Simulation-based TrainingSPCSAONNCT07087470
Simulation Psychosocial Care Skills and Oncology Nursing
A study testing Simulation-based education and classical education and classical education in people with Simulation-based Training, run by Uskudar University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to reveal the effect of simulation-based experience-based psychosocial care skills development programme on psychosocial care skills competence and professional quality of life of nurses working with oncology patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Training
- What is being tested?
- Simulation-based education and classical education and classical education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 6 months or more experience of working with oncology patients
- Not having received training on psychosocial care skills after graduation
- Oncology nurses who volunteered to participate in the study
Who cannot join
- Having less than 6 months of experience working with oncology patients
- To have received training on psychosocial care skills after graduation
- Not volunteering to participate in the research
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Tülay Demiray
Istanbul, Turkey, 50506
tülay demiray, PHD STUDENT, 05317177435, tulay.demiray@uskudar.edu.tr
Selma Doğan, Prof. Dr., 05425664335, selma.dogan@uskudar.edu.tr
- Recruiting
Acibadem Altunizade Hospital
Istanbul
Kıymet Yılmaz, 905465566466, kiymet.yilmaz@acibadem.com
About this study
Official title: The Effect of Simulation Based Psychosocial Care Skill Development Programme on Psychosocial Care Competencies and Professional Life Quality of Oncology Nurses
The aim of this study was to reveal the effect of simulation-based experience-based psychosocial care skills development programme on psychosocial care skills competence and professional quality of life of nurses working with oncology patients.
The hypotheses of the study will be tested in accordance with the following guidelines.
Read more
Hypothesis 1 The post-training psychosocial care competency levels of the nurses who underwent simulation-based psychosocial care skills development programme (SDPBSP) are higher than the group who underwent standard psychosocial care skills training (SPBBE).
Hypothesis 2 The post-training compassion fatigue levels of the nurses who underwent the SDPBI development programme were lower than the SPBBE group.
Hypothesis 3 The post-training burnout score levels of the nurses who underwent SPBBE development programme were lower than the group who underwent standard SPBBE.
Hypothesis 4 The post-training compassion satisfaction levels of the nurses who underwent SPBBE development programme are higher than the group who underwent standard SPBBE.
Hypothesis 5
The psychosocial care competency levels of the nurses who underwent SPBBE development programme at the 1-month post-training follow-up were higher than those who did not receive SPBBE training.
Hypothesis 6 At the 1-month follow-up after the training, the compassion fatigue levels of the nurses who underwent SPBBE development programme were lower than the group who underwent SPBBE and did not receive training.
Hypothesis 7 In the 1-month follow-up after the training, the mean burnout scores of the nurses who underwent SPBBE development programme were lower than those of the group who underwent SPBBE and did not receive training.
Hypothesis 8 In the 1-month follow-up after the training, the mean compassion satisfaction scores of the nurses who underwent the SPBBE development programme were higher than the SPBBE training and non-training groups.
Hypothesis 9 After the SDPBE programme, the psychosocial skills training scores of those who received SDPBE are higher than those who did not receive training.
Hypothesis 10 At the 1-month follow-up after the SDPBE programme, the psychosocial skills training scores of those who received SDPBE were higher than those who did not receive training.
Read the detailed description
The research will be applied to nurses working with oncology patients and will be randomised controlled and consist of 3 groups.
The groups will be studied as follows. Group 1: Data collection tools related to Simulation Based Psychosocial Care Skills Development Programme
- Participant Information Form
- Psychosocial Care Competence Self-Assessment Scale (PSCSAS)
- Professional Quality of Life Scale (PQLS)
- Student Satisfaction and Self-Confidence Scale in Learning
- Simulation Design Scale
Group 2: Data collection tools related to the group to be trained on Classical Psychosocial Care Skills
- Participant Information Form
- Psychosocial Care Competence Self-Assessment Scale (PSCSAS)
- Professional Quality of Life Scale (PQLS)
Group 3: Data collection tools related to the control group (group that did not receive training)
- Participant Information Form
- Psychosocial Care Competence Self-Assessment Scale (PSCSAS)
- Professional Quality of Life Scale (PQLS)
- Conditions
- Simulation-based Training
- Being tested
- Simulation-based education and classical education, classical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based education and classical educationBehavioural
Simulation-based psychosocial care skills training and classical psychosocial care skills training will be prepared for oncology nurses.
classical educationBehavioural
classical psychosocial care skills training will be prepared for oncology nurses.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Standart psychosocial care skills training | Active comparator | Nurses Receiving Simulation Based Training and classical psychosocial care skills training Receives: Behavioral: Simulation-based education and classical education |
| Group 2 | Active comparator | only the group that will receive training in classical psychosocial care skills Receives: Behavioral: classical education |
| Group 3 | No intervention | No training will be given to any group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of nurses' psychosocial care competence
Psychosocial Care Competence Self-Assessment Scale (PBYÖDÖ), is a tool that assesses the psychosocial care competence of nurses working in clinics and the extent to which staff focus on the psychosocial aspects of patients while providing treatment and care. The scale, whose validity and reliability were established by Karataş (2019), consists of 18 items and 4 factors (sub-dimensions). The first factor, "Symptom Diagnosis," includes statements 1, 2, 3, 4, and 5, which are related to symptom diagnosis, for a total of 5 items. The second factor, "Use of Information," includes statements 6, 7, 8, 9, and 10, which are related to the use of information and comprise a total of 5 items. The third factor, "Intervention," includes statements 11, 12, 13, and 14, which are related to the use of information and comprise a total of 4 items. The fourth factor, "Diagnosis," includes statements 15, 16, 17, and 18, which are related to diagnosis and cover a total of 4 items. Respondents ar
Measured: T1: Baseline, T2: 1. Day, T3: 1 Months post- intervention
Evaluation of Student Satisfaction and Self-Confidence in Learning in Simulation Applications
Student Satisfaction and Self-Confidence Scale in Learning: The psychometric measurements of the scale developed by Jeffries (2012) to assess student satisfaction and self-confidence and used in simulation-based education were conducted by Franklin et al. (2014). The Turkish validity and reliability study of the scale was conducted by Ünver et al. (2017). According to the Turkish adaptation of the scale for learning in a simulation environment, the total number of items is 12. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Confidence in Learning." The "Satisfaction with Current Learning" subheading consists of five items, while the "Confidence in Learning" subheading consists of seven items. There are no negative items in the scale. A 5-point Likert scale with the following statements was used: 1) Strongly Disagree, 2) Disagree, 3) Undecided, 4) Agree, and 5) Strongly Agree. The Cronbach Alpha value for "Current Learning Satisfaction" is 0.85, and the
Measured: T1: Baseline, T2: 1 day post education, TE: 1 Months post intervention
Assessment of nurses' professional quality of life
Professional Quality of Life Scale (PYKÖ) was developed by Stamm (2005) and consists of the subdimensions of compassion satisfaction, compassion fatigue, and burnout. The Turkish adaptation of the scale was conducted by Yeşil et al. (2010) and consists of thirty items and three subscales. Compassion satisfaction (job satisfaction) is the first of the subscales and refers to the sense of satisfaction and contentment an employee feels as a result of helping another person in need in their profession or job. Items 3, 6, 12, 16, 18, 20, 22, 24, 27, and 30 on the scale measure job satisfaction (Min 0-Max 50). A high score on this subscale indicates increased satisfaction or fulfillment as a helper. The second subscale, burnout, is a test that measures feelings of exhaustion arising from difficulties in coping with problems in work life. Items 1, 4, 8, 10, 15, 17, 19, 21, 26, and 29 on the scale measure burnout (Min 0-Max 25). A high score on this subscale indicates a high level of burnout
Measured: T1: Baseline, T2: 1 day post education, TE: 1 Months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Mar 2025
- Primary completion10 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based TrainingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Maslak Hospital, Acıbadem Atunizade Hospital, Acibadem Atakent University Hospital
- Responsible party
- Principal investigator, tülay demiray, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087470
- Sponsor's protocol ID
- UU-HB-TDEMİRAY-001
- Acronym
- SPCSAON
- Status last verified
- Jul 2025
- First submitted
- 1 May 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation Based Psychosocial Care Skill Development Programme on Psychosocial Care Competencies and Professional Life Quality of Oncology Nurses
- ClinicalTrials.gov ID
- NCT07087470
- Acronym / sponsor ID
- SPCSAON / UU-HB-TDEMİRAY-001
- Conditions
- Simulation-based Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Acibadem Maslak Hospital, Acıbadem Atunizade Hospital, Acibadem Atakent University Hospital
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Jul 2025 (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.
The aim of this study was to reveal the effect of simulation-based experience-based psychosocial care skills development programme on psychosocial care skills competence and professional quality of life of nurses working with oncology patients.
The hypotheses of the study will be tested in accordance with the following guidelines.
Hypothesis 1 The post-training psychosocial care competency levels of the nurses who underwent simulation-based psychosocial care skills development programme (SDPBSP) are higher than the group who underwent standard psychosocial care skills training (SPBBE).
Hypothesis 2 The post-training compassion fatigue levels of the nurses who underwent the SDPBI development programme were lower than the SPBBE group.
Hypothesis 3 The post-training burnout score levels of the nurses who underwent SPBBE development programme were lower than the group who underwent standard SPBBE.
Hypothesis 4 The post-training compassion satisfaction levels of the nurses who underwent SPBBE development programme are higher than the group who underwent standard SPBBE.
Hypothesis 5
The psychosocial care competency levels of the nurses who underwent SPBBE development programme at the 1-month post-training follow-up were higher than those who did not receive SPBBE training.
Hypothesis 6 At the 1-month follow-up after the training, the compassion fatigue levels of the nurses who underwent SPBBE development programme were lower than the group who underwent SPBBE and did not receive training.
Hypothesis 7 In the 1-month follow-up after the training, the mean burnout scores of the nurses who underwent SPBBE development programme were lower than those of the group who underwent SPBBE and did not receive training.
Hypothesis 8 In the 1-month follow-up after the training, the mean compassion satisfaction scores of the nurses who underwent the SPBBE development programme were higher than the SPBBE training and non-training groups.
Hypothesis 9 After the SDPBE programme, the psychosocial skills training scores of those who received SDPBE are higher than those who did not receive training.
Hypothesis 10 At the 1-month follow-up after the SDPBE programme, the psychosocial skills training scores of those who received SDPBE were higher than those who did not receive training.
Detailed description
The research will be applied to nurses working with oncology patients and will be randomised controlled and consist of 3 groups.
The groups will be studied as follows. Group 1: Data collection tools related to Simulation Based Psychosocial Care Skills Development Programme
- Participant Information Form
- Psychosocial Care Competence Self-Assessment Scale (PSCSAS)
- Professional Quality of Life Scale (PQLS)
- Student Satisfaction and Self-Confidence Scale in Learning
- Simulation Design Scale
Group 2: Data collection tools related to the group to be trained on Classical Psychosocial Care Skills
- Participant Information Form
- Psychosocial Care Competence Self-Assessment Scale (PSCSAS)
- Professional Quality of Life Scale (PQLS)
Group 3: Data collection tools related to the control group (group that did not receive training)
- Participant Information Form
- Psychosocial Care Competence Self-Assessment Scale (PSCSAS)
- Professional Quality of Life Scale (PQLS)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group 1 Standart psychosocial care skills training | Active comparator | Behavioral: Simulation-based education and classical educationNurses Receiving Simulation Based Training and classical psychosocial care skills training |
| Group 2 | Active comparator | Behavioral: classical educationonly the group that will receive training in classical psychosocial care skills |
| Group 3 | No intervention | –No training will be given to any group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 6 months or more experience of working with oncology patients
- Not having received training on psychosocial care skills after graduation
- Oncology nurses who volunteered to participate in the study
Key exclusion criteria (3 listed)
- Having less than 6 months of experience working with oncology patients
- To have received training on psychosocial care skills after graduation
- Not volunteering to participate in the research
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 |
|---|---|---|
| Simulation-based education and classical educationSimulation-based psychosocial care skills training and classical psychosocial care skills training will be prepared for oncology nurses. | Behavioural | Group 1 Standart psychosocial care skills training |
| classical educationclassical psychosocial care skills training will be prepared for oncology nurses. | Behavioural | Group 2 |
Primary outcome
Assessment of nurses' psychosocial care competence
Time frame: T1: Baseline, T2: 1. Day, T3: 1 Months post- intervention
Psychosocial Care Competence Self-Assessment Scale (PBYÖDÖ), is a tool that assesses the psychosocial care competence of nurses working in clinics and the extent to which staff focus on the psychosocial aspects of patients while providing treatment and care. The scale, whose validity and reliability were established by Karataş (2019), consists of 18 items and 4 factors (sub-dimensions). The first factor, "Symptom Diagnosis," includes statements 1, 2, 3, 4, and 5, which are related to symptom diagnosis, for a total of 5 items. The second factor, "Use of Information," includes statements 6, 7, 8, 9, and 10, which are related to the use of information and comprise a total of 5 items. The third factor, "Intervention," includes statements 11, 12, 13, and 14, which are related to the use of information and comprise a total of 4 items. The fourth factor, "Diagnosis," includes statements 15, 16, 17, and 18, which are related to diagnosis and cover a total of 4 items. Respondents ar
Evaluation of Student Satisfaction and Self-Confidence in Learning in Simulation Applications
Time frame: T1: Baseline, T2: 1 day post education, TE: 1 Months post intervention
Student Satisfaction and Self-Confidence Scale in Learning: The psychometric measurements of the scale developed by Jeffries (2012) to assess student satisfaction and self-confidence and used in simulation-based education were conducted by Franklin et al. (2014). The Turkish validity and reliability study of the scale was conducted by Ünver et al. (2017). According to the Turkish adaptation of the scale for learning in a simulation environment, the total number of items is 12. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Confidence in Learning." The "Satisfaction with Current Learning" subheading consists of five items, while the "Confidence in Learning" subheading consists of seven items. There are no negative items in the scale. A 5-point Likert scale with the following statements was used: 1) Strongly Disagree, 2) Disagree, 3) Undecided, 4) Agree, and 5) Strongly Agree. The Cronbach Alpha value for "Current Learning Satisfaction" is 0.85, and the
Assessment of nurses' professional quality of life
Time frame: T1: Baseline, T2: 1 day post education, TE: 1 Months post intervention
Professional Quality of Life Scale (PYKÖ) was developed by Stamm (2005) and consists of the subdimensions of compassion satisfaction, compassion fatigue, and burnout. The Turkish adaptation of the scale was conducted by Yeşil et al. (2010) and consists of thirty items and three subscales. Compassion satisfaction (job satisfaction) is the first of the subscales and refers to the sense of satisfaction and contentment an employee feels as a result of helping another person in need in their profession or job. Items 3, 6, 12, 16, 18, 20, 22, 24, 27, and 30 on the scale measure job satisfaction (Min 0-Max 50). A high score on this subscale indicates increased satisfaction or fulfillment as a helper. The second subscale, burnout, is a test that measures feelings of exhaustion arising from difficulties in coping with problems in work life. Items 1, 4, 8, 10, 15, 17, 19, 21, 26, and 29 on the scale measure burnout (Min 0-Max 25). A high score on this subscale indicates a high level of burnout
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based education and classical education and classical education in people with Simulation-based Training, run by Uskudar University at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of nurses' psychosocial care competence (time frame: T1: Baseline, T2: 1. Day, T3: 1 Months post- intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.