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Transcutaneous Electrical Nerve Stimulation for Labor Pain Control

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DS5 electrical stimulator
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

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 - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Region Hospital Gødstrup

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

TENS1

TENS2

Sham-TENS

Arm Description

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

TENS with 80/100 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

Change in 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.
Change in Pain pressure threshold
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

First Posted
May 13, 2021
Last Updated
July 21, 2021
Sponsor
Aalborg University
Collaborators
Centaflow, Herning Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04894539
Brief Title
Transcutaneous Electrical Nerve Stimulation for Labor Pain Control
Official Title
Transcutaneous Electrical Nerve Stimulation as a Pain-relieving Approach in Labor Pain Control: a Randomized Double-blinded Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
June 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Centaflow, Herning Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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 two types of TENS frequencies (TENS1 alternating between 4 to 100 Hz and TENS2 alternating between 80 to 100 Hz) compared to sham-TENS.
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 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.

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
3 groups (TENS1, TENS2, and sham)
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS1
Arm Type
Experimental
Arm Description
TENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.
Arm Title
TENS2
Arm Type
Experimental
Arm Description
TENS with 80/100 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
Change in 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
Change in Pain pressure threshold
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
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
No
IPD Sharing Plan Description
Individual participant data is described in Danish and therefore no plan of sharing.

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Transcutaneous Electrical Nerve Stimulation for Labor Pain Control

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