Data collection tools: demographic questionnaire,Yosipovitch itch assessment questionnaire and educational need assessment questionnaire based on Orem self-care model. Studied interventions and study time: Researcher intervention was performed in 4 sessions of 30 minutes (at least 2 times a week) initially for three face to face sessions, and then a group meeting based on the common need for patients to solve problems and expressing experiences of each as lecture, questions and answers, pamphlets and booklets up to a month in the intervention group.
At the end of each session, the time of next training session was determined due to the patient condition (patient consent and taking into account the physical condition) and educational pamphlets regarding the same session were distributed among samples and the complete booklet was given to the patients at the end of intervention. Primary outcome: Uremic pruritus
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041625852N2
Registration date:2016-05-03, 1395/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Tayebeh Khosravipour
Name of organization / entity
School of Nursing and Midwifery Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 939 536 8392
Email address
t_khosravi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Orem self care on uremic pruritus in hemodialysis patients
Public title
The effect of Orem self care program on uremic pruritus in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
1. They must be between 18-60 years old. 2. At least 2 months have passed since their first hemodialysis. 3. They should be dialyzed by bicarbonate solution. 4. They should be dialyzed by using polysulfone filters. 5. Despite intaking anti-itch medication, they still suffer itching. 6. Apart from uremic pruritus, they have no skin problem. 7. They don’t suffer liver, active biliary and polycythemia diseases (according to monthly test results of patient and according to the specialist). 8. They should not suffer cognitive problems or debilitating diseases. 9. They should be able to understand conversation in Farsi and communicate.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin , Tehran, Iran
City
Tehran
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
sbmu2.REC.1394.16.1
Health conditions studied
1
Description of health condition studied
uremic pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
Primary outcomes
1
Description
Uremic pruritus
Timepoint
Before and after each intervention
Method of measurement
Yosipovitch itch assessment questionnaire
Secondary outcomes
1
Description
Self-care needs
Timepoint
Before intervention
Method of measurement
educational need assessment questionnaire based on Orem self-care model.
Intervention groups
1
Description
The control group no received intervention Only in the end, to ethics, to control self-care program was taught during the session Group. And a booklet to provide them and they answered the questions
Category
Other
2
Description
Researcher intervention was performed in 4 sessions of 30 minutes (at least 2 times a week) initially for three face to face sessions, and then a group meeting based on the common need for patients to solve problems and expressing experiences of each as lecture, questions and answers, pamphlets and booklets up to a month in the intervention group.At the end of each session, the time of next training session was determined due to the patient condition (patient consent and taking into account the physical condition) and educational pamphlets regarding the same session were distributed among samples and the complete booklet was given to the patients at the end of intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital in Nourabad Mamasani, ward Hemodialysis
Full name of responsible person
Street address
City
Nourabad Mamasani
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahrokh dolatian
Street address
Tehran - Vali Asr intersection and highway Niayesh - The Rajai cardiac Hospital School of Nursing and Midwifery - Third Floor Research Department
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayebeh khosravi pour
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Tehran - Vali Asr intersection and highway Niayesh - The Rajai cardiac Hospital School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+93 95368392
Fax
Email
tayebeh khosravi4@ gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ms. ِDoctor roghayeh esmaieli
Position
PhD in Nursing
Other areas of specialty/work
Street address
Tehran - Vali Asr intersection and highway Niayesh - The Rajai cardiac Hospital School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+218 8655369
Fax
Email
r_esmaieli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayebeh khosravi pour
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Tehran - Vali Asr intersection and highway Niayesh - The Rajai cardiac Hospital School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+93 95368392
Fax
Email
Tayebeh khosravi4@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)