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IRCT20250607066101N2 IRCT 2025-10-20 Khomein University of Medical Sciences Effect of acupressure on sleep and fatigue in diabetic neuropathy Investigation of the Effect of Acupressure on Sleep Quality and Fatigue in Patients with Diabetic Neuropathy 2025-10-22 anticipated 66 Complete https://irct.ir/trial/86342 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomly assigned to the intervention and control groups using a coin toss method.", Blinding description: In this study, for blinding purposes, sham points will be used for the control group. These points are located near the main points used in the intervention group but do not have therapeutic effects. This approach is intended to maintain participant blinding and allow for a more accurate assessment of the intervention's effects. N/A Diabetic neuropathy. Intervention 1: Intervention group: The intervention consists of home-based acupressure for diabetic neuropathy patients. It involves pressing specific foot points with the thumb at a rate of two rotations per second for 26 minutes, three times a week, over four weeks. The selected points aim to reduce fatigue and improve sleep quality. The applied pressure ranges from 3 to 5 kilograms and is administered by a trained researcher. Intervention 2: Control group: The intervention is similar to group 1 but pressure is applied on sham points with no therapeutic effect, serving as placebo control. 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 additional information.
public Marzieh Mousivand
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mousiavandmarzieh@gmail.com Khomein University of Medical Sciences scientific Dr. Mahdi Safarabadi
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Participants must be aged between 40 and 79 years. Participants must have type 2 diabetes. Diabetes diagnosis must be confirmed and registered at the health center. HbA1c level in adults must be below 7%. In elderly patients or those with a high risk of hypoglycemia, HbA1c should be below 8% to maintain safety. Peripheral neuropathy must be confirmed by diagnostic tests. Pittsburgh Sleep Quality Index score indicating poor sleep must be greater than 6. Total fatigue questionnaire score must be equal to or greater than 60. Physical fatigue score must be equal to or greater than 9. Mental fatigue score must be equal to or greater than 9. Reduced motivation score must be equal to or greater than 9. Reduced activity score must be equal to or greater than 10. General fatigue score must be equal to or greater than 11. Participant must be able to complete the questionnaire. Participant must provide informed consent to participate in the study. 40 years 75 years Both Neurological disorders unrelated to the study (e.g., Multiple Sclerosis, spinal cord injury). Presence of any active foot wound or skin lesion that interferes with the intervention. Current use of medications that affect sleep or fatigue. History of injury or surgery in the lower limbs. History of stimulant drug use. Pregnancy or lactation. History of alcohol consumption. Participation in similar interventions (e.g., massage therapy, physiotherapy) during the past three months. E08.21 Diabetes mellitus due to underlying condition with diabetic nephropathy Rehabilitation Placebo Intervention group: The intervention consists of home-based acupressure for diabetic neuropathy patients. It involves pressing specific foot points with the thumb at a rate of two rotations per second for 26 minutes, three times a week, over four weeks. The selected points aim to reduce fatigue and improve sleep quality. The applied pressure ranges from 3 to 5 kilograms and is administered by a trained researcher. Control group: The intervention is similar to group 1 but pressure is applied on sham points with no therapeutic effect, serving as placebo control. Sleep Quality. Timepoint: The primary outcome measurement time points in this study include assessing sleep quality at baseline (before intervention) and at the end of weeks 1, 2, 3, and 4 of the intervention. Method of measurement: In this study, sleep quality is measured using the Pittsburgh Sleep Quality Index questionnaire. This questionnaire consists of 19 items assessing sleep quality across seven dimensions, including subjective sleep quality, sleep duration, and sleep disturbances. Fatigue. Timepoint: It is at the beginning (before the intervention starts) and at the end of the first, second, third, and fourth weeks of the intervention. Method of measurement: Fatigue is assessed using the Multidimensional Fatigue Inventory questionnaire. Khomein University of Medical Sciences Approved 2025-09-20 Khomein University of Medical Sciences Ethics Committee Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran Khomein Markazi Iran (Islamic Republic of)