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Massage Therapy Study: Massage Therapy and Labour Outcomes

NCT00611221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2011-04-27

No results posted yet for this study

Summary

OBJECTIVE: To measure the benefits of massage, administered by a registered massage therapist, to pain management for women in active labour.

DESIGN: A randomized controlled trial.

SETTING: BC Women's Hospital, a tertiary level maternity teaching hospital in Vancouver, British Columbia, Canada.

PARTICIPANTS: Healthy first time mothers experiencing an uncomplicated pregnancy who present to the hospital in labour. Seventy women will be enrolled in each trial arm.

MAIN OUTCOME MEASURES: The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion. Secondary outcomes include use of epidural and narcotic analgesia, and measures of intensity and characteristics of pain.

DATA ANALYSIS: Study outcomes will be compared among women randomized to receive a maximum of five hours of massage during labour administered by a registered massage therapist versus usual care. Analysis will be by intention to treat. Prognostics factors not balanced between trial arms (massage and usual care) will be controlled for in a multivariate analysis.

Conditions

  • Pain During Labour

Interventions

PROCEDURE

Massage

Massage therapy by an RMT during labour

PROCEDURE

Massage

Massage by anyone else, eg. husband, nurse, doula

Sponsors & Collaborators

  • Massage Therapy Foundation

    collaborator OTHER

  • Holistic Health Research

    collaborator UNKNOWN

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Patricia Janssen, Ph.D · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611221 on ClinicalTrials.gov