Determining the effect of slow stroke back massage method on sleep quality and perception of well-being of dialysis patients
Design
The present study is a clinical trial type with control and intervention groups, unblinded, random allocation using numbered cards. The sample size was calculated as 41 people (82 people in total) in each group.
Settings and conduct
Patients will be massaged from 3 to 7 pm in one of the rooms of the dialysis department where there is no disease. In the intervention group, the researcher will massage each patient three times a week for ten minutes with slow, gentle and rhythmic movements of the palms on the patient's back with a uniform speed of about 60 movements per minute and this work will continue for four weeks. .
Participants/Inclusion and exclusion criteria
Inclusion conditions
1. Age more than 18 years and less than 70 years
2. Obtaining a score of 5 and above from the Pittsburgh Sleep Quality Questionnaire 3. Patients who have at least 3 months history of dialysis, at least twice a week and for at least two hours.
Exclusion conditions
1. Suffering from heart, respiratory, liver, cancer or mental disorders such as depression 2. History of surgery and wound in the back and abdomen in the last 6 months 3. Using all kinds of complementary medicine methods during the previous three months 4. Personal use of sleeping pills, benzodiazepines, sedatives and narcotics by the patient 5. Failure to follow up to participate in massage therapy sessions
Intervention groups
In the intervention group, massage was done each three times a week for ten minutes with slow on the patient's back, about 60 movements per minute for four weeks. The control group will receive routine care during four weeks.
Main outcome variables
Sleep quality and perceived well-being score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231122060139N1
Registration date:2023-12-18, 1402/09/27
Registration timing:prospective
Last update:2023-12-18, 1402/09/27
Update count:0
Registration date
2023-12-18, 1402/09/27
Registrant information
Name
Masumeh Akbarbegloo
Name of organization / entity
Khoy University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3625 5777
Email address
m_akbarbegloo@khoyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-06, 1402/10/16
Expected recruitment end date
2024-04-04, 1403/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of back slow stroke massage on sleep quality and perceived wellbeing in dialysis patients in Khoy shahidmadani hospital 2023
Public title
The effect of back slow stroke massage on sleep quality and perceived wellbeing in dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Male and female hemodialysis patients who have medical records in Shahid Madani Khoy Hospital.2. Having the ability to communicate3. Age more than 18 years and less than 70 years4. Obtaining a score of 5 and above from the Pittsburgh Sleep Quality Questionnaire5. Patients who have a history of dialysis for at least 3 months, at least twice a week and for at least two hours.
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
After the selection of eligible people through available sampling, the patients will be randomly allocated into two intervention and control groups. The random allocation method will be such that the names of eligible hemodialysis patients in Shahid Madani Khoy Hospital are written on a number of cards selected by the researcher as the control group and the same number of cards for the intervention group; Then, by merging the cards together, one issued card is recorded and its allocation is recorded, and that card is returned to the group of other cards after being issued. Then the cards are merged again and another card is removed. This process continues until reaching a random sequence according to the sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of Khoy University of Medical Sciences
Street address
No. 35, Shahid Modarres Ave., Emam Blvd., Khoy Town
City
Khoy
Province
West Azarbaijan
Postal code
5816753464
Approval date
2023-09-18, 1402/06/27
Ethics committee reference number
IR.KHOY.REC.1402.039
Health conditions studied
1
Description of health condition studied
slow stroke back massage
ICD-10 code
Z50.9
ICD-10 code description
Care involving use of rehabilitation procedure, unspecified
Primary outcomes
1
Description
Sleep quality score in the Pittsburgh Questionnaire
Timepoint
Before, two weeks and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
The wellness perception score in the Adams perceived wellness survey
Timepoint
Before, two weeks and one month after the intervention
Method of measurement
Adams perceived wellness survey
Intervention groups
1
Description
Intervention group: In the test group, each patient will be massaged three times a week for ten minutes with slow, gentle and balanced movements of the palms on the patient's back with a uniform speed of about 60 movements per minute and this work will continue for four weeks.
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 of Shahid Madani Hospital in Khoy city
Full name of responsible person
Masumeh Akbarbegloo
Street address
No. 35, Shahid Modarres Ave., Emam Blvd., Khoy Town
City
Khoy
Province
West Azarbaijan
Postal code
5813974699
Phone
+98 44 3622 1672
Email
m_Akbarbegloo@khoyums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoy University of Medical Sciences
Full name of responsible person
Hosein Motarefy
Street address
Valiasr Ave., Khoy Town., Khoy University of Medical Sciences
City
Khoy
Province
West Azarbaijan
Postal code
5816753464
Phone
+98 44 3625 5777
Email
motarefy_h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoy 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
Khoy University of Medical Sciences
Full name of responsible person
Masumeh Akbarbegloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 35, Shahid Modarres Ave., Emam Blvd., Khoy Town
City
Khoy
Province
West Azarbaijan
Postal code
5813974699
Phone
+98 44 3622 1672
Email
m_Akbarbegloo@khoyums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoy University of Medical Sciences
Full name of responsible person
Masumeh Akbarbegloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 35, Shahid Modarres Ave., Emam Blvd., Khoy Town
City
Khoy
Province
West Azarbaijan
Postal code
5813974699
Phone
+98 44 3622 1672
Email
m_Akbarbegloo@khoyums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoy University of Medical Sciences
Full name of responsible person
Masumeh Akbarbegloo
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 35, Shahid Modarres Ave., Emam Blvd., Khoy Town
City
Khoy
Province
West Azarbaijan
Postal code
5813974699
Phone
+98 44 3622 1672
Email
m_Akbarbegloo@khoyums.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