Treating Pregnancy Related Insomnia With Music

Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial

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

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Disturbance; Pregnancy Related
• Intervention / Treatment: Other: Music; Behavioral: Sleep hygiene

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Center for Music In the Brain, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Music; The participant can choose between 5 different soothing playlists; Behavioral: Sleep hygiene; These are behavioural guidelines to help establish a better sleep pattern
Active Comparator: Sleep hygiene; Participants will be given sleep hygiene guidelines, and be asked to follow these during the total treatment period of 4 weeks.	Behavioral: Sleep hygiene; These are behavioural guidelines to help establish a better sleep pattern

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Edinburgh Postnatal Depression Scale. Maximum score of 30, and minimum of 0. The higher the score, the more severe the symptoms. A Danish cut-off score at 11 is used.	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	Perceived Stress Scale. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived 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	The Pre-Sleep Arousal Scale (PSAS) contains 16 items with eight symptoms of cognitive (e.g., intrusive thoughts) and eight symptoms of somatic (e.g., sweating) arousal experienced at bed- time. A total score from 8 to 40 is computed for both subscales with higher scores indicating higher 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	Prenatal attachment Inventory. It consists of 21 Likert-type items with a 4-point response scale (1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). Total scores can range from 21 to 84, with high scores indicating higher levels of 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	State- Trait Anxiety Inventory. It consists of two subtests - trait and state anxiety. Range of scores for each subtest is 20-80, the higher score indicating greater 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
Postpartum bonding	Postpartum Bonding Questionnaire. The PBQ consists of 25 statements about mothers' feelings, where mothers answer how well the statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems. Min. score: 0, Max score: 125	Between group differences at follow up, up to 3 months postpartum
Childbirth experience	Childbirth Experience Questionnaire. For 19 of the items the response format is a 4-point Likert Scale whereas the last three items use a visual analogue scale (VAS). The scoring range is 1 to 4 where higher ratings reflect more positive experiences. Min = 22. Max = 88	Between group differences at follow up, up to 3 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep apnea	Epworth Sleepiness Scale. 8 items scored from 0-3. Interpretation: 0-5 lower normal daytime sleepiness. 6-10 normal daytime sleepiness. 11-12 mild excessive daytime symptoms. 13-15 moderate excessive daytime symptoms. 16-24 severe excessive daytime symptoms.	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	Barcelona Music Reward Questionnaire. The BMRQ is a 20-item questionnaire that examines five main facets that characterize musical reward experience in individuals: musical seeking, emotion evocation, mood regulation, social reward and sensory-motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from "fully disagree" (1) to "fully agree" (5). The contribution of each facet to the overall music reward experience is quantified by a numerical value obtained upon completion of the survey. A score for global sensitivity to music reward is also provided, which was obtained as the weighted sum of participants' scores (i.e., factor score). The mean value of each factor is 50, and the standard deviation is 10. Standard values are therefore located between 40 and 60. Punctuations below 40 indicate low values in this particular facet, whereas values above 60 indicate high values (the same applies to the global sensitivity to music reward)	Baseline measurement only.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Morten L Kringelbach, Professor, Aarhus University anf University of Oxford

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Music; Sleep disturbances; Non-pharmaceutic
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: Caregiving+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No