gagne JC, Randall PS, Kim H, Tuttle B. Effectiveness of speak-up training programs for clinical nurses: A scoping review. Int J Nurs Stud. 2022 Dec;136:104375. doi: 10.1016/j.ijnurstu.2022.104375. Epub 2022 Oct 7.
PubMed 36327680O'Donovan R, McAuliffe E. A systematic review exploring the content and outcomes of interventions to improve psychological safety, speaking up and voice behaviour. BMC Health Serv Res. 2020 Feb 10;20(1):101. doi: 10.1186/s12913-020-4931-2.
PubMed 32041595
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effıciency Of Speaking Up Training Program Developed For Newly Graduate Nurses
- ClinicalTrials.gov ID
- NCT06711484
- Acronym / sponsor ID
- 2023-946
- Conditions
- Patient Safety, Nurse Training, Communication
- Keywords
- patient safety, newly graduated nurses, Speaking-Up, training program, transition shock, empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: This research is a randomized, pre-test post-test control group, parallel group experimental study to evaluate the effectiveness of the language training program developed for newly graduated nurses. The study will be conducted with a total of 76 newly graduated nurses, 38 in the experimental group and 38 in the control group, at Etlik City Hospital Orthopedics-Neurology Hospital in Ankara. Participants will be informed about the study at the beginning of the study. Participants who agree to participate in the study and meet the eligibility criteria will be randomly assigned to groups by an independent statistician. The language training program will be applied to the experimental group, while no intervention will be made to the control group. The training program to be given to the experimental group will consist of a total of two days and four sessions (communication, speaking, patient safety, medical error), and each session will last 90 minutes. Data collection forms will be applied to the experimental and control groups before and after the training. Data collection forms include the descriptive characteristics form, working voice scale, effective communication skills scale, attitude scale in medical errors, and feedback about the language training program. Blinding of the raters will be applied to the participants to minimize bias. Data analysis will use statistical software that uses parametric tests for normally distributed data and nonparametric tests for non-normally distributed data.
Detailed description
Purpose of the Study
The purpose of the study is to evaluate the effectiveness of the speak-up training program developed for newly graduated nurses.
Hypotheses of the Study H0-1: The speak-up training program has no effect on the employee voice levels of newly graduated nurses.
H1-1: The speak-up training program has an effect on the employee voice levels of newly graduated nurses.
H0-2: The speak-up training program has no effect on the effective communication skill levels of newly graduated nurses.
H1-2: The speak-up training program has an effect on the effective communication skill levels of newly graduated nurses.
H0-3: The speak-up training program has no effect on the medical error attitude levels of newly graduated nurses.
H1-3: The speak-up training program has an effect on the medical error attitude levels of newly graduated nurses.
Variables of the Study
Independent variables
- Socio-demographic characteristics of the new graduate nurses
Dependent variables
- Total score of the Employee Voice scale after the implementation of the training program developed for the speaking up of new graduate nurses
- Total and sub-dimension scores of the Communication Skills scale after the implementation of the training program developed for the speaking up of new graduate nurses Total and sub-dimension scores of the Attitude to Medical Errors scale after the implementation of the training program developed for the speaking up of new graduate nurses
- Evaluations of the training program developed for the lspeaking up of new graduate nurses
Population and Sample of the Study
The population of the study will consist of 152 newly graduated nurses working at Etlik City Hospital Campus Orthopedics-Neurology Hospital. The characteristics of the newly graduated nurses selected for this study are that they have completed basic nursing professional education, have been in the clinic for the first two years after graduation, and have not received speaking up training. The sample size of the study was determined by power analysis (G*Power 3.1 program). In a similar study in the relevant literature, in the study conducted by Walther et al. (2022), the effect size for the difference in vocalization between the groups (Effect size) was 0.811. In order to exceed the 95% value in determining the power of the study; 68 people, 34 in the groups, should be reached at a significance level of 5% and an effect size of 0.811 (df=66; t=1.668). Considering the high power of the test and the losses in the study, a total of 76 people, 38 in the groups, will be reached.
Randomization: Randomization will be performed by a doctoral education nurse at the institution where the researcher, who is not involved in the study, works. The researcher will not intervene in the randomization list. Newly graduated nurses who meet the inclusion criteria and agree to participate in the study will be assigned to the intervention and control groups. Impartiality will be ensured by the random assignment of the intervention and control groups.
Blinding:
Since the patient safety language training will be provided by the researcher in the study, blinding the researcher will not be possible.
In order to blind the participants, all nurses in the intervention and control groups will think that they will receive the entire language training. It will be explained that the tests and trainings to be conducted regarding the study will be planned on different dates, notifications will be sent to mobile phones regarding the start and end times of the trainings, and the nurse whose turn it is will be called to the training. After the explanation, the same informed consent form will be signed by the intervention and control group nurses.
The statistician will perform the statistical analyses without knowing which group is the intervention and which group is the control. The randomization process was carried out in accordance with the CONSORT 2017 guidelines.
Descriptive Characteristics Form The Descriptive Characteristics Form consists of seven questions that will determine individual information such as nurses' age, gender, education level, unit they work in, working hours, and working style. In addition, the form will include two questions to determine nurses' views on voicing.
Employee Voice Scale Van Dyne and LePine (1998) developed the employee voice scale as a 6-item, single-dimensional scale. In our country, the Employee Voice Scale was adapted to Turkish by Çetin and Çakmakçı (2012). All items in the scale are measured according to a 5-point Likert scale. Higher scores indicate more employee voice behavior.
Effective Communication Skills Scale The Effective Communication Skills Scale consists of 5 sub-dimensions and a total of 34 items and was developed by Buluş et al. (2017). Items 15, 16, 28, 32 and 33 of the scale are scored reversely. Therefore, as the total score obtained from each sub-dimension increases, the level of using communication skills also increases.
Attitude Scale on Medical Errors The scale was developed by Güleç and İntepeler in 2012 and consists of three sub-dimensions, namely perception of medical error, approach to medical error and causes of medical errors, and 16 questions. The scale is a five-point Likert type. If the average score obtained from the scale is 3, it indicates that attitudes towards medical errors are negative, and if it is 3 and above, it indicates that attitudes towards medical errors are positive.
Evaluation Form for the Speak-up Training Program
Araştırmacı literatürü takip ederek dil eğitimlerinin birleştirilmesini sağlamak amacıyla hazırlandı. Bu form iki bölümden oluşur. Literatür taramasına dayalı birinci bölüm, eğitim programı içeriği, eğitim süresi, kullanılan öğretim bölümleri, değerlendirme yöntemi ve eğitimin algılanan etkililiği olmak üzere toplam 16 maddeden oluşmaktadır. İkinci bölüm, dil eğitim programları teorik ve video içeriği hakkında yayınlama soran dört açık uçlu sorudan oluşmaktadır.
İçerik Rekabetçilik Analizi İçerik bakımı, iletişim, hasta güvenliği, dil ve eğitim alanlarında 7 uzmana danışılarak değerlendirilmiştir. Formları amaç, hedefler, dil ve anlam açısından 4 puanlık Likert performansında derecelendirildiler (4: Çok uygun, 3: Küçük ayarlamalarla uygun, 2: Büyük ayarlamalarla uygun, 1: Uygun değil). Uzman yayın, içerik düzenliliği programlaması için Davis teknolojisi kullanılarak analiz edilmiştir.
Development of Speak-up Training Program
The language training program was developed using the ADDIE model. The model consists of analysis, design, development, implementation and evaluation stages.
The language training program was developed using the ADDIE model. The model consists of analysis, design, development, implementation and evaluation stages.
Analysis
The researcher conducted a nine-question interview with manager nurses, education and quality unit nurses, infection control nurses, hemovigilance nurses, responsible nurses and experienced nurses working at Etlik City Hospital and participating in the study voluntarily to determine the needs of the participants regarding the language training program. The researcher analyzed the characteristics, experiences and work environments of the participants and reviewed the hospital adverse event notification reports. The literature review was conducted as a retrospective review of publications to determine the content, learning objectives and learning areas of the training program. For this purpose, the keywords speak up, nurses, nursing, education, (training), intervention, program, curriculum, guide were used in the Turkish and English title and abstract fields from the Pubmed (29), Cohrane (4), Google Academy (33), Medline (38), Science Direct (12) databases between 2018-2023.
Design
The researcher determined the measurement and evaluation tools to be used in the study. Developed a language education program evaluation form. Created theoretical education contents, language video scenarios and video discussion questions.
Development
The content of the training program, the materials used, the measurement and evaluation tool and the scenarios were reviewed by the experts. The researcher made adjustments based on the feedback. The professional actors were informed about the scenario and the training video was shot. The researcher made a preliminary application of the training program and made the necessary corrections
Implementation
The implementation phase of the study includes the Implementation and Evaluation steps of the ADDIE design model.
Participants who will participate in the study will be informed about the training program, and the introductory information form and scales will be applied. Then, participants will be randomly selected and assigned to the research groups. One week after the completion of the pre-test applications, the implementation of the language training program for the experimental group will begin. In order to ensure effective and easy participation of the participants in the training, the "Speaking Up Training Program" trainings will be held in the Orthopedics-Neurology Hospital training class. Before the start of the training program, the training booklet containing advanced reading resources and training contents will be distributed to the experimental group participants. The language training program will consist of four sessions and each session will last 90 minutes.
Seven days after the completion of the training program, the final evaluation of the scales will be made to the experimental and control group nurses.
Analysis:
The data will be analyzed using a computer program. The normal distribution of variables will be evaluated with histogram, coefficient of variation, skewness, kurtosis, Kolmogorov-Smirnov and Shapiro-Wilk tests (p<0.05). Descriptive statistics (number, percentage, mean, standard deviation) and Chi-square tests will be used. Parametric tests will be applied to data showing normal distribution, and nonparametric tests will be applied to data not showing normal distribution. Independent sample t-test will be used for comparisons between two independent groups, ANOVA with Bonferroni correction for comparisons between two or more groups, and variance analysis for repeated measurements. Mann-Whitney U and Kruskal-Wallis H tests with Bonferroni correction will be applied for data not showing normal distribution. Randomization balance will be provided using Intention to Treat (ITT) analysis.
Limitations
A limitation of this study is that only new graduate nurses working in one hospital and who agreed to participate in the study were included in the study. The results cannot be generalized to all new graduate nurses.
The fact that the gender and professional experience characteristics of the newly graduated nurses included in the study were concentrated on one side limited the use of stratified block randomization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a randomized, pretest-posttest control group, parallel group experimental study that will evaluate the effectiveness of the language training program developed for newly graduated nurses. An introductory information form and a pretest evaluation of the scales will be applied to the participants who accept to participate in the research seven days before the application. Then, the groups will be randomized by an expert other than the researcher and assigned to their groups. The language training program will be applied to the experimental group seven days after the pretest evaluations. No intervention will be made to the control group. The final evaluation of the scales will be made to both groups seven days after the experimental group participants complete the training program. The language training program evaluation form will also be applied to the experimental group participants and their opinions about the training program will be obtained.
| Arm | Type | Receives |
|---|---|---|
| SPEAKİNG UP TRAİNİNG GROUP | Experimental | Other: Speak up traning programA pre-test will be administered to all participants seven days before the training program begins. A language training program consisting of four modules will be given to the experimental group participants. The final test of the scales and the training program evaluation form will be administered to the experimental group participants seven days after the training program is completed. |
| NON-TRAİNİNG GROUP | No intervention | –A pre-test will be applied to all participants seven days before the training program begins. No intervention will be made to the control group participants. The post-test of the scales will be applied to the control group again seven days after the training program of the experimental group participants is completed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having a maximum of two years of post-graduation professional experience
- Having a minimum of three months of post-graduation professional experience
- Being willing to participate in the research
- Having completed general orientation training
Key exclusion criteria (5 listed)
- Having received previous training in language translation
- Those with education below undergraduate level
- Not having attended the entire training program
- Not having completed all the data collection tools
- Wanting to leave the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speak up traning programThe intervention includes the training program to be applied to the experimental group. The aims and objectives of the training program, the training content and modules were prepared by the researcher in line with the needs analysis. The training program consists of four modules: Communication, Speaking UP, Patient Safety and Medical Error. Before the training program starts, the training booklet will be distributed to the experimental group participants. In the training, teaching techniques such as plain narration, question and answer, brainstorming, case study, case discussion, station technique, six thinking hats technique, video-based error scenario activity etc. will be used. The video activity to be used in the speak up session of the training program was created by recording the correct and incorrect scenarios of three patient safety errors by experienced actors. | Other | SPEAKİNG UP TRAİNİNG GROUP |
Primary outcome
Employee Voice Scale
Time frame: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).
The Employee Voice Scale was developed by Van Dyne and LePine and is a 6-item, single-dimensional scale. In our country, the Employee Voice Scale was adapted to Turkish by Çetin and Çakmakçı. All items in the scale are measured on a 5-point Likert-type scale using the following scales: disagree, somewhat agree, partially agree, mostly agree, completely agree. Higher scores indicate more employee voice behavior.
3 secondary outcomes
Effective Communication Skills Scale
Time frame: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).
Attitude Scale in Medical Errors
Time frame: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).
Evaluation Form for the Speaking-Up Training Program
Time frame: It will be collected immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publicationAkın, B. ve Koçoğlu, D. Randomize Kontrollü Deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi. 2017 4(1): 73-92.
- Results publicationVan Dyne, L. ve LePine, J.A. (1998). Helping and voice extra-role behavior: Evidence of construct and predictive validity. Academy of Management Journal, 41, 108-119.
- Results publicationÇetin, Ş. ve Çakmakçı, C. (2012). Çalışan Sesliliği Ölçeğini Türkçeye Uyarlama Çalışması. Kara Harp Okulu Bilim Dergisi, 22(2), 1.
- Results publicationGüleç, D. ve İntepeler, Ş.S. (2013). Tıbbi hatalarda tutum ölçeğinin geliştirilmesi. Hemşirelikte Araştırma Geliştirme Dergisi, 15:3, 26-41.
- Results publicationBuluş, M., Atan, A., & Sarıkaya, H. E. (2017). Effective Communication Skills: A New Concep-tual Framework and Scale Development Study. International Online Journal of Educational Sci-ences, 9(2).
- Results publication: PubMed 36462396Lee SE, Kim E, Lee JY, Morse BL. Assertiveness educational interventions for nursing students and nurses: A systematic review. Nurse Educ Today. 2023 Jan;120:105655. doi: 10.1016/j.nedt.2022.105655. Epub 2022 Nov 25.
- Results publication: PubMed 37091553Wawersik DM, Boutin ER Jr, Gore T, Palaganas JC. Individual Characteristics That Promote or Prevent Psychological Safety and Error Reporting in Healthcare: A Systematic Review. J Healthc Leadersh. 2023 Apr 17;15:59-70. doi: 10.2147/JHL.S369242. eCollection 2023.
- Results publication: PubMed 33737846Lee SE, Choi J, Lee H, Sang S, Lee H, Hong HC. Factors Influencing Nurses' Willingness to Speak Up Regarding Patient Safety in East Asia: A Systematic Review. Risk Manag Healthc Policy. 2021 Mar 12;14:1053-1063. doi: 10.2147/RMHP.S297349. eCollection 2021.
- Results publication: PubMed 36327680Lee E, De Gagne JC, Randall PS, Kim H, Tuttle B. Effectiveness of speak-up training programs for clinical nurses: A scoping review. Int J Nurs Stud. 2022 Dec;136:104375. doi: 10.1016/j.ijnurstu.2022.104375. Epub 2022 Oct 7.
- Results publication: PubMed 32041595O'Donovan R, McAuliffe E. A systematic review exploring the content and outcomes of interventions to improve psychological safety, speaking up and voice behaviour. BMC Health Serv Res. 2020 Feb 10;20(1):101. doi: 10.1186/s12913-020-4931-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speak up traning program in people with Patient Safety and Nurse Training, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employee Voice Scale (time frame: It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711484, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.