NCT01687907

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

6.2 years

First QC Date

September 10, 2012

Last Update Submit

September 15, 2012

Conditions

Fear of Childbirth

Keywords

fear of childbirthoutcome of deliverymusicmother-baby relationship

Outcome Measures

Primary Outcomes (1)

  • spontaneous vaginal delivery

    delivery data collected from the patient records afterwards

    day of delivery

Secondary Outcomes (1)

  • Delivery satisfaction

    within three days after delivery (before leaving the postpartum ward)

Other Outcomes (2)

  • early mother-infant relationship

    6 months after delivery

  • mental wellbeing

    during pregnancy and up to 6 months after delivery

Study Arms (4)

Fear of childbirth, music

ACTIVE COMPARATOR

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

Fear of childbirth, control

NO INTERVENTION

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).

Nulliparous, music

ACTIVE COMPARATOR

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

Nulliparous, control

NO INTERVENTION

300 nulliparous women recruited from ultrasound screening. No intervention. 3 Questionnaires as all the other groups. Screening questionnaire about fear of childbirth.

Interventions

MusicBEHAVIORAL
Fear of childbirth, musicNulliparous, music

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not able to answer the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34231203DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Terhi Saisto, MD,PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Assi Sten, MD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Assi Sten, MD

CONTACT

+358504284700assi.sten@helsinki.fi, assi.sten@hus.fi

Terhi Saisto, MD,PhD

CONTACT

terhi.saisto@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 19, 2012

Study Start

October 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

FI(1)