StressNCT06259955
The Effect of Mindfulness Program on Clinical Stress Nursing Students
A study testing Mindfulness in people with Stress, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Nurses are important members of the team in the provision of health services, which determine and help the health needs of the individual, family and society, while working towards the protection and development of health, as well as taking responsibility in therapeutic services. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2022to 17 Jun 2022
- 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
- Not having participated in a mindfulness study before
- Being a second year student
- Volunteering
Who cannot join
- Being a foreign national (due to the problem of speaking/understanding Turkish)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness Program on Clinical Stress, Clinical Decision Making and Personality Traits in Nursing
Nurses are important members of the team in the provision of health services, which determine and help the health needs of the individual, family and society, while working towards the protection and development of health, as well as taking responsibility in therapeutic services. Nurses, who are permanent members of the professional health team, need to be trained with certain skills for effective nursing care while they are still in the education process. These skills are essential skills in practice, such as critical thinking, clinical decision making, communication, creativity, coping with stress, and problem solving. The education process consists of two parts, theoretical and practical, in order to develop these skills. Clinical practical training is the cornerstone of nursing education.
Clinical practice helps to provide effective and quality care by increasing the psycho-motor skills, analysis ability and clinical decision-making skills of the student. In studies conducted with nursing students, it is seen that clinical practices are among the most important sources of stress.
Read more
Considering the reasons for the stress they experience in practice; practice for the first time, fear of making mistakes, harming the patient, difficulty in making clinical decisions, communication with nurses, lecturers and friends, lack of information, and self-confidence problems.
It is seen in the results of studies that students who experience stress in clinical practice have difficulty in decision making, decrease in their performance and self-confidence, decrease in professional career motivation, and a high tendency to make medical mistakes. Strategies for coping with stress are important when experiencing and managing stress. There are two types of coping strategies: problem-based and emotion-based. While problem-based coping aims to change the stressful event, the aim of emotion-based coping is to suppress and manage the emotions related to the stressful event. Stress mechanism and levels do not show effective results through problem-based coping alone. Emotion-based coping processes are also important. Orientation programs, simulation trainings, and laboratory practices with nursing students focus only on the knowledge level of clinical stress.There is also a need for studies on the emotional aspect of stress in the application areas. Being able to cope with stress effectively is important for students to benefit from the theoretical and clinical education they receive in a quality manner, to create a good experience and professional identity, and to develop effective coping behaviors.
Read the detailed description
It is seen that clinical use with nursing beds is at the beginning of the most important stress periods. Take a look at the reasons for the stress they experience in practice; practice for the first time, fear of offspring, harming the past, difficulty in clinical decision making, communication with administrators, faculty members and friends, lack of knowledge, and lack of self-confidence. It is seen in the results of studies that students who experience stress in the clinic have difficulty in making decisions, decrease in performance and self-confidence, decrease in career motivation, and not making clean mistakes.
White reported that high anxiety measures are at the forefront of emotional states after making a clinical decision in the workplace. After an observation made by Coram , it was decided that students' anxiety caused their self-confidence to decrease and that it would negatively affect their ability to provide clinical care necessary to provide care safely. An observation made at the University of Pittsburgh is that Observation students are more successful in reaching the clinical examination than students with high self-confidence and low stress levels. Sharpnack et al. Its actions are intended to prevent appropriate clinical decision making in maternity students because of their high anxiety.
It is important for physicians working at the forefront of patient care to make good choices and make sound clinical decisions to ensure quality care.
Nursing education gains importance in the planning of the activities of various educators in providing students with aspects of clinical management coping with stress, improving clinical decision-making skills and the consequences of productive error managers.
Developing the ability to cope with stress in nursing students provides a basis for improving their clinical decision making. Conscious planning configurations are used to structure the savings, savings and stress management management and productivity of computer science students. Awareness refers to an internal perception that is intended to help individuals concentrate on the present and their environment without being distracted by organs of the past or structures.
The Kabat-Zin approach defined existing concepts to show a focused and purposeful attention to the center without judgment. Considering the ease, ease of application, and potential positive effects of awareness interpretations, many countries seem to have done a great deal of empirical work on the procedures of formal educators.
Some evidence shows that adopting temperature configurations can significantly increase temperature ranges and reduce the stress, anxiety and storage of care students.
- Conditions
- Stress
- Being tested
- Mindfulness
- Keywords
- clinical stress, Nursing students, clinical decision, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessOther
In the hybrid education process, the group that received their first year education online realized their first face-to-face clinical practice this year. In the fall semester, internal medicine nursing course and practice, and in the spring semester, surgical diseases nursing course and practice. These two practice areas, which have a high tendency to make medical errors, require clinical decision-making skills and increase stress levels, constitute the beginning of clinical practice. Studies show that the most stressful period for students is the second year of their education (Alzayyat \& Al- Gamal, 2014; White, 2011; Coram, 2015). This is because their professional knowledge and skills are not yet fully developed and they are not sufficiently prepared to meet the demands for higher level knowledge and skills (Alzayyat \& Al- Gamal, 2014; Coram, 2015). Based on the results of these studies, our study group consisted of second-year students.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The trainings were conducted in Gazi University Faculty of Health Sciences Seminar Hall and Nursing Practice Laboratory with one group on Monday and Tuesday and the other group on Wednesday and Thursday. Students could miss the eight-session program at most two times. It was planned to make up for the absent course in consultation with the instructor. 37 Students attended the training regularly. Receives: Other: Mindfulness |
| control group | No intervention | Throughout the study, the control group continued its routine lecture and clinical practice program. They were called only at the end of the course for the pre-test, interim measurement and post-test on the course days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical stress score
The Clinical Stress Questionnaire (CSQ) is a five-point Likert-type questionnaire consisting of 20 items to measure the initial degree of stress experienced by nursing students on the first day of clinical practice (Pagana, 1989). The questionnaire is organised under four dimensions consisting of threat, struggle, harm and benefit feelings. Each item is analysed on a 5-point scale. In the options, 0- not at all, 1- a little, 2- moderately, 3- very much, 4- very much. A minimum of 0 and a maximum of 80 points can be obtained from the questionnaire form. A low score reveals that the stress level is low, while a high score reveals that it is high.
Measured: pre-test:23.05.2022/ intermediate-test: 2 weeks after pretest / post test: 2 weeks after intermediate test
Secondary outcomes (1)
self-confidence and anxiety scores in clinical decision making
This scale developed by Krista A. White in 2014 assesses nursing students' anxiety and self-confidence in clinical decision making (White, 2014). The scale consists of two sections, self-confidence and anxiety, and these sections are scored within themselves. The scale consists of 27 questions in total. The lowest score that can be obtained from the two sub-dimensions of the scale is 27 and the highest score is 162. For both the self-confidence and anxiety sections of the scale, there are three sub-dimensions: "Using sources to obtain information and listening fully (13 questions)", "Using available information to identify the problem (7 questions)" and "Knowing and taking action (7 questions)".
Measured: pre-test:23.05.2022/ intermediate-test: 2 weeks after pretest / post test: 2 weeks after intermediate test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start23 May 2022
- Primary completion3 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Betül Öz, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259955
- Sponsor's protocol ID
- GazıUnıversity-Nursıng-FBOz
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Program on Clinical Stress, Clinical Decision Making and Personality Traits in Nursing
- ClinicalTrials.gov ID
- NCT06259955
- Acronym / sponsor ID
- GazıUnıversity-Nursıng-FBOz
- Conditions
- Stress
- Keywords
- clinical stress, Nursing students, clinical decision, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 14 Feb 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.
Nurses are important members of the team in the provision of health services, which determine and help the health needs of the individual, family and society, while working towards the protection and development of health, as well as taking responsibility in therapeutic services. Nurses, who are permanent members of the professional health team, need to be trained with certain skills for effective nursing care while they are still in the education process. These skills are essential skills in practice, such as critical thinking, clinical decision making, communication, creativity, coping with stress, and problem solving. The education process consists of two parts, theoretical and practical, in order to develop these skills. Clinical practical training is the cornerstone of nursing education.
Clinical practice helps to provide effective and quality care by increasing the psycho-motor skills, analysis ability and clinical decision-making skills of the student. In studies conducted with nursing students, it is seen that clinical practices are among the most important sources of stress.
Considering the reasons for the stress they experience in practice; practice for the first time, fear of making mistakes, harming the patient, difficulty in making clinical decisions, communication with nurses, lecturers and friends, lack of information, and self-confidence problems.
It is seen in the results of studies that students who experience stress in clinical practice have difficulty in decision making, decrease in their performance and self-confidence, decrease in professional career motivation, and a high tendency to make medical mistakes. Strategies for coping with stress are important when experiencing and managing stress. There are two types of coping strategies: problem-based and emotion-based. While problem-based coping aims to change the stressful event, the aim of emotion-based coping is to suppress and manage the emotions related to the stressful event. Stress mechanism and levels do not show effective results through problem-based coping alone. Emotion-based coping processes are also important. Orientation programs, simulation trainings, and laboratory practices with nursing students focus only on the knowledge level of clinical stress.There is also a need for studies on the emotional aspect of stress in the application areas. Being able to cope with stress effectively is important for students to benefit from the theoretical and clinical education they receive in a quality manner, to create a good experience and professional identity, and to develop effective coping behaviors.
Detailed description
It is seen that clinical use with nursing beds is at the beginning of the most important stress periods. Take a look at the reasons for the stress they experience in practice; practice for the first time, fear of offspring, harming the past, difficulty in clinical decision making, communication with administrators, faculty members and friends, lack of knowledge, and lack of self-confidence. It is seen in the results of studies that students who experience stress in the clinic have difficulty in making decisions, decrease in performance and self-confidence, decrease in career motivation, and not making clean mistakes.
White reported that high anxiety measures are at the forefront of emotional states after making a clinical decision in the workplace. After an observation made by Coram , it was decided that students' anxiety caused their self-confidence to decrease and that it would negatively affect their ability to provide clinical care necessary to provide care safely. An observation made at the University of Pittsburgh is that Observation students are more successful in reaching the clinical examination than students with high self-confidence and low stress levels. Sharpnack et al. Its actions are intended to prevent appropriate clinical decision making in maternity students because of their high anxiety.
It is important for physicians working at the forefront of patient care to make good choices and make sound clinical decisions to ensure quality care.
Nursing education gains importance in the planning of the activities of various educators in providing students with aspects of clinical management coping with stress, improving clinical decision-making skills and the consequences of productive error managers.
Developing the ability to cope with stress in nursing students provides a basis for improving their clinical decision making. Conscious planning configurations are used to structure the savings, savings and stress management management and productivity of computer science students. Awareness refers to an internal perception that is intended to help individuals concentrate on the present and their environment without being distracted by organs of the past or structures.
The Kabat-Zin approach defined existing concepts to show a focused and purposeful attention to the center without judgment. Considering the ease, ease of application, and potential positive effects of awareness interpretations, many countries seem to have done a great deal of empirical work on the procedures of formal educators.
Some evidence shows that adopting temperature configurations can significantly increase temperature ranges and reduce the stress, anxiety and storage of care students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: MindfulnessThe trainings were conducted in Gazi University Faculty of Health Sciences Seminar Hall and Nursing Practice Laboratory with one group on Monday and Tuesday and the other group on Wednesday and Thursday. Students could miss the eight-session program at most two times. It was planned to make up for the absent course in consultation with the instructor. 37 Students attended the training regularly. |
| control group | No intervention | –Throughout the study, the control group continued its routine lecture and clinical practice program. They were called only at the end of the course for the pre-test, interim measurement and post-test on the course days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Not having participated in a mindfulness study before
- Being a second year student
- Volunteering
Key exclusion criteria (1 listed)
- Being a foreign national (due to the problem of speaking/understanding Turkish)
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 |
|---|---|---|
| MindfulnessIn the hybrid education process, the group that received their first year education online realized their first face-to-face clinical practice this year. In the fall semester, internal medicine nursing course and practice, and in the spring semester, surgical diseases nursing course and practice. These two practice areas, which have a high tendency to make medical errors, require clinical decision-making skills and increase stress levels, constitute the beginning of clinical practice. Studies show that the most stressful period for students is the second year of their education (Alzayyat \& Al- Gamal, 2014; White, 2011; Coram, 2015). This is because their professional knowledge and skills are not yet fully developed and they are not sufficiently prepared to meet the demands for higher level knowledge and skills (Alzayyat \& Al- Gamal, 2014; Coram, 2015). Based on the results of these studies, our study group consisted of second-year students. | Other | intervention group |
Primary outcome
clinical stress score
Time frame: pre-test:23.05.2022/ intermediate-test: 2 weeks after pretest / post test: 2 weeks after intermediate test
The Clinical Stress Questionnaire (CSQ) is a five-point Likert-type questionnaire consisting of 20 items to measure the initial degree of stress experienced by nursing students on the first day of clinical practice (Pagana, 1989). The questionnaire is organised under four dimensions consisting of threat, struggle, harm and benefit feelings. Each item is analysed on a 5-point scale. In the options, 0- not at all, 1- a little, 2- moderately, 3- very much, 4- very much. A minimum of 0 and a maximum of 80 points can be obtained from the questionnaire form. A low score reveals that the stress level is low, while a high score reveals that it is high.
1 secondary outcome
self-confidence and anxiety scores in clinical decision making
Time frame: pre-test:23.05.2022/ intermediate-test: 2 weeks after pretest / post test: 2 weeks after intermediate test
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 14 Feb 2024.
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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 Mindfulness in people with Stress, 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 3 inclusion and 1 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 14 Feb 2024. 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?
clinical stress score (time frame: pre-test:23.05.2022/ intermediate-test: 2 weeks after pretest / post test: 2 weeks after intermediate test). 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 14 Feb 2024.