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

Tracking Information
First Received Date ^ICMJE	July 11, 2011
Last Updated Date	July 11, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 11, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 11, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Massage for Pain Relief During the Active Phase of Labor
Official Title ^ICMJE	Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor
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.
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%.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Pain
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	23
Completion Date	July 2011
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	15 Years to 30 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01392053
Other Study ID Numbers ^ICMJE	FR259127
Has Data Monitoring Committee	Yes
Responsible Party	Associate professor Silvana Maria Quintana, Faculty of Medicine of Ribeirão Preto - University São Paulo
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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