The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2023
CompletedFirst Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 24, 2023
CompletedAugust 24, 2023
August 1, 2023
5 months
August 21, 2023
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
STUDY GROUP
EXPERIMENTALIntervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.
Control group
ACTIVE COMPARATORGroup two(the control group, 40 pregnant women):act as a control group/ waiting list
Interventions
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.
Eligibility Criteria
You may qualify if:
- In third trimester, 30-34th weeks of pregnancy, age ranging from 18-35 years old, singleton pregnancy, willing to participate
You may not qualify if:
- having any physical or mental health disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Nursing, Alexandria university
Alexandria, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
August 21, 2023
First Posted
August 24, 2023
Study Start
February 1, 2023
Primary Completion
July 15, 2023
Study Completion
August 20, 2023
Last Updated
August 24, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share