Clinical trial NCT01687907: The Effects of Music on Fear of Childbirth and Outcome of Delivery
Official title: A Randomized Longitudinal Trial About the Effects of Music on Fear of Childbirth and Outcome of Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fear of Childbirth
Keywords: fear of childbirth
outcome of delivery
music
mother-baby relationship
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* not able to answer the questionnaires

Primary outcomes:
measure: spontaneous vaginal delivery
timeFrame: day of delivery
Secondary outcomes:
measure: Delivery satisfaction
timeFrame: within three days after delivery (before leaving the postpartum ward)
Other outcomes:
measure: early mother-infant relationship
timeFrame: 6 months after delivery
measure: mental wellbeing
timeFrame: during pregnancy and up to 6 months after delivery
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: HUS
Study officials:
affiliation: Helsinki University Central Hospital
name: Terhi Saisto, MD,PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Assi Sten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.