The effect of training using virtual reality (VR) method on the anxiety of patients before cesarean section
Design
This clinical trial study has a control group with one-way blinded parallel groups and is conducted on 70 patients.
Settings and conduct
Study is conducted in Imam Ali Chabahar Hospital. The process of educating patients in this study is implemented in three steps:1. Compilation of the educational scenario and filming with a 360-degree camera2. Playing a 360-degree educational video with virtual reality glasses for the intervention group and routine training for the control group3. Before training and after training, evaluation with a questionnaire
Participants/Inclusion and exclusion criteria
The entry criteria are being in the age range of 18 to 45, having consent, and the exit criteria being emergency cesarean surgery, history of drug use, history of surgery, and cardiovascular and nerve diseases.
Intervention groups
The intervention group includes patients who are candidates for non-emergency cesarean surgery. The researcher explains the objectives of the study and after obtaining their consent to participate in the research, the patient's demographic questionnaire is completed using an interview, and then the intervention group is given the night before the operation in the gynecologist's office, a 360-degree educational video with virtual reality glasses for the patient. will be broadcasted, also for the control group, routine training will be given before the operation.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230409057865N1
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
masoumeh mobaraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 840 5155
Email address
m.mobaraki@irshums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-20, 1402/04/29
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training using virtual reality (VR) method on the anxiety of patients before cesarean section
Public title
The effect of training using virtual reality (VR) method on the anxiety of patients before cesarean section
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being in physical condition (ASA) 1 and 2 graded by American Anesthesiologists
Being in the age range of 18-45 years
Consent to participate in the study
Exclusion criteria:
The emergency of cesarean surgery
History of taking anti-anxiety and sedative drugs
History of cesarean surgery
History of heart, nervous and mental diseases, uncontrolled blood pressure, eclampsia
Women who are members of the hospital staff
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The random selection of the intervention and control groups is simple random.Flip the coin method is used, based on the sample size, the same number of coins are thrown and people are randomly assigned to two groups. This random selection is obtained from the patients admitted to the gynecologist's office.
Blinding (investigator's opinion)
Single blinded
Blinding description
The interviewer does not know the type of intervention and control group to assess the level of anxiety with a questionnaire. and records the answer according to the patient's answer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iranshahr University of Medical Sciences
Street address
Shahid Moradi Blvd, Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9913743137
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.IRSHUMS.REC.1401.028
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
anxiety
Timepoint
24 hours before the intervention - one hour after the intervention
Method of measurement
Amsterdam anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The night before the operation, in the gynecologist's office, training is given on how to use virtual reality glasses, and a 360-degree educational video with virtual reality glasses is played for the patient, the content of a complete virtual reality tour in Persian and local (Baluchi) languages. The preparation time is 10 minutes and its scenario is designed based on the standards of patient education and the patient's legal charter. The Amsterdam questionnaire is completed one hour before the procedure.
Category
Treatment - Devices
2
Description
Control group: for the control group, routine training will be given before cesarean section.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali hospital, Chabahar city
Full name of responsible person
Masoumeh Mobaraki
Street address
Qods Blvd
City
chabahar
Province
Sistan-va-Balouchestan
Postal code
99719 43311
Phone
+98 54 3533 3016
Email
info@irshums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Abbas Balouchi
Street address
No. 46 ,Emam khomeini Ave , Iranshahr city
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9913743137
Phone
+98 54 3721 3389
Email
info@irshums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr University of Medical Sciences
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
Iranshahr University of Medical Sciences
Full name of responsible person
Masoumeh Mobaraki
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
NO. 46, Emam Khomeini Ave
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9913743137
Phone
+98 54 3721 3389
Email
masimobaraki1370@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Masoumeh Mobaraki
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
NO. 46, Emam khomeini Ave
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9913743137
Phone
+98 54 3721 3389
Email
masimobaraki1370@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Masoumeh Mobaraki
Position
Faculty instructor
Latest degree
Specialist
Other areas of specialty/work
Midwifery
Street address
NO. 46, Emam Khomeini Ave
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9913743137
Phone
+98 54 3721 3389
Email
masum547@yahoo.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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available