Trial Outcomes & Findings for Massage for Pain Relief During the Active Phase of Labor (NCT NCT01392053)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

30 minutes

Results posted on

2015-03-05

Participant Flow

This was a randomized and controlled non-inferiority clinical trial with a blind rater involving comparative analysis of a study group and a control group. The study included 46 parturients admitted to the Reference Center of Women's Health of Ribeirão Preto-MATER, state of São Paulo, Brazil, during the period from September 2009 to May 2010.

149 women in labour were eligible, were excluded because their women 103 not attended the criteria for inclusion (primigesta, single fetus cephalic position, low-risk pregnancy, least 37 weeks, cervical dilation 4-5 cm, spontaneous onset of labor, no use of medication during the study period, intact membranes, and no associated with risk factors).

Participant milestones

Participant milestones
Measure	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	Massage Group Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Massage for Pain Relief During the Active Phase of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	19 years STANDARD_DEVIATION 3.7 • n=5 Participants	19 years STANDARD_DEVIATION 3.2 • n=7 Participants	19 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: A pilot study was conducted previously to determine the size of the population needed. Using a paired sample t-test, with a power of 95% and 5% significance level, it was determined a minimum of 12 patients for Control Group and 16 patients for Massage Group

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.

Outcome measures

Outcome measures
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):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. Before Procedure	68.7 milimeters Standard Deviation 16.5	69.0 milimeters Standard Deviation 14.5
Effectiveness of Massage Therapy in Pain Relief During Labor. After Procedure	72.1 milimeters Standard Deviation 15.4	51.7 milimeters Standard Deviation 19.9

SECONDARY outcome

Timeframe: 10 hours

Population: Of the 46 patients who where evaluated, only 1 (one) in each group didn't request pharmacological analgesia and, thus, were excluded of the analysis of this specific outcome

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.

Outcome measures

Outcome measures
Measure	Control Group n=22 Participants 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	Massage Group n=22 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Pharmacological Analgesia Request According to the Cervical Dilation.	6 centimeters Standard Deviation 1.2	7 centimeters Standard Deviation 1.3

SECONDARY outcome

Timeframe: 10 hours

Population: All patients of both groups were analyzed.

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.

Outcome measures

Outcome measures
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Obstetric Outcomes - Delivery Vaginal	19 participants	17 participants
Obstetric Outcomes - Delivery Caesarian section	4 participants	6 participants

SECONDARY outcome

Timeframe: 10 hours

Population: All patients in both groups were analyzed

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".

Outcome measures

Outcome measures
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Obstetric Outcomes - Duration of Labour Up to 7 hours	83 percentage of participants	57 percentage of participants
Obstetric Outcomes - Duration of Labour More than 7 hours	17 percentage of participants	43 percentage of participants

SECONDARY outcome

Timeframe: 10 hours

Population: All patients in both groups were analyzed

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.

Outcome measures

Outcome measures
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Obstetric Outcome - Moment of Corioamniorrhexis	8.0 centimeters Standard Deviation 1.7	7.5 centimeters Standard Deviation 1.7

SECONDARY outcome

Timeframe: 10 hours

Population: All patients in both groups were analyzed

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.

Outcome measures

Outcome measures
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Obstetric Outcomes - Moment of Utilization of Oxytocin	6.0 centimeters Standard Deviation 2.0	5.0 centimeters Standard Deviation 2.8

SECONDARY outcome

Timeframe: 30 minutes

Population: All patients participatin in the study answered a satisfaction questionnaire after labour.

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.

Outcome measures

Outcome measures
Measure	Control Group n=23 Participants 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	Massage Group n=23 Participants Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. Considered important presence of physiotherapist	23 participants	23 participants
Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. Rated excellent the therapy received	16 participants	15 participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Massage Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Silvana Quintana

Universidade de São Paulo

Phone: 55 16 3602-2813

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place