The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT06010082

Collaborator

(none)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a strong correlation between sleep disturbance and indications of stress, anxiety, and depression. However, in Egypt no research has looked into how better sleep for expectant mothers might be achieved by inexpensive, pleasurable, non-invasive music listening. Therefore, the aim of this study was to investigate how music listening affects pregnant women's psychological status, and sleep quality.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women	Behavioral: Music Therapy	N/A

Detailed Description

This study used a randomized controlled trial (RCT) design and adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study utilized a simple random sampling technique to select participants in proportion to the total number of pregnant women in the outpatient Medical National Institute in Damanhur city, Egypt.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women: A Randomized Control Trail

Actual Study Start Date :

Feb 1, 2023

Actual Primary Completion Date :

Jul 15, 2023

Actual Study Completion Date :

Aug 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STUDY GROUP Intervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.	Behavioral: Music Therapy Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.
Active Comparator: Control group Group two(the control group, 40 pregnant women):act as a control group/ waiting list	Behavioral: Music Therapy Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.

Arm

Intervention/Treatment

Experimental: STUDY GROUP

Intervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.

Behavioral: Music Therapy

Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.

Active Comparator: Control group

Group two(the control group, 40 pregnant women):act as a control group/ waiting list

Behavioral: Music Therapy

Outcome Measures

Primary Outcome Measures

Depression, Anxiety, and Stress Scale [2 months]
The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.
Sleep Quality [2 months]
It is a standardized self-report instrument used to measure the quality and patterns of sleep during the past month. It was developed and validated by Buysse et al. in 1989. It has 9 questions. Question number 5 contains 10 sub-items (from 5a to 5j). All questions are combined to form 7 components. Scoring of answers ranged from zero to three.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

In third trimester, 30-34th weeks of pregnancy, age ranging from 18-35 years old, singleton pregnancy, willing to participate

Exclusion Criteria:

having any physical or mental health disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Nursing, Alexandria university	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud Khedr, Lecturer, Alexandria University

ClinicalTrials.gov Identifier:

NCT06010082

Other Study ID Numbers:

69-D

First Posted:

Aug 24, 2023

Last Update Posted:

Aug 24, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 24, 2023