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

Not Applicable

Completed

• Conditions: Pregnant Women
• Interventions: Behavioral: Music Therapy

• Registration Number: NCT06010082
• Lead Sponsor: Alexandria University

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.

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 Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-07-15
• Status Verified: 2023-08
• Study Completion: 2023-08-20
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Music Therapy	Group two(the control group, 40 pregnant women):act as a control group/ waiting list
STUDY GROUP	Music Therapy	Intervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Nursing, Alexandria university; 🇪🇬 Alexandria, Egypt