Transcutaneous Electrical Nerve Stimulation for Labor Pain Control
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Labor Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 3 groups (TENS1, TENS2, and sham)Masking: Double (Participant, Investigator)Masking Description: Double-blindedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 39 years
- Gender
- Only males
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 a...
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.
Tracking Information
- NCT #
- NCT04894539
- Collaborators
- Centaflow
- Herning Hospital
- Investigators
- Study Director: Parisa Gazerani, PhD Aalborg University