NCT06010082

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 21, 2023

Last Update Submit

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

EXPERIMENTAL

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

Behavioral: Music Therapy

Control group

ACTIVE COMPARATOR

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

Behavioral: Music Therapy

Interventions

Music TherapyBEHAVIORAL

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.

Control groupSTUDY GROUP

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

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

Locations