Protocol summary

Study aim
Comparison of the effect of slow stroke back massage and acupressure on skin itching in hemodialysis patients
Design
Randomized clinical trial with two intervention parallel groups, without blinding, on 54 patients. Random Allocation software site will be used for randomization.
Settings and conduct
The hemodialysis ward of Mehr and 17 Shahrivar hospitals in Mashhad has been selected as the sampling location. 54 patients with pruritus are admitted to the study with satisfaction and will be placed in the group of massage or acupressure based on random allocation. For each group, the necessary forms and questionnaires will be completed at specified intervals and interventions will be performed for 12 sessions of 5-10 minutes after hemodialysis.
Participants/Inclusion and exclusion criteria
willingness to participate in the study, visual, auditory and alert ability to answer questions, undergoing hemodialysis for at least 6 months, referring to hemodialysis 3 sessions 3 to 4 hours a week, no liver disease, No amputation in the lower and upper limbs, mild to severe itching based on the visual scale of itching and a score between 1 and 10 at least 2 weeks before the test, no itchy skin lesions, body temperature between 36.5 to 37.5 ° C , No open wound or infection in the intervention area, dialysis solution temperature between 36.5 to 37.5 ° C, no use of traditional medicine to relieve itching 1 week before the test and age between 18 to 80 years
Intervention groups
Group A: Perform 12 sessions of slow stroke massage from the neck to the sacral area, 3 sessions per week and 10 minutes per session Group B: Perform 12 sessions of acupressure in points LI 11 and SP 10, 3 sessions per week and each session for 5 minutes at each point
Main outcome variables
Itching of the skin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200727048223N1
Registration date: 2020-09-29, 1399/07/08
Registration timing: prospective

Last update: 2020-09-29, 1399/07/08
Update count: 0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Sina Salati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
salatis982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison slow stroke back massage and acupressure effect on skin pruritus in hemodialysis patients
Public title
The effect of massage and acupressure on skin itching
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Acceptable visual, auditory and consciousness ability to answer questions Undergoing hemodialysis for at least 6 months Referring to hemodialysis 3 sessions 4 hours a week The presence of mild to severe skin itching based on the visual scale of itching and a score between 1 to 10 at least 2 weeks before the test Dialysis solution temperature between 36.5 to 37.5 ° C Age between 18 to 80 years
Exclusion criteria:
liver diseases Amputation in the lower and upper limbs Existence of any itchy skin lesions Existence of open wound or infection in the intervention area Use traditional medicine to relieve itching 1 week before the test Body temperature above 37.8 ° C
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the permutation block method was used to generate a sequence of random allocation of samples(by individual) to the study groups. Random allocation sequences were performed using randomization software and block size two. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks is selected at random. If the first block, AB, is selected, the first person is assigned to group A and the second person to group B. And this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers.
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 Mashhad University of Medical Sciences
Street address
Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.030

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

2

Description of health condition studied
skin pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified

Primary outcomes

1

Description
Itching of the skin
Timepoint
Measurement of skin itching at the beginning of the study, weekly and at the end of the study after massage and acupressure interventions
Method of measurement
Yosipovitch Itching Questionnaire

Secondary outcomes

1

Description
The effect of itchy skin on daily activities
Timepoint
At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure
Method of measurement
Yosipovitch pruritus questionnaire

2

Description
Effect of skin itching on sleep
Timepoint
At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure
Method of measurement
Yosipovitch pruritus questionnaire

3

Description
Effect of skin itching on quality of life
Timepoint
At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure
Method of measurement
Yosipovitch pruritus questionnaire

4

Description
Emotional skin itching dimension
Timepoint
At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure
Method of measurement
Yosipovitch pruritus questionnaire

5

Description
Skin itching severity
Timepoint
At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure
Method of measurement
Yosipovitch pruritus questionnaire

6

Description
Location of itching
Timepoint
At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure
Method of measurement
Yosipovitch pruritus questionnaire

Intervention groups

1

Description
Intervention group: Perform 12 sessions of slow stroke massage from the neck to the sacral area, 3 sessions per week and 10 minutes per session
Category
Treatment - Other

2

Description
Intervention group: Perform 12 sessions of acupressure in points (LI 11 at the outer end of the cubital) and (SP 10 in the area above the upper corner of the patella of the knee) 3 sessions per week and each session for 5 minutes at each point
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr hospital
Full name of responsible person
Qolam-reza Faroudi
Street address
Mehr hospital,Alandasht sqr ,Kouhsangi Avenue,Mashhad,Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3842 7014
Email
pr@mehrhospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
MoradiH3@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
Tayebe Pourghaznein
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery,Daneshgah Ave., Ibn Sina Ave., Khorasan Razavi, Mashhad,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
38591511 051
Email
PourghazneinT@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebe Pourghaznein
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery,Daneshgah Ave., Ibn Sina Ave., Khorasan Razavi, Mashhad,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
PourghazneinT@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sina Salati
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery faculty, Mashhad, Daneshgah Ave, Ibn-sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13199
Phone
+98 51 3859 1511
Fax
Email
salatis982@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
In this study, all participants' data (demographic information, laboratory indicators and questionnaire scores) will be available after being identified.
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Academic researchers will be able to submit requests for data, and all quantitative and qualitative inferential and analytical analyzes of the data will be allowed.
From where data/document is obtainable
Sina salati . salatis982@mums.ac.ir Tayebe Pourghaznein. PourghazneinT@mums.ac.ir
What processes are involved for a request to access data/document
The applicant must write a formal application to the corresponding author, announcing his application. After approval and coordination with the Vice Chancellor for Research, the study data will be sent to the applicant formally and confidentially.
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