Massage for Pain Relief During the Active Phase of Labor
|ClinicalTrials.gov Identifier: NCT01392053|
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : March 5, 2015
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Lumbosacral Massage||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor|
|Study Start Date :||September 2009|
|Primary Completion Date :||September 2010|
|Study Completion Date :||July 2011|
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.
- 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.
- Pharmacological Analgesia Request According to the Cervical Dilation. [ Time Frame: 10 hours ]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 ]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 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392053
|Referral center for women's health Ribeirão Preto|
|Ribeirão Preto, São Paulo, Brazil, 14048-900|