Phase 4
N=46
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01600495 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Classification of Pain During Labor by Visual Analogue Scale — 57.0; 72.1 mm — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Experimental TENS (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of Sao Paulo
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Classification of Pain During Labor by Visual Analogue Scale |
57.0; 72.1 | 0.01 sig |
| SECONDARY Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia |
7.0; 6.41 | 0.25 |
| SECONDARY Duration From Start of Labor Until Birth |
393; 322 | — |
| SECONDARY Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor. |
17; 7 | <0.01 sig |
Summary
The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated 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, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.
Eligibility Criteria
Inclusion Criteria
- primigravida
- literate
- A single fetus in vertex position
- Low-risk Pregnancy
- From 37 weeks of gestation
- Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage
- Labor in early spontaneous
- No use of medications during the study period
- Absence of cognitive or psychiatric problems
- Intact membranes
- No risk factors associated
- Who wish to participate and signed the informed consent
Exclusion Criteria
- TENS procedure intolerance
- Use of any medication or procedure that promotes pain relief
- Use of pacemaker
Data sourced from ClinicalTrials.gov (NCT01600495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.