Protocol summary

Summary
The effect of the health promotion strategies education on self care self efficacy in patients undergoing kidney transplantation. Background: the patients suffering from end stage renal failure, who are waiting for kidney transplantation, are involved in reduction of self care self efficiency because of confronting with new conditions and treatment problems and affects. Objective: the current study was conducted to investigate the effect of health promotion strategies education on self care self efficacy in patients undergoing kidney transplantation. Materials and Methods: this is a randomized clinical trial study which was done in three stages before transplantation and two stages after transplantation on the patients undergoing kidney transplantation in Baghiatallah Hospital in 2012. Sixty patients were randomized to the experimental and control groups; experimental group was trained health promotion strategies. Then, the patients in two groups filled up the questionnaire one and two months after transplantation. The data were analyzed by the soft ware of SPSS version 15 and descriptive and analytic statistics.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013063013816N1
Registration date: 2013-07-23, 1392/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-23, 1392/05/01
Registrant information
Name
Fatemeh Soltannezhad
Name of organization / entity
AJA university
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 0201
Email address
f.soltannejad@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the health promotion strategies education on self care self efficacy in patients undergoing kidney transplantation
Public title
The effect of the health promotion strategies education on self care self efficacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 years or older; Iranian; able to understand, speak and write Persian, and in adequate visional, auditional, conversational and psychological ability to participate in the study. Exclusion criteria: the patient’s death; rejection of transplantation; the recipients dispense with doing transplantation; intensive surgery affects.
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: 60
Randomization (investigator's opinion)
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
AJA University of Medical Sciences
Street address
Beside Imam Reza hospital
City
Tehran
Postal code
16139-18151
Approval date
2012-09-19, 1391/06/29
Ethics committee reference number
9201

Health conditions studied

1

Description of health condition studied
patients under kidny transplantation
ICD-10 code
N19
ICD-10 code description
Unspecified renal failure

Primary outcomes

1

Description
Self care self efficacy
Timepoint
Before intervention, 1 month and 2 months after intervention
Method of measurement
Standard questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: health promotion strategies education within four sessions, each 30 minutes about reduction of stress, coping, nutrition, exercise, drug consuming and self caring after surgery and prevalent complications of kidney recipients, individually and face to face educational booklet. An educational pamphlet delivered to family members; the researcher's telephone number was given to experimental group for probable questions by researcher.
Category
Prevention

2

Description
Control group: The control group was trained according routine training one session30 minute about drugs and nutrition by the nurses of transplantation unit.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AJA University of Medical
Full name of responsible person
Mis Nakhaei
Street address
Beside Imam Reza hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA University of Medical
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
AJA University of Medical Sciences
Full name of responsible person
Fatemeh Soltannezhad
Position
M.Sc
Other areas of specialty/work
Street address
AJA, Nursing College, Shariaty street
City
Tehran
Postal code
Phone
+98 21 7750 0201
Fax
Email
f.soltannejad@ajaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fatemeh Soltannezhad
Position
M.Sc.
Other areas of specialty/work
Street address
AJA, Nursing College, Shariaty street
City
Tehran
Postal code
Phone
+98 21 7750 0201
Fax
Email
flsoltannezhad@ajaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fatemeh Soltannezhad
Position
Msc
Other areas of specialty/work
Street address
Tehran-AJA Nursing Calege
City
Tehran
Postal code
16139-18151
Phone
+98 21 7750 0201
Fax
+98 21 7760 1533
Email
f.soltannejad@ajaums.ac.ir; f.soltannezhad@gmail.com
Web page address
www.ajaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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