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IRCT20200206046395N1 IRCT 2022-02-05 Kermanshah University of Medical Sciences Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy 2022-02-20 anticipated 180 Complete https://irct.ir/trial/61595 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Pre-sampling of the type will be available. Then, the samples studied in this study will be placed in the study groups (control, TENS intervention and massage intervention) using random allocation of patients. The random allocation sequence is determined using the block method with a volume of 6 using the software, Blinding description: The present study is double-blind because participants receiving the intervention are aware of the intervention. The data collector will not be aware of the patient group. The data analyzer will not be aware of the patient group. N/A Laparoscopic cholecystectomy. Intervention 1: Intervention group: Massage - Massage therapy group 30 minutes with three massage methods Petrisag-Kneading-Friction in the hand area. This technique is performed three times after cholecystectomy (4, 8 and 12 hours after surgery). Patients' pain intensity is measured and recorded 20 minutes before and after each massage with the Visual Pain Scale (VAS). Intervention 2: Intervention group: TENS In the TENS method, electrodes are placed near or on the shoulder pain site and send the stimuli created by the device to the skin to stimulate the sensory-nerve terminals. Also, in order to achieve effective and rapid pain relief, the TENS current (frequency of 150 Hz and a pulse width of 75 μs) Used for 30 minutes. the intensity of each channel was increased until the participant was able to feel a maximal tolerable tingling sensation without causing discomfort, pain, or muscle contraction.This technique is performed three times after cholecystectomy (4, 8 and 12 hours after surgery). Patients' pain intensity is measured and recorded 20 minutes before and after each TENS with a Visual Analogue Scale (VAS). Intervention 3: Control group: Get routine care. Yes - There is a plan to make this available What will be shared: Individual participant data collected for the primary outcome measures When: After publication for one year To whom: For all people who request for data Conditions: It is allowed to perform any analysis on the data, but use of data for publication is not allowed. Where to obtain: Corresponding author of article How to obtain: After requesting the data by email to corresponding author , the data will be sent after a maximum period of one week Comments:
public MOBIN MOTTAHEDI
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shahrood Iran (Islamic Republic of) 3618675313 009832338090 Mobinmottahedi1372@gmail.com Kermanshah University of Medical Sciences scientific MOBIN MOTTAHEDI
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shahrood Iran (Islamic Republic of) 3618675313 009832338090 mobinmottahedi1372@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) A VAS Shoulder pain intensity score at baseline (within 3 hours after surgery) of greater than or equal to 30 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable. According to the American Society of Anesthesiology (ASA) classification, the patient is in grade l or ll consent to participate in oral and written research Not to have internal cardiac pacemaker Not pregnancy 18 years 60 years Both having wounds, phlebitis, trauma arthritis in the massage area Having a cognitive psychomotor disorder Addiction to painkillers and opiates Cardiovascular disease Having shoulder pain before surgery K91.86 Retained cholelithiasis following cholecystectomy Treatment - Devices Treatment - Devices N/A Intervention group: Massage - Massage therapy group 30 minutes with three massage methods Petrisag-Kneading-Friction in the hand area. This technique is performed three times after cholecystectomy (4, 8 and 12 hours after surgery). Patients' pain intensity is measured and recorded 20 minutes before and after each massage with the Visual Pain Scale (VAS). Intervention group: TENS In the TENS method, electrodes are placed near or on the shoulder pain site and send the stimuli created by the device to the skin to stimulate the sensory-nerve terminals. Also, in order to achieve effective and rapid pain relief, the TENS current (frequency of 150 Hz and a pulse width of 75 μs) Used for 30 minutes. the intensity of each channel was increased until the participant was able to feel a maximal tolerable tingling sensation without causing discomfort, pain, or muscle contraction.This technique is performed three times after cholecystectomy (4, 8 and 12 hours after surgery). Patients' pain intensity is measured and recorded 20 minutes before and after each TENS with a Visual Analogue Scale (VAS). Control group: Get routine care Shoulder pain score in Visual Pain Scale Questionnaire. Timepoint: Before intervention,baseline (within 3 hours after surgery).4, 8 and 12 hours after surgery. Method of measurement: VAS Visual Analog Scale. Taking analgesic drugs. Timepoint: end of surgery. Method of measurement: check list. Time of the first dose of analgesic. Timepoint: end of surgery. Method of measurement: check list. Kermanshah University of Medical Sciences Approved 2022-01-11 Ethics Committee of Kermanshah University of Medical Sciences Building No. 2 of Kermanshah University of Medical Sciences,Shahid beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)