The Effect of Acupressure on Physical and Psychological Problems in Multiple Sclerosis Patients

To determine the effect of acupressure on physical and psychological outcomes in patients with multiple sclerosis.

A single-blind, parallel-group, randomized controlled trial with a block randomization design (block size of 4). The target sample size is 70 participants (35 per group). Randomization will be stratified by age at diagnosis and gender. Allocation concealment will be performed using sequentially numbered, sealed opaque envelopes.

Eligible patients will be recruited and randomly allocated to either the intervention or control group. The intervention group will receive acupressure training in a face-to-face session and perform the technique at home for 4 weeks, with follow-up via social network (Soroush app) or telephone calls. Outcomes (depression, anxiety, fatigue, sleep quality, and quality of life) will be assessed using validated questionnaires (Beck Depression Inventory, Spielberger State-Trait Anxiety Inventory, Fatigue Severity Scale, Pittsburgh Sleep Quality Index, and SF-36) at baseline and immediately after the 4-week intervention period.

Inclusion criteria: Age 18-50 years; confirmed diagnosis of MS for at least one year;... Exclusion criteria: Inconsistent completion of acupressure sessions;...

Intervention group: Patients perform acupressure on three acupoints (HT-7/Shenmen, Ki-3, and Yintang/Third Eye) for 4 weeks, three times per week Control group: Patients receive no acupressure intervention and continue their routine care.

Mean change in depression score (Beck Depression Inventory) Mean change in anxiety score (Spielberger State-Trait Anxiety Inventory) Mean change in fatigue score (Fatigue Severity Scale) Mean change in sleep quality score (Pittsburgh Sleep Quality Index) Mean change in quality of life score (SF-36 Questionnaire)

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.

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.

De-identified individual participant data (all collected outcome measures).

6 months after publication, available for 5 years.

Researchers from academic institutions.

Approved research proposal and signed data sharing agreement.

Principal Investigator via email.

Submit request → Review by PI and ethics committee (4-6 weeks) → Sign agreement → Data transfer. Total: 3-4 months.

Requests reviewed case by case.