Massage for Pain Relief During the Active Phase of Labor

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01392053
First received: July 11, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pain
Other: Lumbosacral Massage
Other: Routine Procedures of Motherhood
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Evaluate the effectiveness of massage therapy pain relief during labor. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    To assess the efficacy of massage therapy as a resource for pain relief during the active phase of labor.


Secondary Outcome Measures:
  • The massage therapy postpones the use pharmacological pain relief. [ Time Frame: 10 hours ] [ Designated as safety issue: Yes ]
    Consider whether massage therapy during the active phase of labor postpones the request of analgesia use for pain relief for pregnant women.

  • Compare the evolution of labor and obstetric outcomes [ Time Frame: 10 hours ] [ Designated as safety issue: Yes ]
    Observe and compare the evolution of labor and obstetric outcomes in intervention and control groups

  • Satisfaction of mothers with the presence of a professional side during the study period. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Assess the degree of satisfaction of mothers of intervention and control groups, the presence of a professional side during the study period.


Enrollment: 23
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control group
Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
Other: Routine Procedures of Motherhood
Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
Experimental: Massage Group
Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Other: Lumbosacral Massage
Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.

Detailed Description:

The pain in labor appears as a subjective experience, individual interaction involving a broad physiological, psychosocial and environmental influences, representing one of the main clinical signs of this phase. Despite presenting an important biological function, is today well established the need for their relief, since its persistence is associated with harmful effects on mother and fetus. Among the available non-pharmacological resources, we highlight the massage therapy that has shown positive effects in relieving pain and promoting the comfort of the mother. 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. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p <0.05 to obtain the statistical significance of 5%.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392053

Locations
Brazil
Referral center for women's health Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:
Responsible Party: Associate professor Silvana Maria Quintana, Faculty of Medicine of Ribeirão Preto - University São Paulo
ClinicalTrials.gov Identifier: NCT01392053     History of Changes
Other Study ID Numbers: FR259127
Study First Received: July 11, 2011
Last Updated: July 11, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
labor
pain
massage

ClinicalTrials.gov processed this record on August 28, 2014