Objective: Determining the effects of supportive_ educational nursing interventions on cognitive status of patients treated with ECT at Razi Academic Hospital in Urmia.
Inclusion criteria: Patients with 18-60 years old, with no major cognitive and sensory impairments.
Exclusion criteria: Patients who receive more than one attempt of electrical shock treatment in one day in order to induce effective convulsive response.
Target population: Hospitalized psychiatric patients who have been assigned to ECT treatment by their psychiatrists.
Sample size: 102 Patients will be randomly assigned into intervention and control groups (n = 51 in each group).
Intervention: The intervention of this study consists of two parts: Patient education and supportive cares. During this period the control group, will receive education routine and usual care made by nurses. The timing of these interventions will begin at recommendation of ECT treatment for patients and will continue and will continue after the 6th session of ECT. Instruments for data gathering and measuring will be demographic information questionnaire and Mini Mental Status Examination.
Primary outcome measure: Cognitive Status of patient's in the both control& intervention groups. Within 15, 30, 60 min and 24 hrs after the first, third and sixth ECT sessions will be evaluated.
General information
Acronym
Electroconvulsive Therapy (ECT)
IRCT registration information
IRCT registration number:IRCT2015052916564N4
Registration date:2015-07-21, 1394/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
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
Study The effect of supportive_ educational nursing interventions on cognitive status of patients treated with Electroconvulsive Therapy (ECT)
Public title
Cognitive status of patients treated with Electroconvulsive Therapy (ECT)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-60 year; lack of physical disease leads to cognitive impairment; lack of chronic disease and disability; and negative symptoms of schizophrenia, associated with their impaired reality-testing ability.
Exclusion criteria: Patients who are receiving less than 6 sessions of ECT; patients who receive more than one attempt of electrical shock treatment in one day in order to induce effective convulsive response.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urjance alley, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
ir.umsu.rec.1393.282
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
2
Description of health condition studied
Major depression
ICD-10 code
F32.3
ICD-10 code description
Severe depressive episode with psychotic symptoms
3
Description of health condition studied
Bipolar mood disorder
ICD-10 code
F31.9
ICD-10 code description
Bipolar affective disorder, unspecified
Primary outcomes
1
Description
Cognative status
Timepoint
Within the period of 15, 30, 60 minutes and 24 hours after the first, third and sixth Electroconvulsive Therapy
Method of measurement
Mini Mental Status Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention consists of two parts: First part of the intervention consists of patient-education by the researcher who has experience as psychiatric nurse. This part will done after determining the educational needs of the patient and according to previous information and the level of education. Educative intervention will be 30 minutes sessions which will be face-to-face and individually performed in the psychiatric-exam room located within the psychiatric wards. Material presented in this program; include a brief description on the electro convulsive therapy, introduction to its application, the beneficial effects of treatment, methods and preparations, complications, drugs and nursing care before and after ECT. The second part of intervention will be supportive in nature. It will begin just before the each ECT session and will continue after 2 hours of ECT administration. These interventions include effective communication with the patient and supportive care in three dimensions: Information, emotional and physical, including providing information to patients, Responding to questions asked by patients before, During and after the sessions, Explaining the reasons for using this method in patients, explaining the responsibilities of treatment group members, encouraging to express feelings, assessing negative beliefs and fears of patients. Stablishing mutual trust, as well as physical care of these patients due to patient safety in terms of damage due to cognitive impairment after ECT,encouraging patient to do physical activity in order to reduce physical pain between sessions.
Category
Other
2
Description
Control group: Control group will receive education routine and usual care by nurses including: NPO, Voiding , Leaving jewelry and metals
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Academic Hospital
Full name of responsible person
Dr. Rahim Khalilzadeh
Street address
km 3 road salmas, Razi Academic Hospital, urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences, Vice chancellor for reasearch
Full name of responsible person
Dr. iraj Mohebby
Street address
Urjance alley, 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
Urmia University of Medical Sciences, Vice chancellor for reasearch
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
Urmia University of Medical Sciences, Nursing and Midwifery Faculty
Full name of responsible person
Sarieh Sheikhmohammadi
Position
The master science student of nursing
Other areas of specialty/work
Street address
11 Km Road seru, Campus Nazlu, University of Medical Sciences, Nursing and Midwifery Faculty
City
Urmia
Postal code
575611-5111
Phone
+98 44 3275 4961
Fax
Email
www.sheikhmohammadi_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences, Nursing and Midwifery Faculty
Full name of responsible person
Dr. Moloud Radfar
Position
Ph.D of Nursing
Other areas of specialty/work
Street address
11 Km Road seru, Campus Nazlu, University of Medical Sciences, Nursing and Midwifery Faculty
City
Urmia
Postal code
575611-5111
Phone
+98 44 3275 4961
Fax
Email
mradfar1343@gmail.com; radfar.m@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia Medical Science University
Full name of responsible person
Sarieh Sheikhmohammadi
Position
The master science student of nursing
Other areas of specialty/work
Street address
11 Km Road seru, Campus Nazlu, University of Medical Sciences, Nursing and Midwifery Faculty
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4964
Fax
Email
www.sheikhmohammadi_s@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)