Determine the effect of showing surgery educational documentary film on the anxiety of patients candidate for lumbar disc surgery
Design
Clinical trial with control group, non-randomized assignment to intervention and control groups, with parallel group, without blindness
Settings and conduct
The researcher will not be able to exchange information between a hospital in the control group and the hospital in the intervention group because of the patient's lack of interaction. And the researcher on consecutive days, referring to the special clinic of Al-Zahra and Ayatollah Kashani hospitals and in coordination with the honoring of these hospitals, the list of patients with a lumbar spine and included in their list of activities and have entry requirements They will identify and coordinate with them.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Have the ability to communicate voice and audio the desire to participate in the study Ability to read and write Not attending other training programs during the study No cognitive impairment, no known mental illness Previously, surgical procedures for vertebral discs have not been performed age18-64 years Exclusion criteria:Opt out of the study for any reason is Use of sedative or anxiolytic drugs during the study Coincident in another study
Intervention groups
Intervention group: First, measure the mean anxiety score before the intervention, then show a documentary film for lumbar disc surgery and then measure anxiety with the Spielberger questionnaire one day after the intervention Control group: Measurement of anxiety score before intervention and then measuring anxiety with the Spielberger questionnaire the next day without any intervention other than routine training
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180531039926N1
Registration date:2018-07-26, 1397/05/04
Registration timing:retrospective
Last update:2018-07-26, 1397/05/04
Update count:0
Registration date
2018-07-26, 1397/05/04
Registrant information
Name
Mohammad reza Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 5665
Email address
mr.abdi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
empty
Scientific title
Investigating the effect of showing surgery educational documentary film on the anxiety of patients candidate for lumbar disc surgery
Public title
the effect of showing surgery educational documentary film on the anxiety of patients candidate for lumbar disc surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have the ability to communicate voice and audio
the desire to participate in the study
Ability to read and write
Not attending other training programs during the study
No cognitive impairment, no known mental illness
Previously, surgical procedures for vertebral discs have not been performed
age18-64 years
Exclusion criteria:
Opt out of the study for any reason is
Use of sedative or anxiolytic drugs during the study
Coincident in another study
Age
From 18 years old to 64 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Isfaha University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.MUI.REC.1396.3.840
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
state anxiety
Timepoint
Before and one day after the intervention
Method of measurement
Spielberger state anxiety inventory
2
Description
trait anxiety
Timepoint
Before and one day after the intervention
Method of measurement
Spielberger trait anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, measure the mean anxiety score before the intervention, then show a documentary film for lumbar disc surgery for 20 minutes and then measure anxiety with the Spielberger questionnaire one day after the intervention
Category
Other
2
Description
Control group: Measurement of anxiety score before intervention and then measuring anxiety with the Spielberger questionnaire the next day without any intervention other than routine training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
St-zahra educational hospital
Full name of responsible person
Mohammad reza Abdi
Street address
isfahan University of Medical Sciences, Hezar jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mr.abdi30@gmail.com
2
Recruitment center
Name of recruitment center
Kashani educational hospital
Full name of responsible person
Mohammad reza Abdi
Street address
Kashai street, Kashani hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3233 0091
Email
mr.abdi30@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
خ هزار جریب، دانشگاه علوم پزشکی اصفهان، دانشکده پرستاری و مامایی
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7580
Email
zahra_ghazavi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad reza Abdi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 30, Shahid Ebrahimi Coy, Mosque of Seyed Street
City
Esfahan
Province
Isfehan
Postal code
8136953861
Phone
+98 31 3236 5665
Email
mr.abdi30@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Ghazavi
Position
Academic Member/ Master of Science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Psychiatric Nursing Dept. Nursing and Midwifery Faculty Isfahan University Of Medical Sciences Hezar Jereb Avenue
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7580
Email
zahra_ghazavi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad reza Abdi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 30, Shahid Ebrahimi Coy, Mosque of Seyed Street
City
Esfahan
Province
Isfehan
Postal code
8136953861
Phone
+98 31 3236 5665
Email
mr.abdi30@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Tez
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
In order to influence the care and treatment
From where data/document is obtainable
email:mr.abdi30@gmail.com mohammad reza abdi
What processes are involved for a request to access data/document