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Completed

NCT Number: NCT04946838

Transcutaneous Electrical Nerve Stimulation for Labor Pain Control in Combination With Cardiotocography

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 TENS1 alternating between 4 to 100 Hz compared to sham-TENS.

The present study aims to evaluate TENS in combination with cardiotocography (CTG).

The combination of TENS with CTG in a feedback-loop has not been reported in any studies before.

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Key information

Age range

18 year and older

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 screening questionnaire about the laboring parturient in cooperation with the subject and the 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 outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low-to-high and high alternating frequency), which will be compared to sham-TENS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Singleton pregnancy
  • Vertex presentation
  • Speak, read and understand Danish

Exclusion criteria

  • Gestational age < 37+0 weeks
  • Gestational age > to 41+6 weeks
  • High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension (above 140/90), and hypotension (below 90/60), Intrauterine growth restriction (IUGR), polyhydramnious, and oligohydramnious).
  • Pre-gestational body mass index (BMI) above 40 kg/m2
  • Use of fetal scalp-electrode during the experiment
  • Use of pacemakers and other electronic implants
  • Severe arrhythmia
  • Present musculoskeletal illnesses (including myopathy and arthritis).
  • Chronic pain within last 6 months (Pelvic girdle pain (PGP) to a mild degree (VAS 0-6 cm) is accepted in the experiment. Severe degree (VAS 6-10 cm) (e.g. bedridden or difficulty walking) especially within 24 hours before birth is excluded).
  • Present/previous neurologic illnesses (including epilepsy, migraine, and sclerosis).
  • Present medicated mental disorders (including dementia, personality disorders, bipolar, ADHD, and anxiety).
  • Dermatological disorders (including skin allergy, tattoos or scars on the locations of electrodes)
  • Use of other long-acting pain relief before the experiment (including Epidural, Morphine less than 16 hours before experiment), Acupuncture, Paracetamol (less than 8 hours before experiment), Cocktail (less than 8 hours before experiment), nitrous oxide (less than one hour before experiment), sterile water injection (less than two hours before experiment).
  • Use of TENS 48 hours before the trial
  • Drug addiction defined 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. 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. Pain pressure threshold (PPT)

    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

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2021
Registry last updated
Aug 30, 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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