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IRCT20251026067766N1 IRCT 2025-11-04 Khoram-Abad University of Medical Sciences A Comparative Study on the Effects of Acupressure at Neiguan (PC6) and Sanyinjiao (SP6) Points on Post-Cesarean Pain A Comparative Study on the Effects of Acupressure at Neiguan (PC6) and Sanyinjiao (SP6) Points on Post-Cesarean Pain in Primiparous Women 2025-11-08 anticipated 108 Complete https://irct.ir/trial/87030 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A total of 108 women who give birth by cesarean section in Rafsanjan maternity hospitals will be selected purposively based on the inclusion and exclusion criteria. They will then be randomly assigned to three groups (two intervention groups and one control group) so that both groups are identical in terms of pain intensity after cesarean section. The first person will be assigned to the groups by simple randomization and the rest will be based on the total number of samples in each location. Sampling will continue until the desired sample size is reached. Given that numerous factors can affect pain, but ultimately these factors are measured in the pre-test pain intensity, the three groups will be matched based on the pre-test pain intensity, Blinding description: This study is designed as a single-blind clinical trial; participants will not be aware of the type of intervention they will receive (real or apparent pressure). In order to increase the validity of the results and reduce bias, in the control group, the intervention will be performed in the form of superficial touch on the acupressure point (PC6 or SP6) without applying pressure; while in the intervention group, the same points will be stimulated with standard pressure in accordance with the scientific principles of acupressure. Both types of interventions will be performed in completely identical environmental conditions and by a trained person (the principal investigator). During the study, participants will only be presented with a general explanation of "applying contact to one of the body points to investigate its effect on post-cesarean section pain" and will not be aware of the type of contact (real or apparent). To prevent the transfer of information between participants, interventions will be performed in separate rooms, with silence, minimal traffic, and no companion present. Participants are also asked not to discuss with others how they feel or what type of contact they receive during the study. N/A Women who will undergo a cesarean section. Intervention 1: Intervention group: After regaining consciousness, these individuals are placed in a supine position with the researcher facing them. The intervention is performed in two sessions (the second and fourth hours after cesarean section). In each session, after gentle massage of the area for 20 to 30 seconds, intermittent finger pressure is applied for 2 minutes in cycles of 5 seconds of pressure and 2 seconds of rest. The Neiguan point (PC6) is located on the inner surface of the forearm, about three fingers above the wrist crease and between the flexor carpi radialis and phallus longus tendons. The pressure is such that the researcher's fingernails change color and the mother feels warmth and mild pain. Intervention 2: Intervention group: After regaining consciousness, the subjects were placed in a supine position, and the researcher stood at the bedside. The intervention was performed in two sessions (the second and fourth hours after cesarean section). In each session, after gentle massage of the area for 20 to 30 seconds, intermittent finger pressure was applied for 2 minutes in cycles of 5 seconds of pressure and 2 seconds of rest. The Sanyinjiao point (SP6) is located on the inner surface of the lower leg, about three fingers above the medial ankle and behind the inner edge of the tibia. The pressure was applied in such a way that the researcher's fingernails were discolored and the mother felt warmth and mild pain. Intervention 3: Control group: After regaining consciousness and returning sensation in the lower limbs, the subjects will lie on their backs, with the researcher facing them. In this group, the intervention will be performed in the form of superficial touch without applying actual pressure. To maintain blinding conditions, some participants will be contacted at the Neiguan point (PC6) and others at the Sanyinjiao point (SP6). This superficial contact will last for 20 seconds, and no deep pressure will be applied so that the participants will not be able to recognize the actual type of intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Farahnaz Changaee
Nasser Khosrow Street - Phase 1 Farhangian
Khorramabad Iran (Islamic Republic of) 6816957385 +98 916 367 1239 farahnazchangavi@yahoo.com Khoram-Abad University of Medical Sciences scientific Farahnaz Changaee
Nasser Khosrow Street - Phase 1 Farhangian
Khorramabad Iran (Islamic Republic of) 6816957385 +98 916 367 1239 farahnazchangavi@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Primiparous women with their first cesarean delivery by a designated gynecologist at Shahid Rahimi Hospital, Khorramabad Age between 18 and 45 years Singleton pregnancy Spinal anesthesia (not general anesthesia) to reduce the effects of side variables on pain intensity Including planned (elective) and emergency cesarean sections 18 years 45 years Female Women who have experienced severe surgical complications during and after cesarean section (such as severe bleeding, hemorrhagic shock, damage to internal organs or severe reactions to anesthetic drugs, etc.). Mothers whose infants have been admitted to the neonatal intensive care unit (NICU). Women who leave the hospital before completing the study period. Women with underlying diseases that affect pain such as fibromyalgia, diabetic neuropathy or chronic musculoskeletal problems. Use of patient-controlled anesthesia (PCA) after cesarean section. Presence of cognitive or communication disorders that prevent proper assessment of pain. Use of strong analgesics (morphine, ketamine, methicarbamol, tramadol, opioids) that can affect the effect of the intervention. History of using acupressure or acupuncture. The presence of any skin lesions, burns, superficial or deep wounds, irritation, skin diseases (such as eczema, psoriasis) or rheumatic diseases in the area of ​​the intervention (points SP6 and PC6). O82 Single delivery by caesarean section Treatment - Other Treatment - Other Other Intervention group: After regaining consciousness, these individuals are placed in a supine position with the researcher facing them. The intervention is performed in two sessions (the second and fourth hours after cesarean section). In each session, after gentle massage of the area for 20 to 30 seconds, intermittent finger pressure is applied for 2 minutes in cycles of 5 seconds of pressure and 2 seconds of rest. The Neiguan point (PC6) is located on the inner surface of the forearm, about three fingers above the wrist crease and between the flexor carpi radialis and phallus longus tendons. The pressure is such that the researcher's fingernails change color and the mother feels warmth and mild pain. Intervention group: After regaining consciousness, the subjects were placed in a supine position, and the researcher stood at the bedside. The intervention was performed in two sessions (the second and fourth hours after cesarean section). In each session, after gentle massage of the area for 20 to 30 seconds, intermittent finger pressure was applied for 2 minutes in cycles of 5 seconds of pressure and 2 seconds of rest. The Sanyinjiao point (SP6) is located on the inner surface of the lower leg, about three fingers above the medial ankle and behind the inner edge of the tibia. The pressure was applied in such a way that the researcher's fingernails were discolored and the mother felt warmth and mild pain. Control group: After regaining consciousness and returning sensation in the lower limbs, the subjects will lie on their backs, with the researcher facing them. In this group, the intervention will be performed in the form of superficial touch without applying actual pressure. To maintain blinding conditions, some participants will be contacted at the Neiguan point (PC6) and others at the Sanyinjiao point (SP6). This superficial contact will last for 20 seconds, and no deep pressure will be applied so that the participants will not be able to recognize the actual type of intervention. Pain after cesarean section. Timepoint: After entering the ward immediately after cesarean section, before and after intervention in the second hour after cesarean section, before and after intervention in the fourth hour after cesarean section. Method of measurement: With the VAS scale. Amount of painkiller used. Timepoint: After entering the ward immediately after cesarean section, after intervention in the second hour after cesarean section, after intervention in the fourth hour after cesarean section. Method of measurement: medication record form. - Approved 2025-09-23 Ethics Committee of Lorestan University of Medical Sciences 4th kilometer of Khorramabad-Borojerd road, Medical Sciences Campus Khorramabad Lorestan Iran (Islamic Republic of)