Region Hospital Gødstrup
Herning, 7400, Denmark
NCT Number: NCT04946838
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Herning, 7400, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TENS
Time frame: 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.
Time frame: 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.
Time frame: Right after last measurements of VAS & PPT
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
Response to yes or no
Time frame: Right after last measurements of VAS & PPT
Response to yes, no, or don't know
Time frame: Right after last measurements of VAS & PPT
Response to yes, no, or don't know
Aalborg University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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