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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

July 11, 2011
July 11, 2011
September 2009
September 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

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%.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Pain
  • Other: Lumbosacral Massage
    Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
  • 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
  • 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
    Intervention: Other: Routine Procedures of Motherhood
  • Experimental: Massage Group
    Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
    Intervention: Other: Lumbosacral Massage
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
July 2011
September 2010   (final data collection date for primary outcome measure)

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
Female
15 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01392053
FR259127
Yes
Associate professor Silvana Maria Quintana, Faculty of Medicine of Ribeirão Preto - University São Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP