Protocol summary

Summary
The purpose of current research is to determine the effect of peer support groups on self-transcendence and physical and mental health status in patients on hemodialysis groups.This research with case and control groups was performed on 64 patients under hemodialysis in Sabzevar vasei hospital. 64 patients were selected, 32 patients in each group. Participants attended 8 weekly sessions' comprising 2 hours each while the control group received the routine care of the institute . Research tools were " Self-Transcendence Scale (STS)" and "Kidney Disease Quality of Life Short Form(KDQOL-SFTM)". Before and after the intervention, tools were completed by the patients in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014082018882N1
Registration date: 2015-02-12, 1393/11/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-12, 1393/11/23
Registrant information
Name
Akram Malek Khahi
Name of organization / entity
Sabzevar University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 1991
Email address
malek049@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Scinces
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer support groups on self-transcendence and physical and mental health status in patients on hemodialysis groups
Public title
The effect of peer support groups on self-transcendence and physical and mental health status in patients on hemodialysis groups
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Age over 18 years; At least 6 months of dialysis; Patients with active files in Sabzevar Hemodialysis Center. Exclusion criteria: Absence of more than two sessions.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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
Sabzevar University of Medical Scinces
Street address
School of Nursing and Midwifery; next to the police station to Shahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2013-12-06, 1392/09/15
Ethics committee reference number
medsab.Rec.92.9

Health conditions studied

1

Description of health condition studied
End stage renal failure
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
Physical health status
Timepoint
Before, after intervention
Method of measurement
Kidney Disease Quality of Life Short Form

2

Description
The psychological health
Timepoint
Before, after intervention
Method of measurement
Kidney Disease Quality of Life Short Form

3

Description
Self-Transcendence
Timepoint
Before, after intervention
Method of measurement
Self-Transcendence Scale

Secondary outcomes

empty

Intervention groups

1

Description
The peer support group was formed, 2 hour sessions, for 8 weeks. The session subject was about hemodialysis patients' problems
Category
Behavior

2

Description
The control group just received ward routine cares.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Vasei hospital
Full name of responsible person
Akram Nazarkhahi
Street address
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery; next to the police station to Shahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Scinces
Full name of responsible person
Akram Malek Khahi
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to Shahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4465 1300
Fax
Email
malek049@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University in Tehran
Full name of responsible person
Maryam Jadid Milani
Position
PHD Nursing
Other areas of specialty/work
Street address
Shahed University in Tehran
City
Tehran
Postal code
Phone
+98 57 1444 6070
Fax
Email
milani2000ir.yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Akram Malek Khahi
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to Shahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
malek049@yahoo.com
Web page address

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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