Pregnancy RelatedNCT04633395
Treating Pregnancy Related Insomnia With Music
A study testing Music and Sleep hygiene in people with Pregnancy Related and Sleep Disturbance, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Sleep Disturbance, Insomnia
- What is being tested?
- Music and Sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2020to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial
This study aims to examine the effects of 4 weeks music listening at bedtime on sleep quality during the third trimester of pregnancy.
Read the 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).
- Conditions
- Pregnancy Related, Sleep Disturbance, Insomnia
- Being tested
- Music, Sleep hygiene
- Keywords
- Music, Sleep, Insomnia, Non-pharmaceutic, Sleep disturbances
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
The participant can choose between 5 different soothing playlists
Sleep hygieneBehavioural
These are behavioural guidelines to help establish a better sleep pattern
| Study group | Role | What they receive |
|---|---|---|
| Music before bedtime | Experimental | 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. Receives: Other: Music; Behavioral: Sleep hygiene |
| Sleep hygiene | Active comparator | Participants will be given sleep hygiene guidelines, and be asked to follow these during the total treatment period of 4 weeks. Receives: Behavioral: Sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Pittsburgh Sleep Quality Index. Scoring from 0-21 with higher numbers meaning more severe sleep problems. Cut-off score at 5.
Measured: 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).
Measured: 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 (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Between group differences at follow up, up to 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Dec 2020
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten L Kringelbach, Professor, Principal investigator, Aarhus University anf University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633395
- Sponsor's protocol ID
- Caregiving+
- Status last verified
- May 2022
- First submitted
- 3 Nov 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoegholt NF, Kraenge CE, Vuust P, Kringelbach M, Jespersen KV. Music and Sleep Hygiene Interventions for Pregnancy-Related Insomnia: An Online Randomized Controlled Trial. J Midwifery Womens Health. 2025 May-Jun;70(3):387-395. doi: 10.1111/jmwh.13699. Epub 2024 Oct 17.
PubMed 39417384Jespersen 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.
PubMed 36000763
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04633395
- Acronym / sponsor ID
- Caregiving+
- Conditions
- Pregnancy Related, Sleep Disturbance, Insomnia
- Keywords
- Music, Sleep, Insomnia, Non-pharmaceutic, Sleep disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pregnant women in the third trimester will be randomised to 2 different groups (intervention group, and active control group).
| Arm | Type | Receives |
|---|---|---|
| Music before bedtime | Experimental | Other: Music, Behavioral: Sleep hygieneParticipants 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. |
| Sleep hygiene | Active comparator | Behavioral: Sleep hygieneParticipants will be given sleep hygiene guidelines, and be asked to follow these during the total treatment period of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicThe participant can choose between 5 different soothing playlists | Other | Music before bedtime |
| Sleep hygieneThese are behavioural guidelines to help establish a better sleep pattern | Behavioural | Music before bedtime, Sleep hygiene |
Primary outcome
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.
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).
7 secondary outcomes
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
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
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
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
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
Postpartum bonding
Time frame: Between group differences at follow up, up to 3 months postpartum
Childbirth experience
Time frame: Between group differences at follow up, up to 3 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 39417384Hoegholt NF, Kraenge CE, Vuust P, Kringelbach M, Jespersen KV. Music and Sleep Hygiene Interventions for Pregnancy-Related Insomnia: An Online Randomized Controlled Trial. J Midwifery Womens Health. 2025 May-Jun;70(3):387-395. doi: 10.1111/jmwh.13699. Epub 2024 Oct 17.
- Derived from this study: PubMed 36000763Jespersen 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten L Kringelbach, Professor principal investigator
Aarhus University anf University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Sleep hygiene in people with Pregnancy Related and Sleep Disturbance, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633395, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.