]>
IRCT20110906007494N36 IRCT 2021-01-31 Sari University of Medical Sciences Acupressure in patients with pre-diabetes The effect of self-acupressure education on blood glucose index and anxiety in patients with pre-diabetes 2021-04-21 anticipated 88 Complete https://irct.ir/trial/45777 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible patients were randomly assigned to two groups of 44 acupressure with metformin, sham with metformin , groups using random numbers provided with computer software and Randomization Permuted Block. 22 blocks with size 4 so that there are 2 people in each block. Therefore, 88 envelopes are designed and embedded inside based on information obtained from the computer program of letters A of acupressure group, B of sham group. The priority of opening the envelope is executed on the order of the number based on the patient's admission date. N/A Pre-diabetes and Anxiety. Intervention 1: Acupressure with metformine group: After introducing and stating the aims of the study and obtaining written informed consent and patient cooperation to complete the study and after filling out the questionnaire, the researcher will learn how to pressure the points of interest. In this study a demographic and medical information questionnaire and a blood glucose index checklist were recorded. Then the subjects are positioned backwards, with the head 30 degrees above the shoulders, and the thumbs are positioned bilaterally on the SP6 point (4 fingers above the medial ankle). Massage in a clockwise and counterclockwise manner. For reduce anxiety, massage the p6 point for 5 minutes daily. Then, to ensure patient learning, the patient is massaged several times to allow the researcher to learn from the patient, and the rest is massaged. Pressure duration of 5 minutes for each point and every day of the week (5 minutes on both feet) with 10 seconds of massage and 2 seconds of rest, totaling 21 minutes (1 minute of 2 seconds rest between Massage is the point), performed for 12 consecutive weeks (18). Blood glucose and hemoglobin glycolysis and anxiety indices were measured and recorded in a laboratory before and after the intervention for 12 weeks. Intervention 2: Intervention group2: In the sham with metformine group, the procedure will be exactly the same as that of the test group, except that pressure is applied at points close to the acupressure points according to accredited acupuncture specialists in the field, who do not place this on the meridian. The order of pressure, mode of pressure, position of the patient, time, and amount of pressure in the test and sham groups were the same. It should be noted that in both groups, the pressure procedure will be taught by one person (the researcher). Blood glucose and glycated hemoglobin are then measured before and 12 weeks after baseline. No - There is not a plan to make this available Justification or reason for not sharing IPD is The research team has not yet made a decision on this issue.
public Dr. Masoumeh Bagheri Nasami
Research Assistant of Mazandaran University of Medical Sciences.Sari.Iran
sari Iran (Islamic Republic of) 48157-33971 +98 11 3379 5508 Mbagheri@mazums.ac.ir Sari University of Medical Sciences scientific Dr. Masoumeh Bagheri Nasami
Research Assistant of Mazandaran University of Medical Sciences.Sari. Iran.
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3379 5508 Mbagheri@mazums.ac.ir Sari University of Medical Sciences Iran (Islamic Republic of) Having a definitive diagnosis of pre-diabetes - Having written and verbal consent to participate in the study - Over 18 years of age - Ability to communicate, absence of clear and clinically confirmed neuropathy - Not known mental illness under treatment - Absence of ulcer, Defects, allergies, and fractures in acupuncture targeted areas - Failure to participate in other interventional studies - Pregnancy and lactation (risk of miscarriage) - No other serious illnesses - No liver disease, kidney disease And heart failure 18 years no limit Both Desire to Exclude from the Study - Improper Massage - Illness and Patient Death During Study - Hospitalization and Change of Medication - Presence of Clear and Confirmed Neuropathy During Study - No adherence of Metformin Pills E08 Diabetes mellitus due to underlying condition Prevention Placebo Acupressure with metformine group: After introducing and stating the aims of the study and obtaining written informed consent and patient cooperation to complete the study and after filling out the questionnaire, the researcher will learn how to pressure the points of interest. In this study a demographic and medical information questionnaire and a blood glucose index checklist were recorded. Then the subjects are positioned backwards, with the head 30 degrees above the shoulders, and the thumbs are positioned bilaterally on the SP6 point (4 fingers above the medial ankle). Massage in a clockwise and counterclockwise manner. For reduce anxiety, massage the p6 point for 5 minutes daily. Then, to ensure patient learning, the patient is massaged several times to allow the researcher to learn from the patient, and the rest is massaged. Pressure duration of 5 minutes for each point and every day of the week (5 minutes on both feet) with 10 seconds of massage and 2 seconds of rest, totaling 21 minutes (1 minute of 2 seconds rest between Massage is the point), performed for 12 consecutive weeks (18). Blood glucose and hemoglobin glycolysis and anxiety indices were measured and recorded in a laboratory before and after the intervention for 12 weeks. Intervention group2: In the sham with metformine group, the procedure will be exactly the same as that of the test group, except that pressure is applied at points close to the acupressure points according to accredited acupuncture specialists in the field, who do not place this on the meridian. The order of pressure, mode of pressure, position of the patient, time, and amount of pressure in the test and sham groups were the same. It should be noted that in both groups, the pressure procedure will be taught by one person (the researcher). Blood glucose and glycated hemoglobin are then measured before and 12 weeks after baseline. Blood sugar indices. Timepoint: Before and 12 weeks after intervention. Method of measurement: Anxiety questionnaire and blood test. Mazandaran University of Medical Sciences Approved 2020-02-26 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran. SARI Mazandaran Iran (Islamic Republic of)