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IRCT20260630070019N2 IRCT 2026-08-10 Fasa University of Medical Sciences Effect of Acupressure in Multiple Sclerosis Patients The Effect of Acupressure on Physical and Psychological Problems in Multiple Sclerosis Patients 2018-12-22 anticipated 70 Complete https://irct.ir/trial/92100 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method of randomization: Block randomization with a block size of 4. In this method, each block contains an equal number of allocations to the intervention and control groups (two participants per group per block). This ensures that the sample sizes in both groups remain balanced throughout the recruitment process. Unit of randomization: The unit of randomization is the individual patient. Randomization strata: This study uses stratification to ensure comparability between groups at baseline. The participants will be stratified (matched) based on the following variables: Age at diagnosis Gender This means that within each stratum (e.g., "males aged 30-40"), separate block randomization sequences will be generated to ensure that these key confounding variables are equally distributed between the intervention and control groups, Blinding description: In this trial, the blinding is designed as a single-blind study. Specifically, the data analyst will be blinded to the group allocation (intervention or control) of the participants. This blinding will be maintained throughout the entire data analysis phase until the final statistical interpretations are completed. Due to the nature of the intervention (acupressure performed by patients themselves at home), it is not feasible to blind the participants or the trainer who teaches the technique. However, to minimize the risk of bias in the analytical phase—one of the most critical stages of the research—the data analyst will remain unaware of the group identities. The data will be provided to the analyst using numerical codes, and the allocation key will not be disclosed to them until all statistical analyses are finalized. This approach ensures objective and unbiased data interpretation. N/A Multiple Sclerosis (MS) is a chronic autoimmune disorder of the central nervous system. In this condition, the immune system attacks the protective myelin sheath surrounding nerve fibers in the brain, optic nerves, and spinal cord .. Intervention 1: Intervention group: Patients in this group receive acupressure training and perform the technique at home for 4 weeks. The acupressure is applied on three acupoints: HT-7 (Shenmen point), Ki-3 (Taixi point), and Yintang (Third Eye point). The intervention is performed three times per week (Saturdays, Mondays, and Wednesdays) for 4 consecutive weeks. For HT-7 and Ki-3 points, patients use specialized acupressure bracelets and ankle bands that apply continuous pressure for 30 minutes at each point. For the Yintang point, patients use their thumb or index finger to apply pressure for 10 minutes. The technique is taught in a single face-to-face session by an expert in acupressure therapy, and educational pamphlets are provided for home use. Patients receive daily reminders through a social network application (Soroush) or telephone calls to ensure adherence. The intervention aims to reduce depression, anxiety, fatigue, and improve sleep quality and quality of life in patients with multiple sclerosis. Intervention 2: Control group: Patients in this group do not receive any acupressure intervention. They continue to receive their routine standard care and medical treatments as prescribed by their physicians. No specific behavioral intervention is provided during the 4-week study period. However, at the end of the study, if the acupressure technique proves to be effective, the control group participants will be offered the opportunity to receive the acupressure training as an ethical consideration. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (all collected outcome measures). When: 6 months after publication, available for 5 years. To whom: Researchers from academic institutions. Conditions: Approved research proposal and signed data sharing agreement. Where to obtain: Principal Investigator via email. How to obtain: Submit request → Review by PI and ethics committee (4-6 weeks) → Sign agreement → Data transfer. Total: 3-4 months. Comments: Requests reviewed case by case.
public Faezeh Abadi
Ebn sina square
Fasa Iran (Islamic Republic of) ۷۴۶۱۶-۸۶۶۸۸ +98 71 5335 0994 faeze.abadi@yahoo.com Fasa University of Medical Sciences scientific zhila fereydoni
Ebn sina square
Fasa Iran (Islamic Republic of) ۷۴۶۱۶-۸۶۶۸۸ +98 71 5335 0994 faeze.abadi@yahoo.com Fasa University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 50 years. Definite diagnosis of Multiple Sclerosis (MS) for at least one year. Not being in the acute relapse or progressive phase of the disease. No other acute or chronic physical, mental, or psychological disorders. No history of acupressure therapy. Not taking sedatives, antidepressants, hypnotics, or anxiolytic medications. Being conscious and alert. Stable hemodynamic status. No local skin problems at acupoints (e.g., wound, burn, abscess, cyst). No history of substance abuse. Providing written informed consent. Pittsburgh Sleep Quality Index score greater than 5. Literacy (at least 6 years of education) to complete the Beck questionnaire. No visual or auditory impairments. 18 years 50 years Both Inconsistent or non-completion of acupressure sessions. Withdrawal of consent to continue participation in the study. Development of a serious physical or psychological disorder during the study. G35 Multiple sclerosis Other Other Intervention group: Patients in this group receive acupressure training and perform the technique at home for 4 weeks. The acupressure is applied on three acupoints: HT-7 (Shenmen point), Ki-3 (Taixi point), and Yintang (Third Eye point). The intervention is performed three times per week (Saturdays, Mondays, and Wednesdays) for 4 consecutive weeks. For HT-7 and Ki-3 points, patients use specialized acupressure bracelets and ankle bands that apply continuous pressure for 30 minutes at each point. For the Yintang point, patients use their thumb or index finger to apply pressure for 10 minutes. The technique is taught in a single face-to-face session by an expert in acupressure therapy, and educational pamphlets are provided for home use. Patients receive daily reminders through a social network application (Soroush) or telephone calls to ensure adherence. The intervention aims to reduce depression, anxiety, fatigue, and improve sleep quality and quality of life in patients with multiple sclerosis. Control group: Patients in this group do not receive any acupressure intervention. They continue to receive their routine standard care and medical treatments as prescribed by their physicians. No specific behavioral intervention is provided during the 4-week study period. However, at the end of the study, if the acupressure technique proves to be effective, the control group participants will be offered the opportunity to receive the acupressure training as an ethical consideration. Mean score of depression as measured by the Beck Depression Inventory (BDI). This 21-item self-report instrument measures the severity of depressive symptoms over the past two weeks. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater severity of depression. The primary outcome is the mean change in BDI score from baseline to post-intervention. Timepoint: Baseline (before the start of the intervention) and immediately after the 4-week intervention period (Week 4). Method of measurement: Beck Depression Inventory (BDI) - a 21-item self-report questionnaire. Mean score of anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI) - Trait scale. This 20-item self-report instrument measures the general tendency to experience anxiety across different situations. Each item is scored from 1 to 4, with total scores ranging from 20 to 80. Higher scores indicate higher levels of anxiety. The primary outcome is the mean change in STAI score from baseline to post-intervention. Timepoint: Baseline (before the start of the intervention) and immediately after the 4-week intervention period (Week 4). Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI) - Trait scale, a 20-item self-report questionnaire. Mean score of fatigue as measured by the Fatigue Severity Scale (FSS). This 9-item self-report instrument assesses the severity of fatigue and its impact on daily functioning. Each item is scored from 1 to 7, with the total score calculated as the mean of all items. Total scores range from 1 to 7, with higher scores indicating greater fatigue severity. The primary outcome is the mean change in FSS score from baseline to post-intervention. Timepoint: Baseline (before the start of the intervention) and immediately after the 4-week intervention period (Week 4). Method of measurement: Fatigue Severity Scale (FSS) - a 9-item self-report questionnaire. Mean score of sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). This 19-item self-report instrument assesses sleep quality and disturbances over a one-month period across seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each domain is scored from 0 to 3, with a global PSQI score ranging from 0 to 21. A global score of 5 or higher indicates poor sleep quality. The primary outcome is the mean change in PSQI global score from baseline to post-intervention. Timepoint: Baseline (before the start of the intervention) and immediately after the 4-week intervention period (Week 4). Method of measurement: Pittsburgh Sleep Quality Index (PSQI) - a 19-item self-report questionnaire. Mean score of quality of life as measured by the SF-36 Health Survey Questionnaire. This 36-item self-report instrument assesses health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better quality of life. Domain scores are aggregated into two summary component scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). The primary outcome is the mean change in SF-36 domain scores from baseline to post-intervention. Timepoint: Baseline (before the start of the intervention) and immediately after the 4-week intervention period (Week 4). Method of measurement: SF-36 Health Survey Questionnaire - a 36-item self-report questionnaire. Fasa University of Medical Sciences Approved 2019-11-29 Ethics committee of Fasa university of medical science Ebn sina square Fasa Fars Iran (Islamic Republic of)