Treating Pregnancy Related Insomnia With Music

• ClinicalTrials.gov Identifier: NCT04633395
• Recruitment Status: Recruiting
• First Posted: November 18, 2020
• Last Update Posted: September 29, 2021
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Related; Sleep Disturbance; Insomnia	Other: Music; Behavioral: Sleep hygiene	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: July 30, 2022
• Estimated Study Completion Date: July 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Sleep quality [ Time Frame: 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 ]
   Pittsburgh Sleep Quality Index. Scoring from 0-21 with higher numbers meaning more severe sleep problems. Cut-off score at 5.
2. Sleep quality - insomnia symptoms [ Time Frame: 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 ]
   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).

Secondary Outcome Measures :

1. Depressive symptoms [ Time Frame: 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 ]
   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.
2. Stress [ Time Frame: 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 ]
   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.
3. Pre-sleep arousal [ Time Frame: 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 ]
   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.
4. Prenatal attachment [ Time Frame: 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 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.
5. Anxiety [ Time Frame: 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 ]
   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.
6. Postpartum bonding [ Time Frame: Between group differences at follow up, up to 3 months postpartum ]
   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
7. Childbirth experience [ Time Frame: Between group differences at follow up, up to 3 months postpartum ]
   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

Other Outcome Measures:

1. Sleep apnea [ Time Frame: Pre- and post treatment (at the end date of the 4 week intervention) measurements to ensure the participant has not developed 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.
2. Music reward [ Time Frame: Baseline measurement only. ]
   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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Nadia F Hoegholt, MD; 20513767 ext 0045; nadiafh@clin.au.dk

Contact: Kira V Jespersen, PhD; kira@clin.au.dk

Locations

Denmark

Center for Music In the Brain, Aarhus University; Recruiting

Aarhus, Denmark, 8000

Contact: Nadia Hoegholt, MD 004520513767 nadiafh@clin.au.dk

Sponsors and Collaborators

University of Aarhus

Investigators

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

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04633395
• Other Study ID Numbers: Caregiving+
• First Posted: November 18, 2020
• Last Update Posted: September 29, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:

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

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders