NCT04987957

Brief Summary

This study, which has a randomized controlled experimental design, was planned to determine the effect of music therapy on the anxiety level of family health personnel working in primary health care centers during the COVID-19 pandemic. The study will be carried out between 4 August and 31 December with nurses, midwives and other family health personnel working in family health centers. Participants will be randomized into two groups, a control and an intervention group. Individuals in the intervention group will receive 15 minutes of music therapy once a day for 5 days. No intervention will be made in the control group. Data Descriptive Question and State-Trait Anxiety Inventory online design; It will be collected on the Google Forms platform.. Data analysis will be done using SPSS 20 program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
8mo left

Started Dec 2021

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Dec 2021Dec 2026

First Submitted

Initial submission to the registry

July 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

4.2 years

First QC Date

July 30, 2021

Last Update Submit

December 16, 2023

Conditions

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    State-Trait Anxiety Scale The scale consists of a total of 40 items in two separate parts. The scale includes direct and reversed statements. The total score that can be obtained from the scale is a minimum of 20 and a maximum of 80 points, and an increase in the score indicates an increase in the level of anxiety (Öner and Le Compte 1983).

    Two months

Study Arms (2)

Experimental group

EXPERIMENTAL

4 music genres with expert opinion will be presented to the preference of the participants in the intervention group, these types of music; Classical Music, Turkish Classical Music, Turkish Folk Music and Sufi Music. The music is instrumental, 70 decibels and non-verbal. Participants will listen to a genre they choose and download to their mobile phones once for 5 days for 15 minutes. They will listen to the music in the environment they live in, at a time convenient for them, at the desired volume level and with headphones in accordance with the determined therapy program. At the beginning of the research, an Introductory Questionnaire will be applied to all participants. Trait Anxiety Inventory will be administered before music therapy on the 1st day of the study and after the music therapy application on the 5th day.

Other: Music Therapy

Control group

NO INTERVENTION

No application will be made to the participants in the control group, and the data collection tools will be applied with the same frequency as in the intervention group.

Interventions

Classical Music, Turkish Classical Music, Turkish Folk Music and Sufi Music

Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Not having a verbal or auditory communication barrier,
  • To voluntarily agree to participate in the research,
  • Not having a diagnosis of neuropsychiatric disease,
  • Having the opportunity to fill out the surveys online,
  • Possess the title of midwife or nurse.

You may not qualify if:

  • Having a diagnosed neuropsychiatric disorder,
  • Verbal and auditory communication disability,
  • Not being willing to participate in the research,
  • Having a title other than a midwife or nurse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Centers in Bolu

Bolu, Turkey (Türkiye)

RECRUITING

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

  • Saadet Can Çiçek

    http://www.ibu.edu.tr/tr

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The sample groups of the research will be divided into two groups as experiment and intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffessor

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 3, 2021

Study Start

December 8, 2021

Primary Completion

January 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 19, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations