Massage for Pain Relief During the Active Phase of Labor
Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor
1 other identifier
interventional
46
1 country
1
Brief Summary
The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Sep 2009
Typical duration for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedResults Posted
Study results publicly available
March 5, 2015
CompletedMarch 5, 2015
February 1, 2015
1 year
July 11, 2011
May 16, 2012
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of Massage Therapy in Pain Relief During Labor.
The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.
30 minutes
Secondary Outcomes (6)
Pharmacological Analgesia Request According to the Cervical Dilation.
10 hours
Obstetric Outcomes - Delivery
10 hours
Obstetric Outcomes - Duration of Labour
10 hours
Obstetric Outcome - Moment of Corioamniorrhexis
10 hours
Obstetric Outcomes - Moment of Utilization of Oxytocin
10 hours
- +1 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONControl Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
Massage Group
EXPERIMENTALMassage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Interventions
Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
Eligibility Criteria
You may qualify if:
- Nulliparous
- literate
- A single fetus in vertex position
- Low-risk Pregnancy
- From 37 weeks of gestation
- Cervical dilatation from 4 cm with normal uterine dynamics in this phase
- Labor in early spontaneous
- No use of medications during the study period
- Absence of cognitive or psychiatric problems
- Intact membranes
- No risk factors associated
- You want to participate and signing the informed consent
You may not qualify if:
- Use of drugs or any procedure that aims to relieve pain
- Intolerance to the application of massage therapy
- Presence of dermatological conditions that indicate against the application of massage therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Referral center for women's health Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900, Brazil
Related Publications (1)
Chang MY, Wang SY, Chen CH. Effects of massage on pain and anxiety during labour: a randomized controlled trial in Taiwan. J Adv Nurs. 2002 Apr;38(1):68-73. doi: 10.1046/j.1365-2648.2002.02147.x.
PMID: 11895532RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The influence of the pain of other women in labor or under the effect of childbirth analgesia; Accompanying with no physical or emotional preparation; Brazilian culture, which associates pain with suffering.
Results Point of Contact
- Title
- Prof Silvana Quintana
- Organization
- Universidade de São Paulo
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 12, 2011
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Study Completion
July 1, 2011
Last Updated
March 5, 2015
Results First Posted
March 5, 2015
Record last verified: 2015-02