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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
TENS
Region Hospital Gødstrup
Herning, Denmark
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.
Time frame: 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.
Time frame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
Satisfaction of TENS
Satisfaction rating on scale from 0 to 10 \[0 as 'no satisfaction' and 10 as 'total satisfaction'\].
Time frame: Right after last measurements of VAS & PPT
Experienced pain reduction
Response to yes or no
Time frame: Right after last measurements of VAS & PPT
Interest in the use of TENS again
Response to yes, no, or don't know
Time frame: Right after last measurements of VAS & PPT
Recommend TENS to others
Response to yes, no, or don't know
Time frame: Right after last measurements of VAS & PPT
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