The Effects of Acupoint Stimulation Combined With Transcutaneous Electrical Nerve Stimulation on Labor Pain: Protocol for a Stepped Wedge Cluster Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Pain experienced during childbirth can significantly impact the progress of labor and the well-being of both the mother and the fetus. Effective management of labor pain is a crucial component of childbirth care. Nonpharmacological methods of pain relief offer notable advantages over pharmacological approaches, including enhanced maternal and fetal safety, equitable access to health care, and greater availability. Among the nonpharmacological options, transcutaneous electrical nerve stimulation (TENS) and acupoint stimulation are two commonly used methods for alleviating pain during labor. However, the clinical efficacy of these methods remains inconsistent, which hinders the generation of high-quality evidence for clinical practice. OBJECTIVE: This study aims to assess the effects of acupoint stimulation combined with TENS on labor pain, delivery outcomes, and childbirth experience for women undergoing a trial of labor. METHODS: This is a 12-month stepped wedge cluster randomized trial to be conducted in 4 labor and delivery units (LDUs) at the Obstetrics and Gynecology Hospital of Fudan University. Each unit will implement 4 types of interventions: TENS, acupoint stimulation, TENS combined with acupoint stimulation, and a control group. We aim to recruit approximately 588 pregnant women. The project will be evaluated using both quantitative and qualitative data. Quantitative data will include visual analog scale (VAS) scores, the nonpharmacological to pharmacological pain management interval (NPI), the rate of epidural analgesia, and childbirth outcomes. Qualitative data will include interviews with the women and midwives. RESULTS: The study commenced on April 1, 2023, and as of March 29, 2024, a total of 600 eligible participants have been enrolled, surpassing the initial target of 588. Data collection has been completed, including quantitative assessments of labor pain intensity, analgesic use, and childbirth outcomes, alongside qualitative interviews with participating women. Currently, data analysis is in progress, with preliminary findings anticipated to be available by March 2025. We hypothesize that TENS combined with acupoint stimulation will demonstrate greater efficacy in managing labor pain compared with standard care. This effect may be observed in key outcome measures, including the VAS score and enhanced maternal childbirth experience. CONCLUSIONS: This study protocol details the interventions of acupoint stimulation and TENS for women undergoing a trial of labor. We introduce a novel outcome indicator termed NPI, which monitors whether the application of nonpharmacological pain relief measures can delay or prevent the use of epidural analgesia. The integration of qualitative and quantitative methods will enrich the research on TENS and acupoint stimulation technology within the realm of nonpharmacological labor pain relief, providing high-quality evidence for the future establishment of industry standards and guidelines. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300069705; https://tinyurl.com/2s3mkhr7. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63050.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.041 | 0.040 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.016 | 0.007 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.005 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.048 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".