Labor Pain
Conditions
Keywords
TENS, Labor pain, Childbirth, RCT, Pilot study
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.
Interventions
TENS
Sponsors
Centaflow
Herning Hospital
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
3 groups (TENS1, TENS2, and sham)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog scale (VAS) | 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. |
| Change in Pain pressure threshold | 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of TENS | Right after last measurements of VAS & PPT | Satisfaction rating on scale from 0 to 10 \[0 as 'no satisfaction' and 10 as 'total satisfaction'\]. |
| Experienced pain reduction | Right after last measurements of VAS & PPT | Response to yes or no |
| Interest in the use of TENS again | Right after last measurements of VAS & PPT | Response to yes, no, or don't know |
| Recommend TENS to others | Right after last measurements of VAS & PPT | Response to yes, no, or don't know |
Countries
Denmark
Outcome results
None listed