Massage for Pain Relief During the Active Phase of Labor

NCT ID: NCT01392053

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-07-31

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%.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Massage Group

Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation

Group Type: EXPERIMENTAL

Lumbosacral Massage

Intervention Type: OTHER

Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.

Interventions

Lumbosacral Massage

Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Silvana Maria Quintana

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Referral center for women's health Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 11895532 (View on PubMed)

Other Identifiers

FR259127

Identifier Type: -

Identifier Source: org_study_id