CClinicalTrials.gg
Status unknownNCT01687907MUUSAUpdated Sep 19, 2012

The Effects of Music on Fear of Childbirth and Outcome of Delivery

An interventional study of Music in Fear of Childbirth, sponsored by Helsinki University Central Hospital. Status unknown at 1 site in Finland. Open to female participants. Per ClinicalTrials.gov, last updated 2012-09-19.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Sex
Female
01

Study summary

The aim of this trial is to find out if active music listening during pregnancy and delivery reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if there is an effect on delivery complications. Also we try to find out if there is any influence on mother-baby relationship.

Read the detailed description

In Finland fear of childbirth is one of the common reasons for consultation of obstetrician and mother´s demand on elective caesarean section. Approximately 5-8% of pregnant women suffer from severe fear of childbirth, which disturbs their family-life and working and prevents normal preparation to childbirth and parenthood.

Listening or playing music is very common in all cultures. Even fetuses are able to hear and recognize music and babies are interested in voices and sounds of music.

Music therapy has been used in other purposes widely. It is known that music stimulates the synthesis of dopamine in brain and it has been shown that music has an influence on hypertensive rats, lowering their blood pressure. In human beings there has been pleasurable responses to music correlate with activity in brain. It has also been shown that music listening enhances cognitive recovery and mood after middle cerebral artery stroke.

A strong attachment between mother and infant is essential to child's normal developement. Mothers who suffer from very strong fear of childbirth often have difficulties in mother-infant relationship and pronounced risk of puerperal depression.

Many features in listening and playing music have something to do in bonding together in societies. Lullabies are good example of communication between parent and infant.

There has been some trials about music therapy and pregnancy but not systematic randomized trials about listening to music and its influence on pain experience, length of delivery or complications of delivery. Music has a relaxing influence on human beings and we assume that it has a positive influence on pregnant women also.

We try to find out if active listening to music has any influence on physical and mental wellbeing of pregnant women or is there any influence on fear of childbirth, outcome of delivery or mother-baby relationship.

Pregnant women referred to the outpatient clinic because of fear of childbirth have also normal appointments with obstetrician and/or midwife as needed and participating this trial has no influence on those appointments.

02

Conditions studied

  • Fear of Childbirth

Keywords

  • fear of childbirth
  • outcome of delivery
  • music
  • mother-baby relationship
03

In context

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • fear of childbirth in arms 1 and 2,
  • nulliparous in arms 3 and 4

Exclusion criteria

Exclusion Criteria:

  • not able to answer the questionnaires
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
800 participants (estimated)

Study arms

  • Active comparator
    Fear of childbirth, music

    Patients referred to the motherhood out-patient clinic because of fear of childbirth. Advised to active music listening. Followed up by weekly and monthly diaries and three questionnaires (when recruiting, just after the delivery and 6 months after the delivery).

    Behavioral: Music

  • No intervention
    Fear of childbirth, control

    Patients referred to the motherhood out-patient clinic because of fear of childbirth. No intervention. Followed up by three questionnaires (when recruiting, just after the delivery and 6 months after the delivery).

  • Active comparator
    Nulliparous, music

    300 nulliparous women recruited from the ultrasound screening. Advised to active music listening. Three questionnaires like the other arms, weekly and monthly diaries like the other music group. Screening questionnaires about fear of childbirth.

    Behavioral: Music

  • No intervention
    Nulliparous, control

    300 nulliparous women recruited from ultrasound screening. No intervention. 3 Questionnaires as all the other groups. Screening questionnaire about fear of childbirth.

Interventions

  • BehavioralMusic
06

What researchers measure

Primary outcomes

  1. spontaneous vaginal delivery

    delivery data collected from the patient records afterwards

    Time frame: day of delivery

Secondary outcomes

  1. Delivery satisfaction

    specific questionnaires

    Time frame: within three days after delivery (before leaving the postpartum ward)

Other outcomes

  1. early mother-infant relationship

    specific questionnaires

    Time frame: 6 months after delivery

  2. mental wellbeing

    specific questionnaires and diaries

    Time frame: during pregnancy and up to 6 months after delivery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2. PubMed 34231203 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01687907
Lead sponsor
Helsinki University Central Hospital
Responsible party
Assi Sten (Principal investigator, Helsinki University Central Hospital) — Principal investigator
First posted
Sep 19, 2012
Start date
Oct 2009
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Sep 19, 2012

Study contacts

Assi Sten, MD
Contact
assi.sten@helsinki.fi, assi.sten@hus.fi
+358504284700
Terhi Saisto, MD,PhD
Contact
terhi.saisto@hus.fi
Terhi Saisto, MD,PhD
study director · Helsinki University Central Hospital
Assi Sten, MD
principal investigator · Helsinki University Central Hospital
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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