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IRCT20260720070275N1 IRCT 2026-08-26 Shahed University Comparison of the effect of foot and hand reflexology massage on pain intensity and sleep quality in patients undergoing total knee arthroplasty Comparison of the effect of foot and hand reflexology massage on pain intensity and sleep quality in patients undergoing total knee arthroplasty 2026-08-23 anticipated 105 Recruiting https://irct.ir/trial/91787 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible patients will be assigned to groups using a block randomization method with blocks of three (each block comprising one participant for each of the three groups: foot reflexology, hand reflexology, and routine care/control). To determine the assignment sequence within each block, random numbers generated via https://www.randomizer.org will be used, with settings configured for a single set of three unique numbers and the "place markers across" option selected to define the sequence across all blocks, Blinding description: The assessment and analysis of the results will be performed by an individual who is blinded to the patients’ group allocation. N/A Condition 1: pain intensity after total knee Arthroplasty. Condition 2: Sleep Quality after total knee Arthroplasty. Intervention 1: Intervention Group 1: In addition to receiving standard care, foot reflexology massage will be performed for 10 minutes on the side ipsilateral to the operated knee. Intervention timing: 4 hours after analgesic administration (intramuscular Pethidine 50 mg) on the day of surgery upon arrival at the ward, as well as on the first and second postoperative days (for a total of 3 sessions). Intervention 2: Intervention Group 2: In addition to receiving standard care, hand reflexology massage will be performed for 10 minutes on the side ipsilateral to the operated knee. Intervention timing: 4 hours after analgesic administration (intramuscular Pethidine 50 mg) on the day of surgery upon arrival at the ward, as well as on the first and second postoperative days (for a total of 3 sessions). Intervention 3: Control Group: Receives standard care without any intervention. Pain intensity and sleep quality will be assessed at the same time points as the intervention groups: 4 hours after analgesic administration (intramuscular Pethidine 50 mg) on the day of surgery upon arrival at the ward, as well as on the first and second postoperative days. Yes - There is a plan to make this available What will be shared: Anonymized individual data—including age, gender, medical history, and education—are shared. When: Access begins after the publication of results. To whom: Individuals within the relevant scientific field who intend to study or cite the data are granted access to it. Conditions: The use of data to enhance efficiency in similar studies and to accelerate the relevant research process is approved Where to obtain: They can access the data By sending a message to the researcher's email address : alirezaoliver1380@gmail.com How to obtain: Upon the requester's application for access to the data _whether for reference or study _ the data will be sent to them at the earliest opportunity Comments:
public Nasrin Alaee
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 2133 alaei@shahed.ac.ir Shahed University scientific Nasrin Alaee
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
Tehran Iran (Islamic Republic of) 331911865 +98 21 5121 2133 alaei@shahed.ac.ir Shahed University Iran (Islamic Republic of) -Ability to understand and complete the questionnaires and measurement scales- Age over 40 years Abbreviated Mental Test Score (AMTS) of 7 or higher for elderly patients aged over 60 years 40 years no limit Both -Absence of knee joint infection, rheumatoid arthritis, or neuropathic diseases-- No history of antidepressant or anticonvulsant medication use Absence of deep vein thrombosis (DVT), open wounds, or severe varicose veins in the limb ipsilateral to the surgical knee Absence of upper or lower limb amputation on the side ipsilateral to the operated knee M25.56 G47.01 Pain in knee Insomnia due to medical condition Treatment - Other Treatment - Other Treatment - Other Intervention Group 1: In addition to receiving standard care, foot reflexology massage will be performed for 10 minutes on the side ipsilateral to the operated knee. Intervention timing: 4 hours after analgesic administration (intramuscular Pethidine 50 mg) on the day of surgery upon arrival at the ward, as well as on the first and second postoperative days (for a total of 3 sessions). Intervention Group 2: In addition to receiving standard care, hand reflexology massage will be performed for 10 minutes on the side ipsilateral to the operated knee. Intervention timing: 4 hours after analgesic administration (intramuscular Pethidine 50 mg) on the day of surgery upon arrival at the ward, as well as on the first and second postoperative days (for a total of 3 sessions). Control Group: Receives standard care without any intervention. Pain intensity and sleep quality will be assessed at the same time points as the intervention groups: 4 hours after analgesic administration (intramuscular Pethidine 50 mg) on the day of surgery upon arrival at the ward, as well as on the first and second postoperative days. Pain intensity. Timepoint: before intervention , 10 minute after intervention and the day after intervention at the morning for 3 days (total : 9 times). Method of measurement: Pain intensity will be measured using a Visual Analog Scale (VAS), where the patient indicates their pain score on a scale from 0 to 10. Sleep Quality. Timepoint: On the morning after the intervention, for three consecutive days. Method of measurement: Sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire . The questionnaire is administered to the patient in the morning to assess the previous night's sleep quality, with scores ranging from 0 (worst) to 100 (best). Shahed University Approved 2026-05-31 Ethics committee of shahed university Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)