Determining the effect of Thai Massage on sleep quality and general health in hemodialysis patients
Design
In this randomized clinical trial, patients were randomly assigned to two groups of 40 individuals.
Settings and conduct
In the test group, the intervention is in the form of a Thai Massage, with each session lasting 60 minutes, before dialysis, three times a week for four consecutive weeks (12 sessions in total) will be held at Akhavan Hospital in Kashan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Tendency to collaborate and participate in the study - Giving informed written consent - The Pittsburgh Sleep Questionnaire score > 5 - Lack of amputation, fractures, infections, wounds and skin diseases in the limbs - Have three sessions of hemodialysis per week and 3-4 hours per session - Have at least three months of hemodialysis history - Full of consciousness - No history of alcohol and drug addiction.
Exclusion Criteria:
Lack of willingness to cooperate - Not attending two massage therapy sessions - Hospitalization and creating a physical or mental crisis during the research - Taking sedatives and sleeping pills
Intervention groups
In the test group, the intervention is in the form of a Thai Massage, with each session lasting 60 minutes, before dialysis, three times a week for four consecutive weeks (12 sessions in total). There will be no intervention in the control group for 4 weeks.
Main outcome variables
Sleep quality
General health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N43
Registration date:2020-05-16, 1399/02/27
Registration timing:prospective
Last update:2020-05-16, 1399/02/27
Update count:0
Registration date
2020-05-16, 1399/02/27
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
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Thai Massage on sleep quality and general health in hemodialysis patients
Public title
The effect of massage in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to collaborate and participate in the study
Giving informed written consent
The Pittsburgh Sleep Questionnaire score > 5
Lack of amputation, fractures, infections, wounds and skin diseases in the limbs
Have three sessions of hemodialysis per week and 3-4 hours per session
Have at least three months of hemodialysis history
Full of consciousness
No history of alcohol and drug addiction
Exclusion criteria:
Lack of willingness to cooperate
Failure to attend two sessions of massage therapy
Hospitalization and creating a physical or mental crisis during the research
Taking sedatives and hypnotics
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of test and Control groups is done using quadratic random blocks method using software
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
Qutb Ravandi Boulevard. Kashan University of Medical Sciences.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.008
Health conditions studied
1
Description of health condition studied
Thai Massage
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Sleep quality score in the Pittsburgh Questionnaire
Timepoint
Before, after and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
General Health Score in the Goldberg Questionnaire
Timepoint
Before,after and one month After intervention
Method of measurement
Goldberg General Health Questionnaire
Intervention groups
1
Description
Intervention group: In the test group, the intervention is in the form of Thai Massage, with each session lasting 60 minutes, before dialysis, three times a week for four consecutive weeks (12 sessions in total).
Category
Treatment - Other
2
Description
Control group: For the control group, the usual treatment measures (hemodialysis and drug therapy) will be performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Center in Kashan Akhavan Hospital
Full name of responsible person
Neda Mirbagher
Street address
Qutb Ravandi Boulevard
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
Qutb Ravandi Boulevard
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
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
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
Qutb Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
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
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
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
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available