Treating Pregnancy Related Insomnia With Music

NCT ID: NCT04633395

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-08-30

Brief Summary

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This study aims to examine the effects of 4 weeks music listening at bedtime on sleep quality during the third trimester of pregnancy.

Detailed Description

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50-60% of pregnant women suffer from insomnia during pregnancy. Pregnancy-related insomnia is often neglected due to a lack of suitable and safe treatments. This study aims to evaluate the effectiveness of music compared to sleep hygiene on sleep quality in a population of first-time pregnant women in the final stages of pregnancy. A post pregnancy follow-up will be completed to test if potential effects of the treatment might last into early motherhood (1-3 months postpartum).

Conditions

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Pregnancy Related Sleep Disturbance Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Music before bedtime

Participants will be listening to music before bedtime for a duration of up to 1 hour each night, in a total treatment period of 4 weeks. Participants will also receive the sleep hygiene guidelines, and be told to follow these.

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

The participant can choose between 5 different soothing playlists

Sleep hygiene

Intervention Type BEHAVIORAL

These are behavioural guidelines to help establish a better sleep pattern

Sleep hygiene

Participants will be given sleep hygiene guidelines, and be asked to follow these during the total treatment period of 4 weeks.

Group Type ACTIVE_COMPARATOR

Sleep hygiene

Intervention Type BEHAVIORAL

These are behavioural guidelines to help establish a better sleep pattern

Interventions

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Music

The participant can choose between 5 different soothing playlists

Intervention Type OTHER

Sleep hygiene

These are behavioural guidelines to help establish a better sleep pattern

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female, aged 18 years or above, pregnant non-mothers
* Have a sufficient level of Danish (verbal) to understand and respond to the questions and task instructions
* Pregnant women will be enrolled in gestation week 29.

Exclusion Criteria

* Postnatal depression, i.e. a score of 12 or above on the EPDS questionnaire
* Comorbid psychiatric disorder (i.e. epilepsy and depression)
* Using sleep medication
* Working more than two night shifts per week
* History of sleep disorders
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morten L Kringelbach, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University anf University of Oxford

Locations

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Center for Music In the Brain, Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Hoegholt NF, Kraenge CE, Vuust P, Kringelbach M, Jespersen KV. Music and Sleep Hygiene Interventions for Pregnancy-Related Insomnia: An Online Randomized Controlled Trial. J Midwifery Womens Health. 2025 May-Jun;70(3):387-395. doi: 10.1111/jmwh.13699. Epub 2024 Oct 17.

Reference Type DERIVED
PMID: 39417384 (View on PubMed)

Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.

Reference Type DERIVED
PMID: 36000763 (View on PubMed)

Other Identifiers

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Caregiving+

Identifier Type: -

Identifier Source: org_study_id

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