PainPhase 4NCT01600495
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
A Phase 4 study testing Experimental TENS in people with Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Experimental TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- TENS procedure intolerance
- Use of any medication or procedure that promotes pain relief
- Use of pacemaker
Trial locations and contacts
1 site in 1 country.
Brazil1 site
centro de referência para a saúde da mulher Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor
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.
Read the detailed description
Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy 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 (lumbosacral massage) 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. 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 for statistical significance of 5%.
- Conditions
- Pain
- Being tested
- Experimental TENS
- Keywords
- pain, electric stimulation, nervous, transcutaneous, humanized childbirth
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental TENSOther
Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
| Study group | Role | What they receive |
|---|---|---|
| Experimental TENS | Experimental | TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm Receives: Other: Experimental TENS |
| control Group | No intervention | Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of Pain During Labor by Visual Analogue Scale
To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.
Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)
Measured: 30 minutes
Secondary outcomes (3)
Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia
Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.
Measured: 10 hours
Duration From Start of Labor Until Birth
The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.
Measured: 10 hours
Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.
Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Cristina Marcolin, University of Sao Paulo
- Investigators
- Alessandra C Marcolin, Professor, Principal investigator, Faculty of Medicine of São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600495
- Sponsor's protocol ID
- FR259137
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2011
- Last updated
- 5 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.
PubMed 26701166
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor
- ClinicalTrials.gov ID
- NCT01600495
- Acronym / sponsor ID
- FR259137
- Conditions
- Pain
- Keywords
- pain, electric stimulation, nervous, transcutaneous, humanized childbirth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy 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 (lumbosacral massage) 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. 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 for statistical significance of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental TENS | Experimental | Other: Experimental TENSTENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm |
| control Group | No intervention | –Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- primigravida
- literate
- A single fetus in vertex position
- Low-risk Pregnancy
- From 37 weeks of gestation
Key exclusion criteria (3 listed)
- TENS procedure intolerance
- Use of any medication or procedure that promotes pain relief
- Use of pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental TENSUse of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm). | Other | Experimental TENS |
Primary outcome
Classification of Pain During Labor by Visual Analogue Scale
Time frame: 30 minutes
To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale. Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)
3 secondary outcomes
Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia
Time frame: 10 hours
Duration From Start of Labor Until Birth
Time frame: 10 hours
Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.
Time frame: 10 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26701166Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.
- VAN DER SPANK, J.T.; CAMBIER, D.C.; DE PAEPE, H.M.C.; DANNEELS, L.A.G.; WITVROUW, E.E.; BEERENS, L. Pain relief in labour by transcutaneous electrical nerve stimulation (TENS). Arch Gynecol Obstet, v.264, p.131-136 May 2000.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra C Marcolin, Professor principal investigator
Faculty of Medicine of São Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental TENS in people with Pain, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of Pain During Labor by Visual Analogue Scale (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.