Determining the level of anxiety of patients undergoing hysterectomy before showing the educational video in the intervention group
Determining the level of patients' anxiety after showing an educational video in the intervention group
Comparison of anxiety in patients undergoing hysterectomy before and after showing the educational video in the intervention group
Determining the level of anxiety of patients in the control group for the first time
Determining the level of anxiety of patients in the control group for the second time
Comparison of anxiety in patients undergoing hysterectomy in the control group of the first and second rounds
Comparison of anxiety in the intervention group before showing the film and the first time in the control group
Comparison of anxiety in patients undergoing hysterectomy in the intervention group after showing the film and the second shift in the control group
Design
A controlled clinical trial with randomized parallel groups on 70 patients
Settings and conduct
Intervention and control groups A total of 70 samples were selected that patients underwent hysterectomy referred to Mehr Hospital in Tehran
Participants/Inclusion and exclusion criteria
Have an abdominal or vaginal hysterectomy
Have a favorable general condition
Be hospitalized one day before surgery
Do not have a mental illness
Do not take psychotherapeutic drugs
Do not experience acute anxiety during the last six months
Willing to participate in the study
Complete a written permit
The score of overt and covert anxiety of hysterectomy patients according to the questionnaire is more than 32
Intervention groups
The intervention group was shown an educational video for 15 minutes. The patients in the control group were given the usual hospital training
Main outcome variables
Showing educational video programs for patients undergoing hysterectomy before surgery has an effect on their anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201123049470N1
Registration date:2020-12-08, 1399/09/18
Registration timing:retrospective
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Nargess Zarrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7729 0868
Email address
shahrzaadz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-24, 1398/03/03
Actual recruitment start date
2019-03-16, 1397/12/25
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2019-06-20, 1398/03/30
Scientific title
The effect of care education using video programs on anxiety of patients undergoing hysterectomy
Public title
The effect of educational video on hysterectomy anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have an abdominal (abdominal) or vaginal hysterectomy
Be hospitalized at least one day before surgery
Do not take psychotherapeutic drugs
Have a favorable general condition
Do not experience acute anxiety during the last six months
Willing to participate in the study
Complete a written permit
Do not have a mental illness
The score of overt and covert anxiety of hysterectomy patients according to the questionnaire is more than 32
Exclusion criteria:
Reluctance of the selected patient to cooperate after sampling during the study
Lack of assistance in the general condition of the patient according to the decision of the treating physician
Age
No age limit
Gender
Female
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)
Randomized
Randomization description
Using the random sampling method, the required samples were selected from the patients who referred for hysterectomy and by creating a random sequence using the Simple Randomization method, each item was assigned to one of the intervention and control groups. The same cards recorded the file number of the samples and on other similar cards the words "Individual weeks intervention group" (35 cards) and "Control group, even weeks" (35 cards) were recorded and after placing each category inside the box It was placed separately. Then another person who had no role in the study and was not aware of the sampling method was asked to take a sheet from the second box for each sheet with the file number, which indicated the assignment of that file to one of the intervention and control groups. The selected sheets were placed in an opaque envelope until the test was performed and sealed. This was continued until all the file number sheets were assigned to one of the intervention and control groups.
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 Islamic Azad University of Medical Sciences, Tehran
Street address
No. 13 ,128 e shargh Str. 113 Str. ,Bahar Str. Tehranpars
City
Tehran
Province
Tehran
Postal code
1651715454
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.IAU.TMU.REC.1397.330
Health conditions studied
1
Description of health condition studied
Patients undergoing abdominal and vaginal hysterectomy
ICD-10 code
O82.2
ICD-10 code description
Delivery by caesarean hysterectomy
2
Description of health condition studied
Patients undergoing abdominal and vaginal hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)
Primary outcomes
1
Description
The overt and covert anxiety score of the Spielberger questionnaire
Timepoint
Before and 6 hours after showing educational video programs in the intervention group and before and 6 hours after routine training in the control group
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training videos were shown for 15 minutes, which included a general definition of hysterectomy, familiarity with the operating room space, hysterectomy procedures, answering frequently asked questions, supportive care training before and after hysterectomy, and breathing exercises to reduce Anxiety and movement in bed after surgery were presented to patients
Category
Other
2
Description
Control group: Ordinary and routine hospital training was provided
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Narges Zarrabi
Street address
Mehr Hospital, West Zartosht Ave.
City
Tehran
Province
Tehran
Postal code
1415755415
Phone
+98 21 8245 2414
Email
shahrzadzarrabi@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruhollah Dehghani Firoozabadi
Street address
Khaghani Str. ,Shariati Str., Islamic Azad University
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
shahrzadzarrabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Zarrabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13, 128 e Sharghi Str.,113 Str.,Bahar Str, Tehranpars
City
Tehran
Province
Tehran
Postal code
1651715454
Phone
+98 21 7729 0868
Email
shahrzadzarrabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Zarrabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13 ,128 e Shargh Str.,113 Str., Bahar Str., Tehranpars
City
Tehran
Province
Tehran
Postal code
1651715454
Phone
+98 21 7729 0868
Email
shahrzadzarrabi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nargess Zarrabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 13. 128 e shargh Str. 113 Str. Bahar Str. Tehranpars
City
Tehran
Province
Tehran
Postal code
1651715454
Phone
+98 21 7729 0868
Fax
Email
shahrzaadz@yahoo.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
Part of the data can be shared
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For use in similar research
From where data/document is obtainable
shahrzaadz@yahoo.com Telephone Number 00989121400810
What processes are involved for a request to access data/document
Give an email and, if necessary, call the number and provide documentation about the ongoing study