Massage for Pain Relief During the Active Phase of Labor
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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 |
- 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.
- 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 |
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
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 May 22, 2013