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

Fear of Childbirth Clinical Trial

— MUUSA  

Official title:

A Randomized Longitudinal Trial About the Effects of Music on Fear of Childbirth and Outcome of Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01687907
• Other study ID #: 18/2.9.2009, 178/13/03/03/2009
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2012
• Last updated: September 15, 2012
• Start date: October 2009
• Est. completion date: December 2015

Study information

• Verified date: September 2012
• Source: Helsinki University Central Hospital
• Contact: Assi Sten, MD
• Phone: +358504284700
• Email: assi.sten[@]helsinki.fi, assi.sten[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• fear of childbirth in arms 1 and 2,

• nulliparous in arms 3 and 4

Exclusion Criteria:

• not able to answer the questionnaires

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fear of Childbirth

Intervention

Behavioral:
• Music

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	early mother-infant relationship	specific questionnaires	6 months after delivery	No
Other	mental wellbeing	specific questionnaires and diaries	during pregnancy and up to 6 months after delivery	No
Primary	spontaneous vaginal delivery	delivery data collected from the patient records afterwards	day of delivery	No
Secondary	Delivery satisfaction	specific questionnaires	within three days after delivery (before leaving the postpartum ward)	No