Treating Pregnancy Related Insomnia With Music
- Conditions
- Pregnancy RelatedSleep DisturbanceInsomnia
- Registration Number
- NCT04633395
- Lead Sponsor
- University of Aarhus
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 106
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sleep quality 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.
Sleep quality - insomnia 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 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
Name Time Method 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 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.
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 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.
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 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.
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 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.
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 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.
Postpartum bonding 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
Childbirth experience 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
Trial Locations
- Locations (1)
Center for Music In the Brain, Aarhus University
🇩🇰Aarhus, Denmark
Center for Music In the Brain, Aarhus University🇩🇰Aarhus, Denmark