Treating Pregnancy Related Insomnia With Music

Study Overview
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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).

Official Title
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Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial

Conditions
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Pregnancy Related, Sleep Disturbance, Insomnia

Intervention / Treatment
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* Other: Music
* Behavioral: Sleep hygiene


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music, Sleep, Insomnia, Non-pharmaceutic, Sleep disturbances