NCT04540172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 4, 2020

Last Update Submit

September 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline in 1 week

Study Arms (3)

Music Therapy

EXPERIMENTAL

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.

Behavioral: Music Therapy

Progressive Muscle Relaxation Exercise

EXPERIMENTAL

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.

Behavioral: Progressive Muscle Relaxation Exercise

Control

NO INTERVENTION

No additional method was applied in the control group.

Interventions

Music TherapyBEHAVIORAL

"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.

Music Therapy

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.

Progressive Muscle Relaxation Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • be graduating from Health Vocational High School
  • not being in the field of application determined on the first clinical application day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demet İnangil

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 21827933BACKGROUND
  • 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.

    PMID: 23260618BACKGROUND
  • 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.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Merdiye Şendir, PhD

    Saglik Bilimleri University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 7, 2020

Study Start

August 1, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations