Effect of massage with ostrich oil versus placebo on the severity of itching and quality of life in hemodialysis patients: a single-blind randomized clinical trial
To assess the effect of massage with ostrich oil versus placebo on the severity of itching and quality of life in hemodialysis patients
Design
This is a single-blind randomized clinical trial, phase II, in which 70 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible hemodialysis patients who will refer to Shahid Beheshti Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
History of hemodialysis for at least 6 months;
Alternating itching of the skin in day and night;
Exclusion criteria:
Open or infectious wound or cellulite;
Vascular thrombosis;
Seizure;
Paralysis of the limbs;
Using pacemaker;
History of allergic reactions
Intervention groups
Intervention group: Massage of the location of skin itching with 1 ml ostrich oil at 10 to 15 °C for 10 minutes every night for one month
Control group: Massage of the location of skin itching with 1 ml placebo oil at 10 to 15 °C for 10 minutes every night for one month
Main outcome variables
Primary outcome:
Assessing itching of the skin,
Assessing quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N237
Registration date:2018-09-27, 1397/07/05
Registration timing:prospective
Last update:2018-09-27, 1397/07/05
Update count:0
Registration date
2018-09-27, 1397/07/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage with ostrich oil versus placebo on the severity of itching and quality of life in hemodialysis patients: a single-blind randomized clinical trial
Public title
Effect of massage with ostrich oil versus placebo on the severity of itching and quality of life in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
History of hemodialysis for at least 6 months
Alternating itching of the skin in day and night
Exclusion criteria:
Open or infectious wound or cellulite
Vascular thrombosis
Seizure
Paralysis of the limbs
Using pacemaker
History of allergic reactions
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be unaware of the type of intervention. Therefore, the trial will be run as single-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.407
Health conditions studied
1
Description of health condition studied
Itching
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
Assessing itching of the skin
Timepoint
Every week after intervention for 4 weeks
Method of measurement
By history taking
2
Description
Assessing quality of life
Timepoint
One month after intervention
Method of measurement
Using the standard quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage of the location of skin itching with 1 ml ostrich oil at 10 to 15 °C for 10 minutes every night for one month
Category
Treatment - Drugs
2
Description
Control group: Massage of the location of skin itching with 1 ml placebo oil at 10 to 15 °C for 10 minutes every night for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Zahra Sadeghi Nejad
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahra63nezhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Sadeghi Nejad
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahra63nezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Karampourian
Position
MSc in Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
a.karampourian@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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
Undecided - It is not yet known if there will be 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