Evaluation of the effect of training using virtual reality on reducing anxiety before performing invasive surgical procedures in patients with maintenance hemodialysis
• Determining the level of anxiety in patients undergoing maintenance hemodialysis before surgical procedures in the control and intervention groups before and after the intervention
• Comparison of anxiety of patients treated with maintenance hemodialysis before surgical procedures in each of the control and intervention groups before and after the intervention
Design
Clinical trial with control group, parallel groups, non-random allocation, phase 2 on 20 patients.
Settings and conduct
The sampling place is Imam Khomeini Hospital. The selection of samples is one of the departments in which patients related to renal failure are admitted and then admitted to prepare for surgery.
After receiving the consent of the patients and controlling the inclusion criteria of the patients in the study, they are divided into two groups of intervention and control. Before intervention, Anxiety questionnaire will be given to both groups. The intervention group receives the produced content using virtual glasses. The intervention group will be intervened for one month and two sessions per week. The control group will not receive any intervention. After the intervention for one month, the anxiety questionnaire will be given to both groups again.
Participants/Inclusion and exclusion criteria
informed consent to participate in the study
Fixed final diagnosis
Hemodialysis treatment on a weekly basis
No underlying diseases
Have minimum level of literacy
Intervention groups
In this study, the intervention group receives training using virtual reality. This training includes all the events and issues that the patient is going to face in the operating room, will be displayed step by step from the moment of entering the operating room, during the operation and then after that.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220416054545N1
Registration date:2022-04-26, 1401/02/06
Registration timing:prospective
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
manijeh hooshmandja
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8850 4058
Email address
hoshmand.66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-04, 1401/02/14
Expected recruitment end date
2022-06-04, 1401/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of training using virtual reality on reducing anxiety before performing invasive surgical procedures in patients with maintenance hemodialysis
Public title
Investigating the effect of virtual reality in reducing patients' anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Fixed final diagnosis
Hemodialysis treatment on a weekly basis
No underlying diseases
Have a minimum level of literacy
Exclusion criteria:
Dissatisfaction for participating in the study
Once Absence
Incomplete answer to the questionnaire
Age
From 22 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
School of Medicine - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417634981
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1035
Health conditions studied
1
Description of health condition studied
reducing anxiety Patients with maintenance hemodialysis
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
score Anxiety in BAI - Beck Anxiety Inventory
Timepoint
One month and two sessions per week
Method of measurement
BAI - Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is trained in virtual reality about surgical procedures for two months each week for two sessions and on average 10 to 15 minutes after connecting the dialysis system. In this method, virtual reality glasses are used that are placed on the eyes of patients in the intervention group. At this time, images and videos about the surgical procedures are played and in terms of audio, headphones are used that are placed on both ears in a way that by playing the sound of that environment, the person enters the virtual space.
Category
Behavior
2
Description
Control group: The control group did not receive any intervention