The effect of performance and non-performance Peplau,s interpersonal relationship theory on stress , depression and anxiety in hemodialysis patients in two groups
This study is implemented with the aim of determining the effects of Peplau’s theory of interpersonal relationship on stress and anxiety and depression in patients undergoing hemodialysis. The study participants are 66 hemodialysis patients aged 30 to 60 years, who are able to communicate. Patients stopping dialysis treatment will be excluded from the study. First, a stress, anxiety and depression questionnaire will be filled out by the patient. Then the patients will be divided into two groups and Peplau’s nursing pattern will be applied to the intervention group. The questionnaire will be completed by the patients again after the intervention. The evaluation will be based on a comparison of questionnaire results before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051217059N8
Registration date:2016-07-10, 1395/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-10, 1395/04/20
Registrant information
Name
Masoume Hemmati Maslakpak
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1365 9031
Email address
hemmati_m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of performance and non-performance Peplau,s interpersonal relationship theory on stress , depression and anxiety in hemodialysis patients in two groups
Public title
The impact of relationship therapy on stress and anxiety and depression in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30 to 60 years; Lack of chronic mental and physical illness and also cognitive, hearing and vision disorders based on the patient record; Being fluent in Turkish or Persian language; Non-member of Medicine Department; written consent by participants to participate in the study. Exclusion criteria: Death during the study period; Kidney or Renal transplantation during the study period; Catching other diseases and exiting from the dialysis program; Dissatisfaction with continuing to participate in the study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use of a sealed bag containing the names of patients and chance choose intervention group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia
City
urmia
Postal code
5714783734
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
ir.umsu.rec.1394.340
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Dialysis (renal) NOS
2
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depression NOS Depressive disorder NOS
3
Description of health condition studied
Stress
ICD-10 code
Z63.7
ICD-10 code description
Anxiety (normal) about sick person in family Health problems within family Ill or disturbed family member Isolated family
4
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
A disorder characterized by the essential descriptive features of a generalized anxiety disorder (F41.1), a panic disorder (F41.0), or a combination of both, but arising as a consequence of an organic disorder
Primary outcomes
1
Description
Stress
Timepoint
before and after intervention
Method of measurement
DASS-21 Stress and Anxiety and Depression Scale
2
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
DASS-21 Stress and Anxiety and Depression Scale
3
Description
Depression
Timepoint
before and after intervention
Method of measurement
DASS-21 Stress and Anxiety and Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Implementation of peplau interpersonal relationship during 7 to 8 sessions with each patient on three stages , including 1- orientation 2- work phase including identify and exploit and 3- finishing stage
Category
Behavior
2
Description
The impact of non-performance Peplau interpersonal relationship on control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Iraj Mohebi
Street address
Shahr chayi, Kashani street
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebi
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmia 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Masoume Hemmati Maslakpak
Position
PhD in Nursing, Associate Professor, Educational Assistant School of Nursing and Midwifery
Other areas of specialty/work
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
Email
hemmatma@yahoo.com
Web page address
http://faculty.umsu.ac.ir/hemmati_m
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Babak Alishahi
Position
Master student Medical Surgical Nursing
Other areas of specialty/work
Street address
Nazlo Pardis Building School of Nursing and Midwifery, 11 km of Sero Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3223 4897
Fax
Email
alishahibabak@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)