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IRCT20200206046395N7 IRCT 2025-11-22 Shahroud University of Medical Sciences The Effect of Preoperative Electroacupuncture and Acupuncture on Post-Hysterectomy Nausea and Vomiting Comparison of the Effects of Preoperative Electroacupuncture and Acupuncture on Postoperative Nausea and Vomiting in Patients Undergoing Hysterectomy: A Triple-Blind, Randomized Clinical Trial 2025-12-06 anticipated 126 Recruiting https://irct.ir/trial/87626 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization was performed using block randomization with variable block sizes to ensure balanced allocation across the three study groups. The random sequence was generated by an independent individual who was not involved in patient recruitment or intervention administration, using Random Allocation Software. Participant assignment was implemented through sequentially numbered, opaque, sealed envelopes (SNOSE). After confirming eligibility, the responsible researcher opened the next envelope in sequence to determine the participant’s group allocation. This method ensured proper randomization and allocation concealment, Blinding description: In this study, participants, the principal investigator (except for the individual who will administer the intervention), clinical staff including physicians, anesthesiologists and nurses, as well as outcome assessors and data analysts will all be kept blinded to group allocation. The intervention will be administered in a separate room by an independent individual who will be the only person aware of the assignments and will have no role in data collection, clinical care or data analysis. The appearance of the device and the needle placement procedures will be standardized across all three groups to prevent participants from identifying their assigned intervention. Clinical staff will not be informed of group assignments at any stage of patient care. Outcome data will be collected by a trained nurse who will record information solely based on participant codes and will remain unaware of group allocation. The data analyst will receive anonymized coded data and will remain blinded until all analyses are completed. Group identities will only be revealed after the final analysis by the independent individual. N/A Postoperative nausea and vomiting. Intervention 1: Intervention Group 1 (Manual Acupuncture) Participants in this group will receive manual acupuncture at the standard PC6 (Neiguan) and ST36 (Zusanli) points. The PC6 point is located approximately 2 cm (about 3 fingerbreadths) proximal to the wrist crease on the inner forearm. The ST36 point is located 3 cm (about 4 fingerbreadths) below the lower border of the patella and one fingerbreadth lateral to the anterior crest of the tibia. After skin disinfection, stainless steel needles (0.30 × 40 mm) will be inserted into these points until the patient reports a De Qi sensation (heaviness, pressure, or mild tingling). The needles will be retained for 30 minutes prior to surgery without any electrical stimulation. Intervention 2: Intervention Group 2 (Electroacupuncture) Participants in this group will receive electroacupuncture. Needle insertion at the standard PC6 and ST36 points will be performed identically to the Manual Acupuncture group. Following needle insertion and the elicitation of De Qi, electrodes from an XS-998B electroacupuncture device will be connected between the PC6 and ST36 points. Variable frequency electrical stimulation (20-100 Hz) will be applied for 30 minutes prior to surgery. The current intensity will be adjusted to a level perceived as strong but not painful by the patient. Intervention 3: Control Group (Sham Acupuncture) Participants in the control group will receive sham acupuncture. Non-penetrating, placebo needles will be placed superficially at non-specific points located approximately 2 cm away from the standard PC6 (Neiguan) and ST36 (Zusanli) acupuncture points. The needles will be inserted superficially without deep insertion or any form of stimulation (manual or electrical) and will remain in place for 30 minutes prior to surgery. This procedure is designed to mimic the psychological aspect of the intervention without producing a specific physiological effect. No - There is not a plan to make this available Justification or reason for not sharing IPD is A final decision regarding the sharing of individual participant data has not been made at this time. This matter requires further consideration of ethical issues, data confidentiality, and relevant regulations. The final decision will be made after consultation with the ethics committee and relevant stakeholders.
public Mobin Mottahedi
7th Tir Square, Shahroud University of Medical Sciences, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۵۵ +98 23 3233 8090 Mobinmottahedi1372@gmail.com Shahroud University of Medical Sciences scientific Mobin Mottahedi
7th Tir Square, Shahroud University of Medical Sciences, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۵۵ +98 23 3233 8090 mobinmottahedi1372@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 60 years American Society of Anesthesiologists (ASA) physical status class I or II Body mass index (BMI) between 20 and 30 Non-smokers Candidates for hysterectomy under general anesthesia No history of nausea or vomiting within 24 hours prior to surgery 18 years 60 years Female Pregnancy or breastfeeding Psychiatric disorders or substance abuse (self-reported) Chronic pain syndromes Self-medication with antiemetics, opioids, or corticosteroids within 3 days before surgery Presence of a cardiac pacemaker Infection at the needle insertion site Surgery duration exceeding 3 hours K91.0 Vomiting following gastrointestinal surgery Rehabilitation Rehabilitation Placebo Intervention Group 1 (Manual Acupuncture) Participants in this group will receive manual acupuncture at the standard PC6 (Neiguan) and ST36 (Zusanli) points. The PC6 point is located approximately 2 cm (about 3 fingerbreadths) proximal to the wrist crease on the inner forearm. The ST36 point is located 3 cm (about 4 fingerbreadths) below the lower border of the patella and one fingerbreadth lateral to the anterior crest of the tibia. After skin disinfection, stainless steel needles (0.30 × 40 mm) will be inserted into these points until the patient reports a De Qi sensation (heaviness, pressure, or mild tingling). The needles will be retained for 30 minutes prior to surgery without any electrical stimulation. Intervention Group 2 (Electroacupuncture) Participants in this group will receive electroacupuncture. Needle insertion at the standard PC6 and ST36 points will be performed identically to the Manual Acupuncture group. Following needle insertion and the elicitation of De Qi, electrodes from an XS-998B electroacupuncture device will be connected between the PC6 and ST36 points. Variable frequency electrical stimulation (20-100 Hz) will be applied for 30 minutes prior to surgery. The current intensity will be adjusted to a level perceived as strong but not painful by the patient. Control Group (Sham Acupuncture) Participants in the control group will receive sham acupuncture. Non-penetrating, placebo needles will be placed superficially at non-specific points located approximately 2 cm away from the standard PC6 (Neiguan) and ST36 (Zusanli) acupuncture points. The needles will be inserted superficially without deep insertion or any form of stimulation (manual or electrical) and will remain in place for 30 minutes prior to surgery. This procedure is designed to mimic the psychological aspect of the intervention without producing a specific physiological effect. The Prevalence of Postoperative Nausea and Vomiting (PONV). Timepoint: At 4, 8, 12, and 24 hours after surgery. Method of measurement: Direct questioning of patients using the following questions:'Did you feel nauseous at any time since your last visit?''Did you vomit during this period?. Nausea Severity. Timepoint: It will be evaluated and documented at 4, 8, 12, and 24 hours after surgery. Method of measurement: Assessment using a 100-millimeter Visual Analogue Scale where patients mark their symptom intensity on a straight line. Need for Postoperative Antiemetic Drugs. Timepoint: 0–4 hours, 4–8 hours, 8–12 hours, and 12–24 hours after surgery. Method of measurement: Counting the number of patients who received antiemetic drugs and their dosage. Shahroud University of Medical Sciences Approved 2025-11-15 Research Ethics Committees of Shahroud University of Medical Sciences 7th Tir Square, Shahroud University of Medical Sciences, Shahroud, Iran. Shahroud Semnan Iran (Islamic Republic of)