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

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06010082
• Other study ID #: 69-D
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: August 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 20, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

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.

Locations

Country	Name	City	State
Egypt	Faculty of Nursing, Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression, Anxiety, and Stress Scale	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.	2 months
Primary	Sleep Quality	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.	2 months