The purpose of this study is to examine the effect of nursing intervention based on "Roy" adaptation model on adaptation of self-concept, role function and interdependence in pemphigus vulgaris patients.Inclusion criteria include: The age between 30 and 50 years; a definitive diagnosis of the disease; willingness to participate in study; at least 6 months passed diagnosis and being Under treatment with oral steroids. Exclusion criteria include: Not attending in training sessions regularly; no follow-up; the patient's own request; change of residence area. In this clinical trail,50 patient will be selected and Will be placed randomly in both intervention and control groups. At First, maladaptive behaviors will be determined by interview. Trainingl content based on maladaptive behaviors in 8 sessions of 60 minutes during 8 weeks with method of lecture will be provided. Monitoring will be done for 1 month after intervention. Then, rate of adaptation in two groups will be measured. The main variable is implementation of nursing intervention based on "Roy" adaptation model that its effect will be evaluated on three dimensions of self-concept, role function and interdependence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041921855N1
Registration date:2015-08-24, 1394/06/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-24, 1394/06/02
Registrant information
Name
Tahereh Ashtab
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0587
Email address
ashtab.t@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research of Gonabad University of Medical Sciencess.
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing intervention based on "Roy" adaptation model on adaptation modes in patients with pemphigus vulgaris
Public title
The effect of nursing care on adaptation in patients with pemphigus vulgaris
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age between 30 and 50 years; A definitive diagnosis of the disease; Willingness to participate in study; At least 6 months passed diagnosis ; Being Under treatment with oral steroids.
Exclusion criteria: Not attending in training sessions regularly; No follow-up or the patient's own request; Change of residence area.
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
education and follow- up of patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to Asian Road- Gonabad
City
Gonabad
Postal code
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
gmu.rec.1393.135
Health conditions studied
1
Description of health condition studied
Pemphigus vulgaris
ICD-10 code
L10.0
ICD-10 code description
pemphigus neonatorum (L00)
Primary outcomes
1
Description
Self concept mode
Timepoint
Before and after intervention
Method of measurement
Questioner and interview
2
Description
Role function mode
Timepoint
Before and after intervention
Method of measurement
Questioner and interview
3
Description
Interdependence mode
Timepoint
Before and after intervention
Method of measurement
Questioner and interview
Secondary outcomes
1
Description
Adaptation strategies
Timepoint
Before and after intervention
Method of measurement
Questioner
Intervention groups
1
Description
In intervention group, after determining maladaptive behaviors and codificationeducational plan, training content in 8 session of 60 minutes and during 8 weeks with method of lecture will be provided.
Category
Other
2
Description
Control group will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi haspital of Tehran University of Medical Sciences