StressNCT06008236
The Effect of Progressive Relaxation and Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses
A study testing Progressive Muscle Relaxation and Breathing Exercises in people with Stress and Stress, Physiological, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This clinical study will be conducted to determine the effects of musically accompanied progressive muscle relaxation and deep breathing exercises on nursing students' stress levels and bio-psycho-social responses to stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress, Physiological
- What is being tested?
- Progressive Muscle Relaxation and Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2022to 6 Jan 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be a nursing student who is studying at Gulhane Nursing Faculty of Health Sciences University and going on internship
- Not to have any obstacles in oral and written communication in Turkish
- Volunteering to participate in research
Who cannot join
- If the student has a disease that prevents the relaxation exercise (Heart Failure, Musculoskeletal System Problem, etc.)
- The student is participating in another relaxation program
- The student is taking a psychiatric medication that has a relaxing effect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses to Stress
This clinical study will be conducted to determine the effects of musically accompanied progressive muscle relaxation and deep breathing exercises on nursing students' stress levels and bio-psycho-social responses to stress.
Do musical progressive muscle relaxation and deep breathing exercises have an impact on nursing students' stress levels and bio-psycho-social responses to stress?
After students fill in the scales, they will be randomly assigned to the experimental and control groups. The experimental group will be given progressive muscle relaxation and deep breathing exercises accompanied by music once a week for six weeks by the researcher. There will be no intervention in the control group. The scales will be reapplied to the experimental and control groups in the week after the application is completed and two weeks after the application is completed. Groups will be compared and statistical analyzes will be made.
Read the detailed description
Stress is a psychosocial factor that affects students' academic performance and well-being. The presence and level of stress have a positive or negative impact on learning and thinking, and students show behavioral, emotional, and physical symptoms of experiencing stress For this reason, it is very important for university students to apply stress reduction methods, especially non-drug methods. Progressive relaxation and deep breathing exercises with music are effective methods of coping with stress. When the literature is examined, it is seen that the use of music has recently been effective in reducing the anxiety and stress experienced by many students during the education process. At the same time, a progressive relaxation exercise integrated with deep breathing exercises helps a person to feel the difference between tension and laxity in the body and allows the person to learn to relax on their own, thus reducing physical and emotional tension. Thus, the individual moves away from disturbing stimuli that reduce the quality of life such as anxiety, pain, and stress. In accordance with the nursing education program carried out with theoretical and practical application course hours, students considering the stress they are exposed to and the behavioral, emotional, and physical problems that arise with stress, there is a need for research that uses mind-body applications to support nursing students. At the end of the research, it is foreseen that the stress levels of nursing students and the symptoms seen due to stress can be reduced.
Method: The universe of the study will consist of 2nd, 3rd, and 4th year nursing undergraduate students who are studying and interning at Gülhane Nursing Faculty of Health Sciences University in 2022-2023. As a result of the power analysis, the minimum sample size was found to be 140 students, with 70 students in each group. During the study, in order to strengthen the results of the research and increase reliability, it was determined that the sample was 154 students with 77 experiments and 77 control groups with an increase of at least 10%. Student sampling; After each class is evaluated as a layer, proportional stratification will be taken by sampling method according to layer weight (number of students). 44 students from 2nd grade, 52 students from 3rd grade, and 58 students from 4th grade will participate in the research. Students have completed the Voluntary Consent Form for Nursing Students, Personal Information Form, Perceived Stress, and Bio-psycho-social Response Scale, then students who meet the inclusion criteria will be randomly assigned to intervention and control groups. Exercises will be applied to the intervention groups for 6 weeks. There will be no intervention in the control group. At the end of 6 weeks and 2 weeks after the last application (8. Weeks) intervention and control groups will refill the scales.
- Conditions
- Stress, Stress, Physiological
- Being tested
- Progressive Muscle Relaxation and Breathing Exercises
- Keywords
- Progressive muscle exercises, Breathing, Stress
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation and Breathing ExercisesBehavioural
Progressive relaxation exercise is a method that provides relaxation in the whole body by voluntary, regular relaxation of large muscle groups in the human body. Exercise helps individuals to be able to feel the difference between tension in the muscles and relaxation, and to learn to relax on their own in case of tension. Deep breathing exercise supports the maximum ventilation of the lung by correct breathing using the diaphragm.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Researcher will be applied progressive muscle relaxation and deep breathing exercises to the students in the experimental group. This practice will be applied to students once a week for six weeks. It will be ensured that the environment is quiet, at room temperature and dim. Students will take their places in chairs at an equal distance from each other. The researcher will be located in a place where his voice is heard by all students, and computers and speakers will be used for music. In addition, black eye patches will be distributed to students to use while exercising before starting the exercises. The muscle groups that are desired to be contracted and relaxed will be as follows (hands, arms, muscles in the face, tongue, head and neck muscles, shoulders, waist, abdominal leg muscles, and feet). At the same time, Lily's Theme which was selected by using the literature and expert opinion, will be played to the students together with the exercises. Receives: Behavioral: Progressive Muscle Relaxation and Breathing Exercises |
| Control Group | No intervention | No intervention will be applied to the control group. They will be expected to refill the scales at the end of six weeks and on the eighth week for follow-up purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
The Perceived Stress Scale for Nursing Students scale is used to determine the level of stress that nursing students perceive in their clinical practice experiences.
Measured: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).
Secondary outcomes (1)
Bio-psycho-social Response
The Bio-psycho-Social Response Scale for Nursing Students is used to determine the bio-psycho-social responses of nursing students to stress.
Measured: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start12 Nov 2022
- Primary completion23 Dec 2022
- Study completion6 Jan 2023
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 Saglik Bilimleri UniversitesiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparison of the two groups to be assigned as experimental and control groups will be made.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Çiğdem Yüksel, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008236
- Sponsor's protocol ID
- SBU-NK-01
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses to Stress
- ClinicalTrials.gov ID
- NCT06008236
- Acronym / sponsor ID
- SBU-NK-01
- Conditions
- Stress, Stress, Physiological
- Keywords
- Progressive muscle exercises, Breathing, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 23 Aug 2023 (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.
This clinical study will be conducted to determine the effects of musically accompanied progressive muscle relaxation and deep breathing exercises on nursing students' stress levels and bio-psycho-social responses to stress.
Do musical progressive muscle relaxation and deep breathing exercises have an impact on nursing students' stress levels and bio-psycho-social responses to stress?
After students fill in the scales, they will be randomly assigned to the experimental and control groups. The experimental group will be given progressive muscle relaxation and deep breathing exercises accompanied by music once a week for six weeks by the researcher. There will be no intervention in the control group. The scales will be reapplied to the experimental and control groups in the week after the application is completed and two weeks after the application is completed. Groups will be compared and statistical analyzes will be made.
Detailed description
Stress is a psychosocial factor that affects students' academic performance and well-being. The presence and level of stress have a positive or negative impact on learning and thinking, and students show behavioral, emotional, and physical symptoms of experiencing stress For this reason, it is very important for university students to apply stress reduction methods, especially non-drug methods. Progressive relaxation and deep breathing exercises with music are effective methods of coping with stress. When the literature is examined, it is seen that the use of music has recently been effective in reducing the anxiety and stress experienced by many students during the education process. At the same time, a progressive relaxation exercise integrated with deep breathing exercises helps a person to feel the difference between tension and laxity in the body and allows the person to learn to relax on their own, thus reducing physical and emotional tension. Thus, the individual moves away from disturbing stimuli that reduce the quality of life such as anxiety, pain, and stress. In accordance with the nursing education program carried out with theoretical and practical application course hours, students considering the stress they are exposed to and the behavioral, emotional, and physical problems that arise with stress, there is a need for research that uses mind-body applications to support nursing students. At the end of the research, it is foreseen that the stress levels of nursing students and the symptoms seen due to stress can be reduced.
Method: The universe of the study will consist of 2nd, 3rd, and 4th year nursing undergraduate students who are studying and interning at Gülhane Nursing Faculty of Health Sciences University in 2022-2023. As a result of the power analysis, the minimum sample size was found to be 140 students, with 70 students in each group. During the study, in order to strengthen the results of the research and increase reliability, it was determined that the sample was 154 students with 77 experiments and 77 control groups with an increase of at least 10%. Student sampling; After each class is evaluated as a layer, proportional stratification will be taken by sampling method according to layer weight (number of students). 44 students from 2nd grade, 52 students from 3rd grade, and 58 students from 4th grade will participate in the research. Students have completed the Voluntary Consent Form for Nursing Students, Personal Information Form, Perceived Stress, and Bio-psycho-social Response Scale, then students who meet the inclusion criteria will be randomly assigned to intervention and control groups. Exercises will be applied to the intervention groups for 6 weeks. There will be no intervention in the control group. At the end of 6 weeks and 2 weeks after the last application (8. Weeks) intervention and control groups will refill the scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A comparison of the two groups to be assigned as experimental and control groups will be made.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Progressive Muscle Relaxation and Breathing ExercisesResearcher will be applied progressive muscle relaxation and deep breathing exercises to the students in the experimental group. This practice will be applied to students once a week for six weeks. It will be ensured that the environment is quiet, at room temperature and dim. Students will take their places in chairs at an equal distance from each other. The researcher will be located in a place where his voice is heard by all students, and computers and speakers will be used for music. In addition, black eye patches will be distributed to students to use while exercising before starting the exercises. The muscle groups that are desired to be contracted and relaxed will be as follows (hands, arms, muscles in the face, tongue, head and neck muscles, shoulders, waist, abdominal leg muscles, and feet). At the same time, Lily's Theme which was selected by using the literature and expert opinion, will be played to the students together with the exercises. |
| Control Group | No intervention | –No intervention will be applied to the control group. They will be expected to refill the scales at the end of six weeks and on the eighth week for follow-up purposes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be a nursing student who is studying at Gulhane Nursing Faculty of Health Sciences University and going on internship
- Not to have any obstacles in oral and written communication in Turkish
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- If the student has a disease that prevents the relaxation exercise (Heart Failure, Musculoskeletal System Problem, etc.)
- The student is participating in another relaxation program
- The student is taking a psychiatric medication that has a relaxing effect
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 |
|---|---|---|
| Progressive Muscle Relaxation and Breathing ExercisesProgressive relaxation exercise is a method that provides relaxation in the whole body by voluntary, regular relaxation of large muscle groups in the human body. Exercise helps individuals to be able to feel the difference between tension in the muscles and relaxation, and to learn to relax on their own in case of tension. Deep breathing exercise supports the maximum ventilation of the lung by correct breathing using the diaphragm. | Behavioural | Experimental Group |
Primary outcome
Perceived Stress
Time frame: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).
The Perceived Stress Scale for Nursing Students scale is used to determine the level of stress that nursing students perceive in their clinical practice experiences.
1 secondary outcome
Bio-psycho-social Response
Time frame: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).
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 18 Mar 2024.
- 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.
Çiğdem Yüksel principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Breathing Exercises in people with Stress and Stress, Physiological, run by Saglik Bilimleri Universitesi 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 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: finished, as of the sponsor's last update on 18 Mar 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?
Perceived Stress (time frame: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).). 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 18 Mar 2024.