Determining the effect of Swedish massage on pain and sleep quality in patients with rheumatoid arthritis
Design
In this randomized clinical trial, patients were randomly divided into two groups of 30 samples.Sampling will take during 6 months.
Settings and conduct
Swedish massage will be performed in a room at Kashan Shahid Beheshti Hospital for 30 minutes for 8 weeks (first 4 weeks twice a week and second 4 weeks three times a week).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20 to 60 years,Patients with rheumatoid arthritis in hand joint, No history of hand surgery, Having the consent to participate in the study.
Exclusion criteria: Acute pain in the joints of the hand
Intervention groups
In the intervention group, Swedish massage will be performed for 30 minutes during 8 weeks (the first 4 weeks twice a week and the second 4 weeks three times a week).
In the Control group, no intervention will not perform during 8 weeks
Main outcome variables
Pain and sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N41
Registration date:2019-09-22, 1398/06/31
Registration timing:registered_while_recruiting
Last update:2019-09-22, 1398/06/31
Update count:0
Registration date
2019-09-22, 1398/06/31
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Swedish massage on pain and sleep quality in patients with rheumatoid arthritis
Public title
The effect of massage in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rheumatoid arthritis in hand joints.
The Visual Analog Scale> 4.
The pittsburg sleep quality index > 5.
No history of hand surgery.
Age 18–65 years
Having the consent to participate in the study.
Exclusion criteria:
Acute pain in the joints of the hand.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be available (selection among patients with hand rheumatoid arthritis) and based on inclusion criteria. Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using on an line randomizer tool (https://www.randomizer.org).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ravand Street, Kashan University of Medical Sciences.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.029
Health conditions studied
1
Description of health condition studied
Swedish massage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of Pain
Timepoint
Before, after and one month after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Quality of sleep
Timepoint
Before,after and one month After intervention
Method of measurement
Pittsburg sleep quality questionnaire
Intervention groups
1
Description
Intervention group:Swedish massage will receive for 8 weeks (first 4 weeks twice a week and second 4 weeks three times a week) for 30 minutes.
Category
Treatment - Other
2
Description
Control group: Routine care including joint physiotherapy, light exercise, non-steroidal anti-inflammatory drugs will be performed for patients by health personnel .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Kashan Shahid Beheshti Hospital
Full name of responsible person
Neda Mirbagher
Street address
Ravand street,Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravand Street, Kashan University Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
salam_20012003@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
salam_20012003@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
salam_20012003@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
salam_20012003@yahoo.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available