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IRCT20190729044370N2 IRCT 2022-06-18 Arak University of Medical Sciences The effect of plantar reflexology on pain, anxiety and physiological parameters The effect of plantar reflexology on pain, anxiety and physiological parameters of patients undergoing extracorporeal lithotripsy 2022-07-02 anticipated 74 Complete https://irct.ir/trial/64103 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the gradual entry of samples into the research in this study, Among the available patients, patients with equal number of members are assigned to each of the intervention and control groups by a blocked randomization design . 3 The effect of plantar reflexology on pain, anxiety and physiological parameters. Control group: In the control group, only routine care is performed. 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 There is no plan yet on how to share. At the end of the study, the necessary data will definitely be released.
public Zahra Borzabadi Farahani
Arak University of medical science, Basij Square, Arak,
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 86 3383 8229 farahani.z201625@gmail.com Arak University of Medical Sciences scientific Zahra Borzabadi Farahani
Arak university of medical science, Basij Square, Arak,
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 86 3383 8229 farahani.z201625@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Signing the informed consent form Age range 18 to 65 years Perform extracorporeal lithotripsy for the first time Lack of previous experience or knowledge of the effects of acupressure Full consciousness, no mental, visual and auditory disorders No history of taking anti-anxiety and sedative drugs one week before participating in the study (based on the contents of the file) No drug addiction Have a minimum literacy to complete the questionnaire; No obstruction at the site of pressure (wounds, skin diseases, etc.) Absence of sensory and motor disorders in the legs and minimal ability to walk on the legs (peripheral neuropathy or vascular problems in the lower extremities) Lack of sensitivity to olive oil Body mass index (BMI) between 18.5 to 30 kg/m2 Have an anxiety score of 43 or higher on the Spielberger scale 18 years 65 years Both Failure to complete the patient procedure for any reason unwillingness to continue the intervention Other Control group: In the control group, only routine care is performed Anxiety: Anxiety score in Spielberger questionnaire. Timepoint: Anxiety measurement will be done before and one hour after the start of the intervention. Method of measurement: The Spielberger Anxiety Inventory will be used to assess patients' anxiety. This questionnaire includes separate self-assessment scales to measure overt and covert anxiety. Pain: Pain intensity from 0 to 10. Timepoint: Pain measurement will be done before and after the start of the intervention. Method of measurement: The numerical pain scale is numbered from 0 to 10 (0 without pain and 10 maximum pain). Physiological parameters of patients including heart rate, respiration, systolic and diastolic blood pressure. Timepoint: physiological parameters measurement will be done before and after the start of the intervention. Method of measurement: To measure the pulse rate and oxygen saturation of arterial blood with a pulse oximeter and to measure the number of breaths, after observing a complete respiratory cycle, including inhalation and exhalation, we count the number of breaths and to measure blood pressure use a sphygmomanometer. Arak University of Medical Sciences Approved 2022-05-17 کمیته اخلاق دانشگاه علوم پزشکی اراک اراک - خیابان شهید شیرودی - خیابان علم الهدی Arak Markazi Iran (Islamic Republic of)