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The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice

Primary Purpose

Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music Therapy
Progressive Muscle Relaxation Exercise
Sponsored by
Istanbul Saglik Bilimleri University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Demet İnangil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Music Therapy

Progressive Muscle Relaxation Exercise

Control

Arm Description

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.

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.

No additional method was applied in the control group.

Outcomes

Primary Outcome Measures

Anxiety
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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2020
Last Updated
September 4, 2020
Sponsor
Istanbul Saglik Bilimleri University
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1. Study Identification

Unique Protocol Identification Number
NCT04540172
Brief Title
The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice
Official Title
Music Therapy and Progressive Muscle Relaxation Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Saglik Bilimleri University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Progressive Muscle Relaxation Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No additional method was applied in the control group.
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
"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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
Change from baseline in 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merdiye Şendir, PhD
Organizational Affiliation
Saglik Bilimleri University
Official's Role
Study Chair
Facility Information:
Facility Name
Demet İnangil
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21827933
Citation
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.
Results Reference
background
PubMed Identifier
23260618
Citation
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.
Results Reference
background
PubMed Identifier
34263213
Citation
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.
Results Reference
derived

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The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice

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