study Design: three group, randomized Clinical trial.Research Environment: Ibn Sina Psychiatric Hospital, Mashhad. Patients with mood disorders have been studied are using a table of random numbers randomly into three groups consisting of two intervention groups and one control group.
Inclusion criteria: Mood disorders diagnosed by a psychiatrist; Have the ability to communicate voice and audio; lack of psychotic disorder at the time of the Electroconvulsive Therapy (ECT). Exclusion criteria: patients who have received fewer than four sessions of ECT; patients with complications of ECT. The study population of patients with mood disorders. Sample size: 75 Intervention: Intervention face to face training and multimedia time: two and a half months of study. outcomes: Anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031527067N1
Registration date:2016-06-21, 1395/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Mohsen Sepehrikia
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 302 4484
Email address
sepehrikiam2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Department Of Research
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of face to face education with multimedia education on anxiety due to Electroconvulsive Therapy in patients with mood disorders
Public title
The effect of face to face with multimedia training on anxiety caused by Electroconvulsive Therapy (ECT)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of mood disorders is given by a psychiatrist; live in the city or suburbs of Mashhad is willing to participate in the study; Have the ability to communicate voice and audio; lack of physical illness leads to cognitive impairment; lack of psychotic disorder at the time of the Electroconvulsive Therapy. Exclusion criteria: Opt out of the study for any reason is; patients who have received fewer than four sessions of Electroconvulsive Therapy; patients with complications of Electroconvulsive Therapy.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
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 Mashhad University of Medical Sciences
Street address
Crossing Doctora, Street Ibn Sina University School of Nursing and Midwifery
City
Mashhad
Postal code
9137913199
Approval date
2016-03-10, 1394/12/20
Ethics committee reference number
IR.MUMS.REC.1394.711
Health conditions studied
1
Description of health condition studied
Mood disorders
ICD-10 code
F31, F32
ICD-10 code description
Bipolar affective disorder, Depressive episode
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention; after intervention before Electroconvulsive Therapy; before the midsession and before the start of the final session of Electroconvulsive Therapy
Method of measurement
Spielberger anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group face to face training for Thirty minutes
Category
Other
2
Description
In the second group intervention multimedia training for Thirty minutes
Category
Other
3
Description
Usual care control group, such as fasting, voiding, and will be carried out jewelry and metals
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina psychiatric hospital
Full name of responsible person
Saeed Vaghee
Street address
Hurr Ameli end of the street, next to the of transport Astan Quds
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Department Of Science and Technology, Mashhad University Of Medical Sciences, Next to the Hoveyze Cinema, University Avenue
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Position
Mashhad University of Medical Sciences, Department Of Research
Other areas of specialty/work
Street address
Department Of Science and Technology, Mashhad University Of Medical Sciences, Next to the Hoveyze Cinema, University Avenue
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
sepehrikiam2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Sepehrikia
Position
Master of nursing
Other areas of specialty/work
Street address
No. 140, Street Naserkhosro 20
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Sepehrikiam2@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Sepehrikia
Position
Master of nursing
Other areas of specialty/work
Street address
No. 140, Street Naserkhosro 20
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)