Clinical trial NCT04633395: Treating Pregnancy Related Insomnia With Music
Official title: Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Sleep Disturbance
Insomnia
Keywords: Music
Sleep
Insomnia
Non-pharmaceutic
Sleep disturbances
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Sleep quality
timeFrame: 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
measure: Sleep quality - insomnia symptoms
timeFrame: 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 outcomes:
measure: Depressive symptoms
timeFrame: 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
measure: Stress
timeFrame: 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
measure: Pre-sleep arousal
timeFrame: 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
measure: Prenatal attachment
timeFrame: 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
measure: Anxiety
timeFrame: 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
measure: Postpartum bonding
timeFrame: Between group differences at follow up, up to 3 months postpartum
measure: Childbirth experience
timeFrame: Between group differences at follow up, up to 3 months postpartum
Other outcomes:
measure: Sleep apnea
timeFrame: Pre- and post treatment (at the end date of the 4 week intervention) measurements to ensure the participant has not developed sleep apnea
measure: Music reward
timeFrame: Baseline measurement only.
Locations:
city: Aarhus
country: Denmark
facility: Center for Music In the Brain, Aarhus University
Study officials:
affiliation: Aarhus University anf University of Oxford
name: Morten L Kringelbach, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.