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Evaluation of the Effectiveness of Transcutaneous Electrical Nerve Stimulation During Labor.

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ClinicalTrials.gov Identifier: NCT03137251
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Aníbal Báez Suárez, University of Las Palmas de Gran Canaria

Brief Summary:

This study evaluates the effectiveness of the Transcutaneus Electric Nerve Stimulation (TENS) during the labour. TENS is a low frequency electrotherapy technique, analgesic type, generally used in musculoskeletal pathology.

The investigators will have three groups of participants to be administered the TENS, a different dose in two groups, while the third will correspond to placebo.

The hypothesis of the study is to verify if the TENS is effective as a non-pharmacological method in the relief of pain during childbirth


Condition or disease Intervention/treatment Phase
Midwifery Pregnancy Device: TENS 1 Device: TENS 2 Device: Placebo TENS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of Transcutaneous Electrical Nerve Stimulation During Labor. A Triple Blind Randomized Clinical Trial
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : September 30, 2018

Arm Intervention/treatment
Experimental: TENS 1

This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour.

Dose TENS 1: Biphasic asymmetric pulse, pulse width of 100 µs and a frequency of 100 Hz. The intensity is individually titrated according to the sensitivity of the parturient.

Device: TENS 1
A portable TENS unit will be used by the principal investigator to apply the experimental intervention. Two pairs of electrodes measuring 5 x 9 cm will be fixed on the paravertebral regions of the participants of the experimental group using hypoallergenic surgical tape. Two paired electrodes will be placed 1 cm laterally on either side of the spine at the T10 to L1 and S2 to S4 levels.

Device: TENS 2
An intervention similar to arm 1 will be performed but with different doses.

Experimental: TENS 2

This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour.

Dose TENS 2: Biphasic asymmetric pulse, pulse width of 350 µs and a variable frequency between 80 and 100Hz. The intensity is individually titrated according to the sensitivity of the parturient.

Device: TENS 2
An intervention similar to arm 1 will be performed but with different doses.

Device: Placebo TENS
An intervention similar to arm 1and 2 will be performed but,in this case, it is a sham device.

Sham Comparator: Placebo TENS
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour. However, TENS has been modified, so that it emits light and sound but does not transmit electrical current.
Device: TENS 1
A portable TENS unit will be used by the principal investigator to apply the experimental intervention. Two pairs of electrodes measuring 5 x 9 cm will be fixed on the paravertebral regions of the participants of the experimental group using hypoallergenic surgical tape. Two paired electrodes will be placed 1 cm laterally on either side of the spine at the T10 to L1 and S2 to S4 levels.

Device: Placebo TENS
An intervention similar to arm 1and 2 will be performed but,in this case, it is a sham device.




Primary Outcome Measures :
  1. Pain (VAS) [ Time Frame: - At the beginning of the use of TENS, 10 minutes later and 30 minutes later; for measuring the change of pain. ]

    The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS).

    Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".


  2. Pregnant Satisfaction [ Time Frame: Twenty-four hours postpartum, other midwife will ask participants to answer questions regarding their satisfaction with the care provided (COMFORTS scale) and if they would prefer to receive the same type of care in the future. ]

    The investigators will use a scale called Care in Obstetrics : measure for testing satisfaction (COMFORTS). This scale measures satisfaction during delivery and the postnatal period.

    . This scale is a valid and reliable scale to measure women's satisfaction with the care during labour and postpartum period. The investigators obtained the authorization to use the Spanish version of the COMFORTS scale.




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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The participants will be pregnant women.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parturients with a low-risk pregnancy.
  • A gestational age > 37 weeks.
  • A single foetus.
  • Cervical dilation of 4 cm.
  • To be older than 18 years old.
  • Visual deficit that causes difficulty to take the Visual Scale Analogue.

Exclusion Criteria:

  • Refusal to take part in the survey.
  • Failure to Sign Consent Form.
  • Planned Cesarean.
  • High-risk pregnancy.
  • Present skin lesions in the area of the application of the electrodes.
  • Pregnant with physical or mental handicap that prevents the application of the TENS device.
  • Have implanted pacemakers or automatic defibrillators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137251


Locations
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Spain
University of Las Palmas de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Sponsors and Collaborators
University of Las Palmas de Gran Canaria
Investigators
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Study Director: Juan Francisco Loro, Professor University of Las Palmas de Gran Canaria

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aníbal Báez Suárez, Physiotherapist, University of Las Palmas de Gran Canaria
ClinicalTrials.gov Identifier: NCT03137251     History of Changes
Other Study ID Numbers: ABSuarez
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aníbal Báez Suárez, University of Las Palmas de Gran Canaria:
Transcutaneous electrical nerve stimulation
TENS
Analgesia
Labour pain
Physical therapy modality