Protocol summary

Summary
Determine the effect of psycho nursing counseling on internalized stigma and self-efficacy in patients receiving electroconvulsive therapy (ECT) hospitalized in Farshchian hospital in Hamadan. Objective: Determine the effect of psycho nursing counseling on internalized stigma and self-efficacy in patients receiving electroconvulsive therapy (ECT) Farshchian hospital in Hamedan Type of study: Quasi-experimental, before and after with control group. Design: The study sample is consisted of 114 patients receiving electroconvulsive. questioner of Demographic information, efficacy and internalized stigma in patients will be compeleted in the free hours and when do not require special procedures with the direct monitoring of researcher. Assigned into two intervention and control groups using random blocks. 4 sessions ,twice a week ,for 60 minutes (45 minute consultation, a 5-minute summary and a 10-minute Q & A) will be held by speeches, questions and answers and training package in one of the consultation rooms in psychiatric units. Inclusion criteria: The patient is a candidate therapeutic ECT. not having history of drug abuse. not being in the acute phase of psychosis. Exclusion criteria: If selected patients unwilling to continue to participate in the study. If the patient is in the acute phase of psychosis. Main outcome measures: self efficacy, internalized stigma, electro convulsion therapy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041133378N1
Registration date: 2017-05-23, 1396/03/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-23, 1396/03/02
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of psycho nursing cunsaltant on internalized stigma and self efficacy of patient receive ECT hospitalized in Farshchian hospital ,Hamedan
Public title
Psycho Nursing consaultant in mental disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion critera: The patient is a candidate of ECT, being older than 18 years, not suffering from physical diseases that lead to cognitive impairment, does not have a physical disability, not having history of drug abuse, not being in the acute phase of psychosis, need to receive ECT is not on an emergency basis, be able to speak Persian. Main Exclusion criteria: If selected patients unwilling to continue to participate in the study, If the patient is in the acute phase of psychosis, Patients who discharge by doctor or personal satisfaction before study will bo compeleted, Patients who have attempted suicide during the study will be excluded.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 114
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
Ethics Committee of University of Medical Science
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan Hamedan
City
Hamedan
Postal code
Approval date
2017-04-13, 1396/01/24
Ethics committee reference number
IR.UMSHA.REC.1396.16

Health conditions studied

1

Description of health condition studied
Mental and Behavioural Disorders
ICD-10 code
F00, F01,
ICD-10 code description
Mental and Behavioural Disorder

Primary outcomes

1

Description
Stigma
Timepoint
Before, two week after start and two week after finish
Method of measurement
Internalized Stigma of Mental Ilness Questionair

2

Description
Self Efficacy
Timepoint
Before, two week after start and two week after finish
Method of measurement
Self Efficacy SHerer Questionair

Secondary outcomes

empty

Intervention groups

1

Description
Four sessions of psycho nursing consultant face to face and individual
Category
Lifestyle

2

Description
Control group just recieve routin cares
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Educational and Medical Center
Full name of responsible person
Parisa Rostami
Street address
Mirzadeh Eshghi street
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Vice-Chancellor Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Research and Technology Vice-Chancellor, Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice-Chancellor Hamedan 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
University of Medical Science
Full name of responsible person
Parisa Rostami
Position
Student of MS/Nurse
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3833 1627
Fax
Email
ghasedak_pr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Science
Full name of responsible person
Efat Sadeghian
Position
PHD of Nursing
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 0319
Fax
Email
sadeghianefat@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Science
Full name of responsible person
Parisa Rostami
Position
Student of MS
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
6516775474
Phone
+98 81 3833 1627
Fax
Email
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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