- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540172
The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice
September 4, 2020 updated by: Demet İnangil, PhD, Istanbul Saglik Bilimleri University
Music Therapy and Progressive Muscle Relaxation Exercise
This study was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This randomized controlled experimental study sample consisted of 86 nursing students who will be firstly applied to clinical practice.
The students were randomly assigned to music (n=30), exercise (n=28), and control (n=28) groups.
The data of the study were collected with Student Information Form and State-Trait Anxiety Scale.
The music therapy intervention was applied to the experimental groups three times a week for the first 2 weeks.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- 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
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Istanbul, Turkey, 34668
- Demet İnangil
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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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- being 18 years or older,
- being enrolled in the Nursing Fundamentals theoretical course,
- participating fully in the attempts being applied in the study,
- volunteering to participate in the study.
Exclusion Criteria:
- be graduating from Health Vocational High School
- not being in the field of application determined on the first clinical application day.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Music Therapy
music therapy was applied in the practice room.
Environmental noise was reduced as much as possible; the room was dimly lit.
The students were asked to close their eyes after sitting comfortably in a chair and focus on the music by asking them to imagine a different memory and place that would relax them instead of the thoughts that occupied their minds.
The music was played through a portable computer for 15 minutes under the supervision of the researchers using an mp3 player program on the computer.
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"Mahur tune," one of the nonverbal instruments of the Traditional Turkish Music Authorities, was selected for the study with the opinion of a music therapy specialist.
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EXPERIMENTAL: Progressive Muscle Relaxation Exercise
In this study, the steps of applying progressive muscle relaxation exercises were created with the guidance of the "Relaxation Exercises " materials of the Turkish Psychological Association.
Warning messages were hung on the door of the room, environmental noise was reduced as much as possible, and the room was provided with dim lighting.
The students were asked to close their eyes and breathe deeply after sitting comfortably in a chair.
After taking two deep breaths, they were told to dangle their arms and relax as much as possible.
The hands, shoulders, neck, chest, abdomen, hips, legs, feet, toes, and facial muscles were made to relax while they breathed and relaxed while exhaling.
They were asked to store the experience into their memories thoroughly so that they could recall this feeling for comfort during the day.
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In this study, the steps of applying progressive muscle relaxation exercise were created with the guidance of the "Relaxation Exercises " materials of the Turkish Psychological Association.
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NO_INTERVENTION: Control
No additional method was applied in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Change from baseline in 1 week
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The level of Anxiety was evaluated with the State-Trait Anxiety Inventory (STAI).
STAI consists of 20 items for assessing trait anxiety and 20 for state anxiety.
All items are rated on a 4-point scale (None" (1), "A little" (2), "Very" (3), and "Completely" (4).
Higher scores indicate greater anxiety.
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Change from baseline in 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Merdiye Şendir, PhD, Saglik Bilimleri University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dehghan-Nayeri N, Adib-Hajbaghery M. Effects of progressive relaxation on anxiety and quality of life in female students: a non-randomized controlled trial. Complement Ther Med. 2011 Aug;19(4):194-200. doi: 10.1016/j.ctim.2011.06.002. Epub 2011 Jul 12.
- Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.
- Inangil D, Sendir M, Kabuk A, Turkoglu I. The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice in Nursing Students: A Randomized Controlled Study. Florence Nightingale J Nurs. 2020 Oct 26;28(3):341-349. doi: 10.5152/FNJN.2020.19075. eCollection 2020 Oct.
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)
August 1, 2019
Primary Completion (ACTUAL)
October 1, 2019
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
September 4, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (ACTUAL)
September 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 4, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46418926
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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