Treating Pregnancy Related Insomnia With Music

NCT04633395 | Completed

• 1 other identifier: Caregiving+
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related; Sleep Disturbance; Insomnia

Keywords

Music; Sleep; Insomnia; Non-pharmaceutic; Sleep disturbances

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  Pittsburgh Sleep Quality Index. Scoring from 0-21 with higher numbers meaning more severe sleep problems. Cut-off score at 5.

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

• Sleep quality - insomnia symptoms

  Insomnia Severity Index. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

Secondary Outcomes (7)

• Depressive symptoms

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

• Stress

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

• Pre-sleep arousal

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

• Prenatal attachment

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

• Anxiety

  Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum

Other Outcomes (2)

• Sleep apnea

  Pre- and post treatment (at the end date of the 4 week intervention) measurements to ensure the participant has not developed sleep apnea

• Music reward

  Baseline measurement only.

Study Arms (2)

Music before bedtime

EXPERIMENTAL

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.

Other: Music; Behavioral: Sleep hygiene

Sleep hygiene

ACTIVE COMPARATOR

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

Behavioral: Sleep hygiene

Interventions

Music OTHER

The participant can choose between 5 different soothing playlists

Music before bedtime

Sleep hygiene BEHAVIORAL

These are behavioural guidelines to help establish a better sleep pattern

Music before bedtime; Sleep hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Center for Music In the Brain, Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 39417384 DERIVED

• 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.

  PMID: 36000763 DERIVED

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Morten L Kringelbach, Professor

  Aarhus University anf University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 18, 2020
• Study Start: December 1, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)