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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06010082
Other study ID # 69-D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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