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IRCT20221205056718N2 IRCT 2023-02-04 Ghoum University of Medical Sciences The effect of hand reflexology on pain, anxiety and hemodynamic parameters Study of the effect of hand reflexology on pain, anxiety and hemodynamic parameters in children who are candidates for surgery during Insertion of the Intravenous (IV) Catheter 2023-02-20 anticipated 88 Complete https://irct.ir/trial/68385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: children who are eligible for the study are entered into the study using the available method and are randomly assigned to two intervention and control groups using the block method (blocks of four and with an allocation ratio of 1:1 using a random number table), Blinding description: In this study, the participants will not know about the study due to their young age, and only the child's parents will know. Also, if the child refuses touch and reflexology, he will be excluded from the study. Two nurses who complete the evaluation questionnaires. And the data analyst will not know about the control and intervention groups. After the intervention, the two nurse assessors will enter the operating room and evaluate the child at the designated times. N/A anxiety. Intervention 1: Intervention group: Different parts of the hands and arms, with special attention to the areas related to the central nervous system, pituitary gland, spine, solar plexus and head reflexes of patients. For example, the middle of the thumb, which is related to the pituitary reflex, and the side that is related to the spinal reflex. This will be done using a sliding thumb motion, pressing and moving in each area. Intervention 2: Control group: In the control group, the venous route will be established without intervention and based on the routine of the department. The variables in the control group will be measured as before in the intervention group, immediately after vein extraction and 5 minutes after placing the venous catheter by the same two nurses. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The second half of 2023 To whom: There is no restriction on access to the results Conditions: There are no restrictions after de-identifying people Where to obtain: hossein sharafi tell:00989173596990 email: h_sharafi68@yahoo.com hsharafi@muq.ac.ir How to obtain: The request for the data that is irrefutably identified will be made through the e-mail introduced by the researcher, and the request will be reviewed in less than 10 days and the requested data will be provided to the requester. Comments:
public Hossein Sharafi
Qom University of Medical Sciences ,pardisan
Qom Iran (Islamic Republic of) 3749153434 009892531971087 h_sharafi68@yahoo.com Ghoum University of Medical Sciences scientific Hossein Sharafi
Pardisan,Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3749153434 +98 25 3197 1087 h_sharafi68@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 3-6 year old children Full consciousness Physiological stability Not having mental disability Decreased sensitivity to pain caused by any other disease No use of painkillers, sedatives, corticosteroids or relaxants Hospitalization for the first time Absence of pain during sampling 3 years 6 years Both Inability to place an IV line in the first attempt Child's non-cooperation during interventions F41.1 Generalized anxiety disorder Treatment - Other N/A Intervention group: Different parts of the hands and arms, with special attention to the areas related to the central nervous system, pituitary gland, spine, solar plexus and head reflexes of patients. For example, the middle of the thumb, which is related to the pituitary reflex, and the side that is related to the spinal reflex. This will be done using a sliding thumb motion, pressing and moving in each area Control group: In the control group, the venous route will be established without intervention and based on the routine of the department. The variables in the control group will be measured as before in the intervention group, immediately after vein extraction and 5 minutes after placing the venous catheter by the same two nurses. Pain related to Reflexology. Timepoint: Before, immediately and 5 minutes after the intervention. Method of measurement: Face, Legs, Activity, Cry, Consolability scale. Anxiety related to Reflexology. Timepoint: Before, immediately and 5 minutes after the intervention. Method of measurement: Modified Yale Preoperative Anxiety Scale. Hemodynamic parameters. Timepoint: Before, immediately and 5 minutes after the intervention. Method of measurement: Digital heart monitoring system. Ghoum University of Medical Sciences Approved 2023-01-30 Research Ethics Committees of Qom University of Medical Sciences No. 83, Safashehr St., Shahid Lotfi Niaser- Shahid Lotfi Niaser Alley, Safashehr Street, Qom Qom Ghoum Iran (Islamic Republic of)