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IRCT20250802066727N1 IRCT 2025-11-05 Shahid Beheshti University of Medical Sciences The Effect of Acupressure on Pain Severity, Anxiety, and Vital Sign in Patients with Renal Colic Referring to the Emergency Department The Effect of Acupressure on Pain Severity, Anxiety, and Vital Sign in Patients with Renal Colic Referring to the Emergency Department 2025-10-20 anticipated 100 Recruiting https://irct.ir/trial/86789 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming the inclusion criteria, eligible participants will be randomly assigned into two groups using simple randomization. For this purpose, each participant will be assigned a number generated by a random number table or statistical software such as SPSS. The participants’ names will be recorded in the order of their entry into the study, and the corresponding numbers will be extracted from the table. Even numbers will be assigned to the intervention group (combined acupressure and pharmacological method), and odd numbers will be assigned to the control group (routine pharmacological method). To ensure allocation concealment, the group assignments of each participant will be placed in sealed, opaque envelopes prepared and numbered by an individual who is not a member of the research team. The allocation ratio in this study will be 1:1. 3 Acute renal colic pain in patients referred to the emergency department. Intervention 1: Intervention group: Participants in the intervention group will receive a combined intervention of acupressure and pharmacological treatment. Acupressure will be performed by a trained and qualified researcher on the Qiu point (corresponding to BL-23 in Traditional Chinese Medicine) along the bladder meridian in the lumbar region. The patient will lie on the side with the painful area on top. Acupressure will be applied using the thumb or index finger gradually, uniformly, and continuously, with a tolerable pressure. The procedure consists of three 1-minute pressure sessions with 30-second rests in between, totaling approximately 5 minutes. The researcher will monitor patient tolerance continuously, and the procedure will be stopped immediately if the patient feels discomfort or wishes to discontinue. Simultaneously, participants will receive the routine pharmacological pain relief according to the emergency department protocol. Intervention 2: Control group: Participants in the control group will receive routine emergency care including pharmacological pain relief according to the emergency department protocol, without any additional interventions such as acupressure or other non-pharmacological methods. Yes - There is a plan to make this available What will be shared: The data will be shared in a coded form, ensuring the confidentiality of participants’ names and personal information. When: Start of access period after results publication To whom: Researchers affiliated with academic and scientific institutions Conditions: For further investigations, addressing study limitations, and use in clinical practice Where to obtain: Dr. Fatemeh Hasan Doost fateme_hd_66@yahoo.com How to obtain: After sending an email to the author, the required data will be provided while respecting intellectual property rights. Comments:
public Fatemeh Hasan Doost
Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996835119 021 88655366-70 fateme_hd_66@yahoo.com Shahid Beheshti University of Medical Sciences scientific Fatemeh Hasan Doost
Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran
Tehran Iran (Islamic Republic of) 1996835119 021 88655366-70 fateme_hd_66@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of renal colic by the emergency department physician Age between 18 and 65 years Full consciousness (Glasgow Coma Scale score = 15) Pain intensity at the time of enrollment ranging from mild to moderate, with a score of 3 to 6 on the Visual Analogue Scale (VAS) 18 years 65 years Both Voluntary withdrawal from participation at any stage of the study History of abdominal or genitourinary surgery Need for emergency hospitalization or receiving specialized treatments outside the study protocol Lack of consistent cooperation with the study instructions and requirements N23 Unspecified renal colic Treatment - Other Treatment - Drugs Intervention group: Participants in the intervention group will receive a combined intervention of acupressure and pharmacological treatment. Acupressure will be performed by a trained and qualified researcher on the Qiu point (corresponding to BL-23 in Traditional Chinese Medicine) along the bladder meridian in the lumbar region. The patient will lie on the side with the painful area on top. Acupressure will be applied using the thumb or index finger gradually, uniformly, and continuously, with a tolerable pressure. The procedure consists of three 1-minute pressure sessions with 30-second rests in between, totaling approximately 5 minutes. The researcher will monitor patient tolerance continuously, and the procedure will be stopped immediately if the patient feels discomfort or wishes to discontinue. Simultaneously, participants will receive the routine pharmacological pain relief according to the emergency department protocol Control group: Participants in the control group will receive routine emergency care including pharmacological pain relief according to the emergency department protocol, without any additional interventions such as acupressure or other non-pharmacological methods. Pain intensity measured by the Visual Analogue Scale (VAS). Timepoint: before the intervention, 15 minutes, and 30 minutes after the intervention. Method of measurement: Visual Analogue Scale. Anxiety level measured by the Spielberger State-Trait Anxiety Inventory (STAI-S). Timepoint: before the intervention, 15 minutes, and 30 minutes after the intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory. Vital signs including pulse rate, respiratory rate, blood pressure. Timepoint: before the intervention, 15 minutes, and 30 minutes after the intervention. Method of measurement: Blood pressure will be measured using a digital sphygmomanometer, radial pulse rate will be counted manually, and respiratory rate will be recorded by observing chest movements. Shahid Beheshti University of Medical Sciences Approved 2025-10-20 Ethics Committee of the Faculties of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)