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IRCT20250122064489N1 IRCT 2025-02-09 Babol University of Medical Sciences The effect of mindfulness based training on pain and anxiety of knee replacement surgery The effect of mindfulness based training on intensity of pain and situational anxiety control of patient undergoing knee replacement surgery 2025-02-01 anticipated 76 Complete https://irct.ir/trial/81538 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization in the present study, the Randomization Block method will be used in the form of a double blog. The unit of randomization will be a person (we do not have stratified randomization). In a matte box, 76 cards are placed on which 38 cards have the letter A and 38 cards have the letter B written on them. so that it is not possible for anyone to see the cards inside the box. After the researcher shuffles the cards, the patients are asked to randomly pick a card from the box. If card A is taken in the intervention group, card B is taken in the control group (the selected cards do not return to the box after selection). This process continues until the sample size is completed. N/A Patients undergoing knee replacement surgery. Intervention 1: Intervention group: Four mindfulness techniques, which include: focus on breathing - body scan - visualization - mental stretching, are taught to the intervention group, and the control group receives training and routine care. In the technique of focusing on breathing, the participants are asked to close their eyes, and at the same time as a motivational text was read to them, they are taught to focus on their breathing and consciously from the nasal passage. Intermittent deep breathing for 10 minutes. In the body scanning technique, the participants are taught to focus on their breathing for 10 minutes and at the same time focus on their abdomen and then gradually shift their focus and awareness to another organ. In the visualization technique, we encourage the participants to do deep abdominal and diaphragmatic breathing and then muscle relaxation, and to imagine scenes such as the forest, the seashore, and the place of pilgrimage for 5 minutes, and show attention to the surrounding sounds and smells. In the mental stretching technique, participants are asked to perform stretching movements for 5 minutes by taking deep breaths and focusing on positive thoughts. Intervention 2: Control group: routine care before knee replacement surgery, which includes blood reservation - ICU reservation - preparation of knee prosthesis - control of vital signs - control and check of hemoglobin - performing BS, urea, na, k, pt, ptt, Esr, Crp tests - Performs ECG - Receives internal and cardiac and anesthesia service consultation. 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 Its release schedule has not yet been determined
public Maede Soleymani
No7 , 4 Golbahar Ave , 4 Golstan Ave , Azadegan Blvd , Emam Reza Street , Amol , Mazandaran
Amol Iran (Islamic Republic of) 4613658389 +98 11 4326 1686 ma.soleimani@mubabol.ac.ir Babol University of Medical Sciences scientific Maede Soleymani
No7 , Golbahar4 , Golestan4 , Azadegan 6 , Amol, Mazandaran
Amol Iran (Islamic Republic of) 4613658389 +98 11 4326 1686 ma.soleimani@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The candidate for joint replacement surgery must be unilateral and have the same treatment protocol Willingness to participate in the study Hospitalization at least one day before surgery Having the ability to listen, understand and answer your questions Not having a history of mental problems, such as not suffering from anxiety disorders listed in the patient's file Having a smart phone Having mild to moderate anxiety no limit no limit Both Incomplete completion of questionnaires Any event that leads to the removal of the sample from the action list Any event that leads to disruption of communication and understanding of the patient's pain Z44 Encounter for fitting and adjustment of external prosthetic device Other Other Intervention group: Four mindfulness techniques, which include: focus on breathing - body scan - visualization - mental stretching, are taught to the intervention group, and the control group receives training and routine care. In the technique of focusing on breathing, the participants are asked to close their eyes, and at the same time as a motivational text was read to them, they are taught to focus on their breathing and consciously from the nasal passage. Intermittent deep breathing for 10 minutes. In the body scanning technique, the participants are taught to focus on their breathing for 10 minutes and at the same time focus on their abdomen and then gradually shift their focus and awareness to another organ. In the visualization technique, we encourage the participants to do deep abdominal and diaphragmatic breathing and then muscle relaxation, and to imagine scenes such as the forest, the seashore, and the place of pilgrimage for 5 minutes, and show attention to the surrounding sounds and smells. In the mental stretching technique, participants are asked to perform stretching movements for 5 minutes by taking deep breaths and focusing on positive thoughts. Control group: routine care before knee replacement surgery, which includes blood reservation - ICU reservation - preparation of knee prosthesis - control of vital signs - control and check of hemoglobin - performing BS, urea, na, k, pt, ptt, Esr, Crp tests - Performs ECG - Receives internal and cardiac and anesthesia service consultation. Anxiety. Timepoint: Before performing the intervention and on the morning of the surgery, before performing the surgery. Method of measurement: Spielberger questionnaire. Pain. Timepoint: before intervention and on the second, third and fourteenth day after surgery. Method of measurement: McGill questionnaire. Sleep quality. Timepoint: before intervention and on the second, third and fourteenth day after surgery. Method of measurement: Pittsburgh Questionnaire. Babol University of Medical Sciences Approved 2025-01-20 Ethics committee of Babol University of Medical Sciences No. 7, 4 Golbahar Ave , 4 Golestan Ave , 6 Azadegan Blvd , Emam Reza street , Amol Town Amol Mazandaran Iran (Islamic Republic of)