Clinical trial NCT01392053: Massage for Pain Relief During the Active Phase of Labor
Official title: Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: labor
pain
massage
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 46
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Effectiveness of Massage Therapy in Pain Relief During Labor.
timeFrame: 30 minutes
Secondary outcomes:
measure: Pharmacological Analgesia Request According to the Cervical Dilation.
timeFrame: 10 hours
measure: Obstetric Outcomes - Delivery
timeFrame: 10 hours
measure: Obstetric Outcomes - Duration of Labour
timeFrame: 10 hours
measure: Obstetric Outcome - Moment of Corioamniorrhexis
timeFrame: 10 hours
measure: Obstetric Outcomes - Moment of Utilization of Oxytocin
timeFrame: 10 hours
measure: Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Referral center for women's health Ribeirão Preto
state: São Paulo
Study officials:
References:
citation: 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.