Treating Pregnancy Related Insomnia With Music

Insomnia Clinical Trial

Official title:

Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633395
• Other study ID #: Caregiving+
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Pregnancy Related
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	Center for Music In the Brain, Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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