Massage for Pain Relief During the Active Phase of Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silvana Maria Quintana, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01392053
First received: July 11, 2011
Last updated: February 18, 2015
Last verified: February 2015
  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
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

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Effectiveness of Massage Therapy in Pain Relief During Labor. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Pharmacological Analgesia Request According to the Cervical Dilation. [ Time Frame: 10 hours ] [ Designated as safety issue: Yes ]
    In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.

  • Obstetric Outcomes - Delivery [ Time Frame: 10 hours ] [ Designated as safety issue: Yes ]
    Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.

  • Obstetric Outcomes - Duration of Labour [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into "up to 7 hours" or "more than 7 hours".

  • Obstetric Outcome - Moment of Corioamniorrhexis [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.

  • Obstetric Outcomes - Moment of Utilization of Oxytocin [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.

  • Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject.


Enrollment: 46
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
No Intervention: 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
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392053

Locations
Brazil
Referral center for women's health Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:
Responsible Party: Silvana Maria Quintana, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01392053     History of Changes
Other Study ID Numbers: FR259127
Study First Received: July 11, 2011
Results First Received: May 16, 2012
Last Updated: February 18, 2015
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 April 26, 2015