Investigating the effect of effleurage massage and diluted vinegar solution on relieving the pruritus of hemodialysis patients in Bandar Abbas educational-treatment hospitals
Design
Each patient based on receiving a code from 0 to 60, is placed into one of groups (investigation or control) due to random number table
Settings and conduct
The study is a clinical trial and the samples were placed into two groups of intervention and control using a random number table and intervention group received the effleurage massage and diluted vinegar solution and control group received only routine care of the unit. The place of performing research was in Bandar_abbas educational-treatment hospitals .
This study was two-sided and a valuator completed the questionnaires using the patient identification and statistical analyzer analyzed the data using the group number.
Participants/Inclusion and exclusion criteria
Include:
All patients over the age of 18 who have been treated for hemodialysis for more than three months and complain of uremic urethra and dialysis three times a week and undergo hemodialysis every 3-5 hours.
Exclude:
Having massage prohibition, sensitivity to vinegar solution, lack of satisfaction, another skin problem other than uremic pruritus
Intervention groups
Intervention group receives effleurage massage and diluted vinegar solution and control group only receives routine care of the unit.
Main outcome variables
The investigation of effleurage massage and diluted vinegar solution on uremic pruritus.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160209026483N2
Registration date:2018-04-22, 1397/02/02
Registration timing:retrospective
Last update:2018-04-22, 1397/02/02
Update count:0
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3223 2142
Email address
h_khoshnou@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-07-15, 1396/04/24
Actual recruitment start date
2017-07-01, 1396/04/10
Actual recruitment end date
2017-07-15, 1396/04/24
Trial completion date
empty
Scientific title
investigating the effect of effleurage massage and diluted vinegar solution on relieving pruritus among patients undergoing hemodialysis
Public title
investigating the effect of effleurage massage and diluted vinegar solution on relieving pruritus among hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Performing hemodialysis three times a week
Age over 18 years
History of hemodialysis more than three months
Each hemodialysis session lasts for 3-5 hours
Exclusion criteria:
massage prohibition
sensitivity to vinegar solution
skin problem other than uremic pruritus
lack of patient satisfaction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
each patient entering the study received a code from 0 to 60, then the samples were divided into two groups of investigation and control using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
an evaluator who was not informed about which patient belongs to which group (intervention or control), completed the scales using the patient identification code. then the statistics analyzer analyzed the data using the group number(1,2).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍٍٍEthics Committee of Hormozgan University of Medical Sciences
Street address
South Resalat st
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
hums.rec.1396.021
Health conditions studied
1
Description of health condition studied
itching in hemodialysis patients
ICD-10 code
z49
ICD-10 code description
Preparatory care for dialysis
Primary outcomes
1
Description
uremic pruritus
Timepoint
The evaluation of pruritus score in weeks 0,1,2,3,4 of study
Method of measurement
visual analog scale
Secondary outcomes
1
Description
scale of sleep disturbance
Timepoint
Before intervention and the first, second, third and fourth weeks of the intervention
Method of measurement
The questionnaire of sleep disturbance
Intervention groups
1
Description
Intervention group: Receiving effleurage massage and then diluted vinegar solution after each turn of performing hemodialysis
Category
Other
2
Description
Control group: Receiving standard care of the unit
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital and Children Hospital in Bandar Abbas
Full name of responsible person
Zeinab Rastgoo
Street address
South Resalat st.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6368
Email
zrastgoo1362@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Doctor Teimoor Aghamolaei
Street address
ُSouth Resalat st.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6368
Email
zrastgoo1362@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Zeinab Rastgoo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
South Resalat St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6368
Email
zrastgoo1362@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Zeinab Rastgoo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
South Resalat St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6368
Email
zrastgoo1362@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Zeinab Rastgoo
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
South Resalat ُُُStreet
City
Bandar Abbas
Province
Hormozgan
Postal code
74851-33177
Phone
+98 76 3366 6368
Email
zrastgoo1362@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
main outcome information
When the data will become available and for how long
starting the access period, six month after printing the results
To whom data/document is available
researchers working in academic and scientific institutes
Under which criteria data/document could be used
those with the same study and working in research institutes
From where data/document is obtainable
zrastgoo1362@gmail.com
What processes are involved for a request to access data/document