NCT04946838

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor Pain

Interventions

Type	Name	Description
DEVICE	DS5 electrical stimulator	TENS

Timeline

• Start date: 2021-07-09
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2021-07-01
• Last updated: 2021-08-30

Locations

1 site across 1 country: Denmark