The Effects of Music on Fear of Childbirth and Outcome of Delivery (MUUSA)

September 15, 2012 updated by: Assi Sten, Helsinki University Central Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spontaneous vaginal delivery
Time Frame: day of delivery
delivery data collected from the patient records afterwards
day of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery satisfaction
Time Frame: within three days after delivery (before leaving the postpartum ward)
specific questionnaires
within three days after delivery (before leaving the postpartum ward)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
early mother-infant relationship
Time Frame: 6 months after delivery
specific questionnaires
6 months after delivery
mental wellbeing
Time Frame: during pregnancy and up to 6 months after delivery
specific questionnaires and diaries
during pregnancy and up to 6 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Terhi Saisto, MD,PhD, Helsinki University Central Hospital
  • Principal Investigator: Assi Sten, MD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 15, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 15, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18/2.9.2009, 178/13/03/03/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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