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IRCT20220130053882N1 IRCT 2023-03-04 Mashhad University of Medical Sciences The effect of Swedish massage on sleep quality in patients with multiple sclerosis The effect of Swedish massage on sleep quality in patients with multiple sclerosis 2023-04-04 anticipated 64 Complete https://irct.ir/trial/67080 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization type: block Block size: 4 pieces Randomization Unit: Individual Randomization Tool: It is done by creating a random sequence of numbers using an online tool (https://www.randomizer.org). Concealment: Using sealed opaque envelopes How people enter the random chain: people are entered into the random sequence in the order of entering the study, Blinding description: The analyst will be unaware of the intervention and control groups. N/A Multiple sclerosis. Intervention group: Two Male and Female researchers who have a Swedish professional massage certificate will perform this intervention. 30-minute Swedish massage is performed for a total of 8 weeks in the intervention group. In the first 4 weeks, the massage is done twice a week and in the second 4 weeks, the massage is done three times a week. According to the request and convenience of the participants, the massage is done in the morning or in the evening. All participants in the intervention and control groups will receive usual MS care and treatment. A private room in Ghaem Hospital's MS Clinic will be used for intervention sessions. The room temperature will be set between 22 and 24 degrees Celsius and the humidity between 40 and 60 percent. The participant is placed in a supine position with the head elevated at 30 degrees. Swedish massage is applied. Field et al.'s protocol will be used to perform massage in five stages in the intervention group: Stage 1. effleurage Step 2. Petrissage Step 3. vibration Step 4. Tapotation Step 5. Friction. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Amirreza Jamshidbeigi
No. 96, Fakouri 85, Rezashahr
Mashhad Iran (Islamic Republic of) 9176943314 +98 918 846 0124 jamshidar4001@mums.ac.ir Mashhad University of Medical Sciences scientific Amirreza Jamshidbeigi
No. 96, Fakouri 85, Rezashahr
Mashhad Iran (Islamic Republic of) 9176943314 +98 918 846 0124 jamshidar4001@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Suffering from MS disease (previously diagnosed by a doctor through MRI, OCT, VEP and other specialized tests) Refer to the MS clinic of Ghaem Hospital in Mashhad Parents/primary caregivers or participants if they are 18 years old or older present at the time of registration to complete the questionnaire and complete the informed consent form; Farsi speaking and developmentally able to read and/or understand the questionnaire Consent to participate in the study no limit no limit Both Non-cooperation to participate in massage therapy sessions History of sensitivity and allergy Ulcers, erythema and abnormal bumps on the skin Pregnancy History of surgery in the previous 6 months History of asthma and cardio-pulmonary diseases G35 Multiple sclerosis Treatment - Other Intervention group: Two Male and Female researchers who have a Swedish professional massage certificate will perform this intervention. 30-minute Swedish massage is performed for a total of 8 weeks in the intervention group. In the first 4 weeks, the massage is done twice a week and in the second 4 weeks, the massage is done three times a week. According to the request and convenience of the participants, the massage is done in the morning or in the evening. All participants in the intervention and control groups will receive usual MS care and treatment. A private room in Ghaem Hospital's MS Clinic will be used for intervention sessions. The room temperature will be set between 22 and 24 degrees Celsius and the humidity between 40 and 60 percent. The participant is placed in a supine position with the head elevated at 30 degrees. Swedish massage is applied. Field et al.'s protocol will be used to perform massage in five stages in the intervention group: Stage 1. effleurage Step 2. Petrissage Step 3. vibration Step 4. Tapotation Step 5. Friction Sleep quality in the Pittsburgh Questionnaire. Timepoint: Before, immediately after and one month after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Mashhad University of Medical Sciences Approved 2022-10-04 Research Ethics Committees of School of Nursing & Midwifery, Mashhad University of Medical Sciences Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, Mashhad University of Medical Sciences , Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)