Determining the effect of video training on fear and anxiety in patients undergoing electroconvulsive therapy admitted to a psychiatric ward
Design
The present study is a randomized two-group clinical trial study that will be performed with the participation of 72 patients. The research units will be selected by available sampling method and will be randomly divided into two groups of control and test.
Settings and conduct
This study is a randomized clinical trial that will be conducted to investigate the effect of video training on fear and anxiety of patients undergoing electroconvulsive therapy admitted to psychiatric ward of Sina hospital in Hamadan on 72 patients. patients will be randomly divided into two groups of control and intervention. The intervention group will be provided with an instructional video on the method of electroconvulsion therapy. Educational intervention for the intervention group will be done in 3 sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Do not have vision or hearing problems, Patients must be fully conscious, Patients who are first-time candidates for electroconvulsive therapy.
Exclusion criteria: Patients in the psychotic phase.
Intervention groups
Intervention group: In the intervention group will be provided with educational materials on the method of electrical convulsion therapy by educational video. The content of the film will include: steps, complications, introduction to the environment, before and after nursing care. The film will be broadcast the day before the electroconvulsive therapy.Control group: There will be no special intervention
Main outcome variables
Fear and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170411033378N9
Registration date:2021-09-11, 1400/06/20
Registration timing:prospective
Last update:2021-09-11, 1400/06/20
Update count:0
Registration date
2021-09-11, 1400/06/20
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
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of video based education on fear and anxiety of patient candidates for Electroconvulsive therapy at psychiatric ward
Public title
The effect of video based education on fear and anxiety of patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are first-time candidates for electroconvulsive therapy.
Patients must be fully conscious.
Do not have vision or hearing problems.
Exclusion criteria:
Patients in the psychotic phase
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available method with considering inclusion criteria, then divided into two intervention and control groups by randomized allocation. Random allocation will be by permuted block randomization. It is individual randomization. First, a random list is generated using R software in which the intervention group (A) and the control group (B) are based on blocks such as ABAB. And AABB, ABBA and ... are randomly generated based on the number of samples. Then these lists are put into an envelope and one of the envelopes is randomly selected by referring patients and then individuals are assigned to group A Or B are allocated. Due to the educational intervention and having the control and experimental group there is no possibility of blinding the participants.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2021-07-30, 1400/05/08
Ethics committee reference number
IR.UMSHA.REC.1400.350
Health conditions studied
1
Description of health condition studied
Mood disorders
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
Fear
Timepoint
Before intervention and before receiving electroconvulsive therapy
Method of measurement
Visual analog scale
2
Description
Anxiety
Timepoint
Before intervention and before receiving electroconvulsive therapy
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the intervention group will be provided with educational materials on the method of electrical convulsion therapy by educational video. The content of the film will include: steps, complications, introduction to the environment, before and after nursing care. The film will be broadcast the day before the electroconvulsive therapy.Control group: There will be no special intervention.
Category
N/A
2
Description
Control group: No special intervention will be taken other than routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Efat Sadeghian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghianefat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghianefat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghianefat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghianefat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available