Massage for Pain Relief During the Active Phase of Labor

Pain Clinical Trial

Official title:

Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392053
• Other study ID #: FR259127
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2011
• Last updated: February 18, 2015
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Referral center for women's health Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Massage Therapy in Pain Relief During Labor.	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.	30 minutes	Yes
Secondary	Pharmacological Analgesia Request According to the Cervical Dilation.	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.	10 hours	Yes
Secondary	Obstetric Outcomes - Delivery	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.	10 hours	Yes
Secondary	Obstetric Outcomes - Duration of Labour	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".	10 hours	No
Secondary	Obstetric Outcome - Moment of Corioamniorrhexis	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.	10 hours	No
Secondary	Obstetric Outcomes - Moment of Utilization of Oxytocin	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.	10 hours	No
Secondary	Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.	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.	30 minutes	Yes