The aim of this study is to evaluate the effect of using virtual reality glasses on stress and pain during intra-corporeal lithotripsy under spinal anesthesia.
Design
in this RCT with a control group, without blinding, 90 patients are randomized to two groups.
Settings and conduct
The patients who were candidates for Transurethral lithotripsy because of nephrolithiasis in urether in urology ward, Imam Khomeini Hospital were randomized to two groups by block randomization method. patients in intervention group used a Virtual reality headset from 10 min before surgery till the end. Control group received no intervention. Stress level of patients was recorded before and after surgery by STAI questioner. also pain level (with VAS) before and after surgery, and Vital signs including Blood pressure, Heart rate, and the amount of sedatives were recorded by a single nurse practitioner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 65 years undergoing Trans Ureteral Lithotripsy surgery due to ureteral stones. Exclusion criteria: Patients requiring complete anesthesia; patients requiring emergency surgery; significant impairments of the senses of vision and hearing; history of epilepsy.
Intervention groups
Patients in the intervention group use virtual reality glasses from 10 minutes before surgery until the end of the procedure. There is no intervention in the control group during surgery.
Main outcome variables
Pain level, stress level, Vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180331039164N1
Registration date:2019-02-05, 1397/11/16
Registration timing:registered_while_recruiting
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Amir Mohammad Papan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3441 1798
Email address
papan.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality glasses on intra-operative stress and pain during intra-corporeal lithotripsy under spinal anesthesia
Public title
Effect of virtual reality glasses on intra-operative pain during lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
From 18 years old to 65 years old
Candidate for Trans Ureteral Lithotripsy for ureteral stone
Exclusion criteria:
Patients who need complete anesthesia.
Patients in need of emergency surgery
Significant impairments of the senses of vision and hearing
History of epilepsy
People who suffer from headache, nausea and vomiting due to using the glasses.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of test and control will be done by Block Balanced Randomization (BBR) method. The Randomization Sequence will be generated with using the free website at http://www.randomization.com.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.AJUMS.REC.1396.1064
Health conditions studied
1
Description of health condition studied
Calculus of ureter
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
The stress level of patients according to State-trait Anxiety Inventory
Timepoint
At the beginning of study (before the surgery) and after the end of surgery
Method of measurement
State-trait Anxiety Inventory
2
Description
pain acording to VAS scale
Timepoint
At the beginning of study (before the surgery) and after the end of surgery
Method of measurement
asking the patient acording to VAS scoring system
3
Description
patient's Blood Pressure before, every 10 minutes and after surgery
Timepoint
At the beginning of study (before the surgery) and after the end of surgery
Method of measurement
holter monitoring
4
Description
patient's pulse rate before, every 10 minutes and after surgery
Timepoint
continues before, during and after surgery
Method of measurement
continues ECG monitoring
Secondary outcomes
1
Description
Side effects
Timepoint
Every 20 minutes during the surgery and at the end of surgery
Method of measurement
Clinical observations
Intervention groups
1
Description
Intervention group: Patients in the intervention group use virtual reality glasses (Quilo brand) from the 10 minutes before surgery until the end of the procedure.
Category
Treatment - Devices
2
Description
Control group: There is no intervention in the control group during surgery.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Street address
Imam Khomeini Hospital, Azadegan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 4355 4063
Email
khazaeli-d@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3292 1837
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Department of Urology, Imam Khomeini Hospital, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2114
Email
khazaeli-d@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Mohammad Papan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences., Golestan Highway., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3441 1798
Fax
Email
amirmohammadpapan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pedram Nazari
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 4355 4063
Email
nazari.p@ajums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available