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
Results First Received: May 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Pain
Intervention: Other: Lumbosacral Massage

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Control Group     Massage Group  
STARTED     23     23  
COMPLETED     23     23  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Control Group     Massage Group     Total  
Number of Participants  
[units: participants]
  23     23     46  
Age  
[units: participants]
     
<=18 years     9     10     19  
Between 18 and 65 years     14     13     27  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  19  ± 3.7     19  ± 3.2     19  ± 3.5  
Gender  
[units: participants]
     
Female     23     23     46  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Brazil     23     23     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effectiveness of Massage Therapy in Pain Relief During Labor.   [ Time Frame: 30 minutes ]

2.  Secondary:   Pharmacological Analgesia Request According to the Cervical Dilation.   [ Time Frame: 10 hours ]

3.  Secondary:   Obstetric Outcomes - Delivery   [ Time Frame: 10 hours ]

4.  Secondary:   Obstetric Outcomes - Duration of Labour   [ Time Frame: 10 hours ]

5.  Secondary:   Obstetric Outcome - Moment of Corioamniorrhexis   [ Time Frame: 10 hours ]

6.  Secondary:   Obstetric Outcomes - Moment of Utilization of Oxytocin   [ Time Frame: 10 hours ]

7.  Secondary:   Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.   [ Time Frame: 30 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The influence of the pain of other women in labor or under the effect of childbirth analgesia; Accompanying with no physical or emotional preparation; Brazilian culture, which associates pain with suffering.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof Silvana Quintana
Organization: Universidade de São Paulo
phone: 55 16 3602-2813
e-mail: quintana@fmrp.usp.br


Publications of Results:

Responsible Party: Silvana Maria Quintana, 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