- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687907
The Effects of Music on Fear of Childbirth and Outcome of Delivery (MUUSA)
A Randomized Longitudinal Trial About the Effects of Music on Fear of Childbirth and Outcome of Delivery
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Assi Sten, MD
- Phone Number: +358504284700
- Email: assi.sten@helsinki.fi, assi.sten@hus.fi
Study Contact Backup
- Name: Terhi Saisto, MD,PhD
- Email: terhi.saisto@hus.fi
Study Locations
-
-
HUS
-
Helsinki, HUS, Finland, 00029
- Recruiting
- Helsinki University Central Hospital
-
Contact:
- Assi Sten, MD
- Phone Number: +358504284700
- Email: assi.sten@helsinki.fi, assi.sten@hus.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
|
|
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.
|
|
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
Investigators
- Study Director: Terhi Saisto, MD,PhD, Helsinki University Central Hospital
- Principal Investigator: Assi Sten, MD, Helsinki University Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Clinical Trials on Fear of Childbirth
-
University of Las Palmas de Gran CanariaServicio Canario de SaludCompleted
-
Marmara UniversityCompleted
-
Marmara UniversityNot yet recruitingFear of ChildbirthTurkey
-
Marmara UniversityCompletedFear of ChildbirthTurkey
-
Ankara City Hospital BilkentCompleted
-
Taipei Medical UniversityCompleted
-
Helsinki University Central HospitalCompletedFear of ChildbirthFinland
-
Helsingborgs HospitalUnknown
-
Cukurova UniversityCompletedPregnancy | Fear | Education | Fear of Childbirth | BirthTurkey
-
Uppsala UniversityUniversity of Melbourne; Mid Sweden UniversityCompleted
Clinical Trials on Music
-
Azad University of Medical SciencesCompleted
-
Ankara Diskapi Training and Research HospitalCompleted
-
The University of Texas Health Science Center at...Active, not recruiting
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Corporacion Parc TauliRecruitingDistal Radius Fracture ReductionSpain
-
Ankara Diskapi Training and Research HospitalCompleted
-
University Hospital, LimogesUnknown
-
Western University, CanadaNot yet recruitingPatient Satisfaction
-
Christiana Care Health ServicesCompleted