NCT04894539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

May 13, 2021

Last Update Submit

July 21, 2021

Conditions

Labor Pain

Keywords

TENSLabor painChildbirthRCTPilot study

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 10 minutes post stimulation, 30 minutes post stimulation

  • 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.

    Baseline, 10 minutes post stimulation, 30 minutes post stimulation

Secondary Outcomes (4)

  • Satisfaction of TENS

    Right after last measurements of VAS & PPT

  • Experienced pain reduction

    Right after last measurements of VAS & PPT

  • Interest in the use of TENS again

    Right after last measurements of VAS & PPT

  • Recommend TENS to others

    Right after last measurements of VAS & PPT

Study Arms (3)

TENS1

EXPERIMENTAL

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

Device: DS5 electrical stimulator

TENS2

EXPERIMENTAL

TENS with 80/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.

Device: DS5 electrical stimulator

Sham-TENS

SHAM COMPARATOR

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

Device: DS5 electrical stimulator

Interventions

DS5 electrical stimulatorDEVICE

TENS

Sham-TENSTENS1TENS2

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Hospital Gødstrup

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Parisa Gazerani, PhD

    Aalborg University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups (TENS1, TENS2, and sham)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 20, 2021

Study Start

August 1, 2019

Primary Completion

April 5, 2021

Study Completion

June 6, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Individual participant data is described in Danish and therefore no plan of sharing.

Locations

DK(1)