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Completed

NCT Number: NCT04894539

Transcutaneous Electrical Nerve Stimulation for Labor Pain Control

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. It is aimed to investigate two types of TENS frequencies (TENS1 alternating between 4 to 100 Hz and TENS2 alternating between 80 to 100 Hz) compared to sham-TENS.

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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Region Hospital Gødstrup

Herning, 7400, Denmark

About this study

Midwives and the study investigator will ask parturients, who are admitted to the labor ward at Region Hospital Herning satisfying the inclusion and exclusion criteria, whether they are interested in attending the experimental session.

The study will be conducted as soon as the subject is admitted at the labor ward. The study will only be conducted during early and active labor and not during the birth of the baby.

The subject in this study includes the package of a parturient and her neonate (after birth) as we also obtain data about the neonate. Hereby, two consent forms will be obtained. As this study is a non-invasive study, it is decided to have at least the consent of one parent.

The investigator will fill out a questionnaire about the parturient in cooperation with the subject and midwife, including screening questions related to inclusion and exclusion criteria before the experimental session starts.

The study will last approximately one hour and will be conducted during laboring circumstances. KT (Kenoja Thuvarakan) will carry out the experiment, and she will be present in the delivery room during the whole session.

The study includes several outcomes, including subjective and semi-objective pain measures. The primary outcome is VAS (0-10 cm scale), while secondary outcomes include PPT and satisfaction questionnaire (only at the end of the study). The subjects will be asked before, and immediately after the experimental exposure about the four outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low and high alternating frequency), which will be compared to sham-TENS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy
  • Between ages 18-39 years
  • Vertex presentation
  • Speak, read and understand Danish
  • At term (37-42 weeks gestation age)

Exclusion criteria

  • High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension, and hypotension, intrauterine growth restriction, polyhydramnios, and oligohydramnios).
  • Pre-gestational body mass index above 40 kg/m2
  • Use of fetal-scalp electrode during the experiment
  • Use of pacemakers and other electronic implants
  • Severe arrhythmia
  • Present musculoskeletal/neurological illnesses
  • Chronic pain within last 6 months
  • Present medicated mental disorders
  • Dermatological disorders
  • Use of other long-acting pain relief
  • Use of TENS 48 hours before the trial
  • Drug addiction defines as the use of cannabis, opioids, or other drugs.
  • Smokers
  • Lack of ability to cooperate

Treatment and study plan

DS5 electrical stimulator

Device

TENS

Primary outcomes

  1. Change in Visual Analog scale (VAS)

    Time frame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation

    10-cm pain intensity scale with 0 cm is no pain and 10 cm is unbearable pain. Decreased cm after baseline measurement indicates pain relief.

  2. Change in Pain pressure threshold

    Time frame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation

    Pain sensitivity measurement also defined as the minimum pressure needed to evoke a pain response measured in kPa. Increased kPa after baseline measurement indicates pain relief.

Secondary outcomes

  1. Satisfaction of TENS

    Time frame: Right after last measurements of VAS & PPT

    Satisfaction rating on scale from 0 to 10 [0 as 'no satisfaction' and 10 as 'total satisfaction'].

  2. Experienced pain reduction

    Time frame: Right after last measurements of VAS & PPT

    Response to yes or no

  3. Interest in the use of TENS again

    Time frame: Right after last measurements of VAS & PPT

    Response to yes, no, or don't know

  4. Recommend TENS to others

    Time frame: Right after last measurements of VAS & PPT

    Response to yes, no, or don't know

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Centaflow
  • Herning Hospital

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation as a Pain-relieving Approach in Labor Pain Control: a Randomized Double-blinded Controlled Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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