The Effect of Progressive Relaxation and Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses

March 15, 2024 updated by: Saglik Bilimleri Universitesi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 68105
        • Saglık Bilimleri University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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.
Behavioral: Progressive Muscle Relaxation and Breathing Exercises
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.
No Intervention: Control Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
The Bio-psycho-Social Response Scale for Nursing Students is used to determine the bio-psycho-social responses of nursing students to stress.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Çiğdem Yüksel, Saglık Bilimleri University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBU-NK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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