Clinical trial NCT04894539: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: TENS
Labor pain
Childbirth
RCT
Pilot study
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Centaflow
name: Herning Hospital
First posted: 2021-05-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups (TENS1, TENS2, and sham)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Visual Analog scale (VAS)
timeFrame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
measure: Change in Pain pressure threshold
timeFrame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
Secondary outcomes:
measure: Satisfaction of TENS
timeFrame: Right after last measurements of VAS & PPT
measure: Experienced pain reduction
timeFrame: Right after last measurements of VAS & PPT
measure: Interest in the use of TENS again
timeFrame: Right after last measurements of VAS & PPT
measure: Recommend TENS to others
timeFrame: Right after last measurements of VAS & PPT
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Region Hospital Gødstrup
Study officials:
affiliation: Aalborg University
name: Parisa Gazerani, PhD
role: STUDY_DIRECTOR
References: