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

Primary Purpose

Labor Pain

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

DS5 electrical stimulator

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring TENS, Labor pain, Childbirth, RCT, Pilot study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Region Hospital Gødstrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TENS

Sham-TENS

Arm Description

TENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.

Sham with 100 Hz in frequency, 200 µs in pulse duration, and intensity below 5 mA.

Outcomes

Primary Outcome Measures

Visual Analog scale (VAS)

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.

Pain pressure threshold (PPT)

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 Outcome Measures

Satisfaction of TENS

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

Experienced pain reduction

Response to yes or no

Interest in the use of TENS again

Response to yes, no, or don't know

Recommend TENS to others

Response to yes, no, or don't know

Full Information

NCT ID

NCT04946838

First Posted

June 23, 2021

Last Updated

August 27, 2021

Sponsor

Aalborg University

Collaborators

Centaflow

1. Study Identification

Unique Protocol Identification Number

NCT04946838

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

July 9, 2021 (Actual)

Primary Completion Date

August 13, 2021 (Actual)

Study Completion Date

August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University

Collaborators

Centaflow

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Pain

Keywords

TENS, Labor pain, Childbirth, RCT, Pilot study

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

2 groups (TENS and sham)

Masking

ParticipantInvestigator

Masking Description

Double-blinded

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TENS

Arm Type

Experimental

Arm Description

TENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.

Arm Title

Sham-TENS

Arm Type

Sham Comparator

Arm Description

Sham with 100 Hz in frequency, 200 µs in pulse duration, and intensity below 5 mA.

Intervention Type

Device

Intervention Name(s)

DS5 electrical stimulator

Intervention Description

TENS

Primary Outcome Measure Information:

Title

Visual Analog scale (VAS)

Description

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.

Time Frame

Baseline, 10 minutes post stimulation, 30 minutes post stimulation

Title

Pain pressure threshold (PPT)

Description

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.

Time Frame

Baseline, 10 minutes post stimulation, 30 minutes post stimulation

Secondary Outcome Measure Information:

Title

Satisfaction of TENS

Description

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

Time Frame

Right after last measurements of VAS & PPT

Title

Experienced pain reduction

Description

Response to yes or no

Time Frame

Right after last measurements of VAS & PPT

Title

Interest in the use of TENS again

Description

Response to yes, no, or don't know

Time Frame

Right after last measurements of VAS & PPT

Title

Recommend TENS to others

Description

Response to yes, no, or don't know

Time Frame

Right after last measurements of VAS & PPT

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parisa Gazerani, PhD

Organizational Affiliation

Aalborg University

Official's Role

Study Director

Facility Information:

Facility Name

Region Hospital Gødstrup

City

Herning

ZIP/Postal Code

7400

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study protocol and individual participant data will be available.

IPD Sharing Time Frame

The study protocol will also be published after the manuscript publication. Expected to be published after September 2021.

Learn more about this trial

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

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