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

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ClinicalTrials.gov Identifier: NCT01687907
Recruitment Status : Unknown
Verified September 2012 by Assi Sten, Helsinki University Central Hospital.
Recruitment status was:  Recruiting
First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Fear of Childbirth Behavioral: Music

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Longitudinal Trial About the Effects of Music on Fear of Childbirth and Outcome of Delivery
Study Start Date : October 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. spontaneous vaginal delivery [ Time Frame: day of delivery ]
    delivery data collected from the patient records afterwards


Secondary Outcome Measures :
  1. Delivery satisfaction [ Time Frame: within three days after delivery (before leaving the postpartum ward) ]
    specific questionnaires


Other Outcome Measures:
  1. early mother-infant relationship [ Time Frame: 6 months after delivery ]
    specific questionnaires

  2. mental wellbeing [ Time Frame: during pregnancy and up to 6 months after delivery ]
    specific questionnaires and diaries


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687907


Contacts
Contact: Assi Sten, MD +358504284700 assi.sten@helsinki.fi, assi.sten@hus.fi
Contact: Terhi Saisto, MD,PhD terhi.saisto@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, HUS, Finland, 00029
Contact: Assi Sten, MD    +358504284700    assi.sten@helsinki.fi, assi.sten@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Terhi Saisto, MD,PhD Helsinki University Central Hospital
Principal Investigator: Assi Sten, MD Helsinki University Central Hospital
More Information

Responsible Party: Assi Sten, Principal investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01687907     History of Changes
Other Study ID Numbers: 18/2.9.2009, 178/13/03/03/2009
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by Assi Sten, Helsinki University Central Hospital:
fear of childbirth
outcome of delivery
music
mother-baby relationship