Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- University of Sao Paulo
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Effectiveness of Massage Therapy in Pain Relief During Labor.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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%.
Investigators
Silvana Maria Quintana
Associate Professor
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Nulliparous
- •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
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
Outcomes
Primary Outcomes
Effectiveness of Massage Therapy in Pain Relief During Labor.
Time Frame: 30 minutes
The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.
Secondary Outcomes
- Obstetric Outcomes - Duration of Labour(10 hours)
- Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.(30 minutes)
- Pharmacological Analgesia Request According to the Cervical Dilation.(10 hours)
- Obstetric Outcomes - Delivery(10 hours)
- Obstetric Outcome - Moment of Corioamniorrhexis(10 hours)
- Obstetric Outcomes - Moment of Utilization of Oxytocin(10 hours)