Determining the effect of Swedish massage on the sleep quality of patients with multiple sclerosis
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 64 patients. randomization by www.randomization.com.
Settings and conduct
The researcher will invite 64 patients to the research by visiting Ghaem hospital of Mashhad city using accessible sampling method and the participants will be divided into two groups. At the beginning of the work, the demographic information questionnaire will be completed by the research samples. Sleep quality will be measured before, after the intervention and one month after the intervention by the Pittsburgh Sleep Quality Questionnaire. In the intervention group, in addition to routine Cares, a trained member of the research team will perform Swedish massage for 8 weeks for 30 minutes.
for the group Control routine Cares will be done by health professions.
Participants/Inclusion and exclusion criteria
The inclusion conditions include suffering from MS disease (previously diagnosed by a doctor through MRI, OCT, VEP and other specialized tests); consent to enter the study; visiting the MS clinic of Ghaem Hospital in Mashhad; and the ability to complete the questionnaire.
Conditions of non-entry include non-cooperation to participate in massage therapy sessions; history of sensitivity and allergy; wound; erythema and abnormal swelling on the skin; pregnancy; history of surgery in the previous 6 months; and history of asthma and cardio-respiratory diseases.
Intervention groups
Control group: For the control group, routine procedures including joint physiotherapy, light exercise, and non-steroidal anti-inflammatory drugs will be performed by health professions.
Intervention group: in this group, in addition to routine care, Swedish massage is performed by the researcher in 5 stages.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220130053882N1
Registration date:2023-03-04, 1401/12/13
Registration timing:prospective
Last update:2023-03-04, 1401/12/13
Update count:0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
AmirReza JamshidBeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 846 0124
Email address
amir.h.r.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Swedish massage on sleep quality in patients with multiple sclerosis
Public title
The effect of Swedish massage on sleep quality in patients with multiple sclerosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing & Midwifery, Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, Mashhad University of Medical Sciences , Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.079
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Sleep quality in the Pittsburgh Questionnaire
Timepoint
Before, immediately after and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Clinic of Ghaem Hospital in Mashhad
Full name of responsible person
Amirreza Jamshidbeigi
Street address
MS Clinic of Ghaem Hospital, Ahmadabad Blvd, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
917699199
Phone
+98 51 3801 2398
Email
neuroldept@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Jamshdibeigi
Street address
University St., Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Jamshidbeigi
Position
MSc. Medical Surgical Nursing student ,Student Research Committee, Faculty of Nursing and Midwifery,
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96, Fakouri 85, Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Phone
+98 918 846 0124
Fax
Email
jamshidar4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Jamshidbeigi
Position
MSc. Medical Surgical Nursing student ,Student Research Committee, Faculty of Nursing and Midwifery,
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96, Fakouri 85, Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Phone
+98 918 846 0124
Fax
Email
jamshidar4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Jamshidbeigi
Position
Msc of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fakouri 85 St., Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Phone
+98 51 3871 0825
Email
amir.h.r.j@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD