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

NCT03137251 | Completed

• 1 other identifier: ABSuarez
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Midwifery; Pregnancy

Keywords

Transcutaneous electrical nerve stimulation; TENS; Analgesia; Labour pain; Physical therapy modality

Outcome Measures

Primary Outcomes (2)

• Pain (VAS)

  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".

  - At the beginning of the use of TENS, 10 minutes later and 30 minutes later; for measuring the change of pain.

• Pregnant Satisfaction

  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.

  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.

Study Arms (3)

TENS 1

EXPERIMENTAL

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; Device: TENS 2

TENS 2

EXPERIMENTAL

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; Device: Placebo TENS

Placebo TENS

SHAM COMPARATOR

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; Device: Placebo TENS

Interventions

TENS 1 DEVICE

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.

Placebo TENS; TENS 1

TENS 2 DEVICE

An intervention similar to arm 1 will be performed but with different doses.

TENS 1; TENS 2

Placebo TENS DEVICE

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

Placebo TENS; TENS 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: The participants will be pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

University of Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Related Publications (18)

• Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.

  PMID: 12011870 BACKGROUND

• Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.

  PMID: 21072284 BACKGROUND

• Simkin P, Bolding A. Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. J Midwifery Womens Health. 2004 Nov-Dec;49(6):489-504. doi: 10.1016/j.jmwh.2004.07.007.

  PMID: 15544978 BACKGROUND

• Reynolds F. Labour analgesia and the baby: good news is no news. Int J Obstet Anesth. 2011 Jan;20(1):38-50. doi: 10.1016/j.ijoa.2010.08.004. Epub 2010 Dec 13.

  PMID: 21146977 BACKGROUND

• Lieberman E, O'donoghue C. Unintended effects of epidural analgesia during labor: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S31-68. doi: 10.1067/mob.2002.122522.

  PMID: 12011872 BACKGROUND

• Liu EH, Sia AT. Rates of caesarean section and instrumental vaginal delivery in nulliparous women after low concentration epidural infusions or opioid analgesia: systematic review. BMJ. 2004 Jun 12;328(7453):1410. doi: 10.1136/bmj.38097.590810.7C. Epub 2004 May 28.

  PMID: 15169744 BACKGROUND

• Anim-Somuah M, Smyth R, Howell C. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000331. doi: 10.1002/14651858.CD000331.pub2.

  PMID: 16235275 BACKGROUND

• Cambic CR, Wong CA. Labour analgesia and obstetric outcomes. Br J Anaesth. 2010 Dec;105 Suppl 1:i50-60. doi: 10.1093/bja/aeq311.

  PMID: 21148655 BACKGROUND

• Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

  PMID: 22419342 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Tournaire M, Theau-Yonneau A. Complementary and alternative approaches to pain relief during labor. Evid Based Complement Alternat Med. 2007 Dec;4(4):409-17. doi: 10.1093/ecam/nem012.

  PMID: 18227907 BACKGROUND

• Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.

  PMID: 18780582 BACKGROUND

• Wang SM, Kain ZN, White P. Acupuncture analgesia: I. The scientific basis. Anesth Analg. 2008 Feb;106(2):602-10. doi: 10.1213/01.ane.0000277493.42335.7b.

  PMID: 18227322 BACKGROUND

• Chao AS, Chao A, Wang TH, Chang YC, Peng HH, Chang SD, Chao A, Chang CJ, Lai CH, Wong AMK. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor: a randomized double-blind placebo-controlled trial. Pain. 2007 Feb;127(3):214-220. doi: 10.1016/j.pain.2006.08.016. Epub 2006 Oct 6.

  PMID: 17030438 BACKGROUND

• Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.

  PMID: 19370680 BACKGROUND

• 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.

  PMID: 26701166 BACKGROUND

• Gungor I, Beji NK. Development and psychometric testing of the scales for measuring maternal satisfaction in normal and caesarean birth. Midwifery. 2012 Jun;28(3):348-57. doi: 10.1016/j.midw.2011.03.009. Epub 2011 May 4.

  PMID: 21546142 BACKGROUND

• Baez-Suarez A, Martin-Castillo E, Garcia-Andujar J, Garcia-Hernandez JA, Quintana-Montesdeoca MP, Loro-Ferrer JF. Evaluation of different doses of transcutaneous nerve stimulation for pain relief during labour: a randomized controlled trial. Trials. 2018 Nov 26;19(1):652. doi: 10.1186/s13063-018-3036-2.

  PMID: 30477529 DERIVED

MeSH Terms

Conditions

Agnosia; Labor Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Juan Francisco Loro, Professor

  University of Las Palmas de Gran Canaria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: May 2, 2017
• Study Start: May 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)