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Massage Therapy Study: Massage Therapy and Labour Outcomes

This study has been completed.
Sponsor:
Collaborators:
Massage Therapy Foundation
Holistic Health Research
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00611221
First received: January 28, 2008
Last updated: April 26, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain During Labour
 Procedure: Massage
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Massage Therapy and Labour Outcomes; A Randomized Controlled Trial

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion. [ Time Frame: During labour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes include use of epidural and narcotic analgesia and measures of intensity and characteristics of pain. [ Time Frame: During labour ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Massage therapy by a regulated massage therapist
 Procedure: Massage
Massage therapy by an RMT during labour
Active Comparator: 2
Massage by anyone else, eg. husband, nurse, doula
 Procedure: Massage
Massage by anyone else, eg. husband, nurse, doula

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy primiparous women
  • Nulliparous
  • Singleton gestation
  • Cephalic presentation
  • Term gestation (37-41 completed weeks of pregnancy)
  • Maternal age between 18 and 35 years of age
  • In spontaneous labour, defined for our purposes as painful contractions which have resulted in cervical change, i.e. cervix is 1 cm dilated or more with effacement at 25% (0.5 cm) or more on admission to the labour unit
  • Able to speak and read English or speak a language for which there is a nursing interpreter available

Exclusion Criteria

  • Pre-existing medical conditions including but not limited to: insulin dependent diabetes, renal, cardiac, or thyroid conditions, hypertension, epilepsy, psychosis, use of illicit street drugs
  • Conditions arising during pregnancy which require non-routine surveillance and/or intervention including but not limited to gestational diabetes, gestational hypertension, 2nd or 3rd trimester hemorrhage, intrauterine growth restriction, presence of a fetal congenital anomaly, history of preterm prelabour rupture of membranes
  • Statement by women on admission that she has been in labour for more than 24 hours
  • Cervical dilatation 10 cm (full dilatation) on admission to the labour ward
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611221

Locations
Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Massage Therapy Foundation
Holistic Health Research
Investigators
Principal Investigator: Patricia Janssen, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: Patricia Janssen, University of British Columbia
ClinicalTrials.gov Identifier: NCT00611221     History of Changes
Other Study ID Numbers: H07-00528, CW07-0090
Study First Received: January 28, 2008
Last Updated: April 26, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
massage
labour

ClinicalTrials.gov processed this record on May 16, 2013