The Effect of Virtual Reality on Vital Signs, Oxygen Saturation of Arterial Blood and Pain of Patients During Outpatient Repair of the Skin Rupture in the Emergency Department of Shahid Beheshti Hospital in Qom
The effect of using virtual reality on vital signs and patients' pain perception during outpatient repair of skin rupture in the emergency department.
Design
In this clinical trial study, 80 patients will be selected by available sampling method and randomly assigned to the intervention (40 patients) and control (40 patients) groups using randomized block method. Data collection tools include a pain questionnaire and a vital signs checklist.
Settings and conduct
This study will be performed in the emergency department of Shahid Beheshti Hospital in Qom. No blinding will be performed in this study.In the control group, only lidocaine will be used to reduce patients' pain during repair of the skin rupture. In the intervention group, in addition to the usual care virtual reality glasses will be used and a video containing natural landscapes along with the sounds of nature will be played to the patients. Patients' vital signs and pain will be measured immediately before and immediately after the intervention.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: age over 18 years; having rupture on the upper or lower limbs. Major exclusion criteria: the patient refuses to continue participating in the study; patients who need blood transfusions; patients who need tendon or artery repair; concomitant use of other anesthetic methods in addition to lidocaine.
Intervention groups
In the control group, only lidocaine will be used to reduce patients' pain during repair of the skin rupture. In the intervention group, in addition to the usual care, virtual reality glasses will be used and a video containing natural landscapes along with the sounds of nature will be played to the patients.
Main outcome variables
Stabilization of vital signs and reduction of patients' pain perception during outpatient repair of skin rupture.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150724023314N3
Registration date:2021-03-28, 1400/01/08
Registration timing:prospective
Last update:2021-03-28, 1400/01/08
Update count:0
Registration date
2021-03-28, 1400/01/08
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3242 4753
Email address
mabasiniya@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-30, 1400/01/10
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Virtual Reality on Vital Signs, Oxygen Saturation of Arterial Blood and Pain of Patients During Outpatient Repair of the Skin Rupture in the Emergency Department of Shahid Beheshti Hospital in Qom
Public title
The Effect of Virtual Reality on Vital Signs, Oxygen Saturation of Arterial Blood and Pain of Patients During Outpatient Repair of the Skin Rupture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having rupture on the upper or lower limbs
No history of hearing or vision disorders
Exclusion criteria:
The patient refuses to continue participating in the study
Patients who need blood transfusions
Patients who need tendon or artery repair
Concomitant use of other anesthetic methods in addition to lidocaine
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (200 samples including sample loss), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group.
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 Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2020-11-04, 1399/08/14
Ethics committee reference number
IR.MUQ.REC.1399.197
Health conditions studied
1
Description of health condition studied
Skin rupture
ICD-10 code
T81.33
ICD-10 code description
Disruption of traumatic injury wound repair
Primary outcomes
1
Description
Pain
Timepoint
Immediately before and immediately after repair of the skin rupture
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Immediately before and immediately after repair of the skin rupture
Method of measurement
Vital Sign Monitoring Device
2
Description
Heart rate
Timepoint
Immediately before and immediately after repair of the skin rupture
Method of measurement
Vital Sign Monitoring Device
3
Description
Respiratory rate
Timepoint
Immediately before and immediately after repair of the skin rupture
Method of measurement
Vital Sign Monitoring Device
4
Description
Arterial blood oxygen saturation
Timepoint
Immediately before and immediately after repair of the skin rupture
Method of measurement
Vital Sign Monitoring Device
Intervention groups
1
Description
In the intervention group, during the repair of skin rupture, in addition to injecting 3-5 cc of 2% lidocaine ampoule subcutaneously, a film containing natural landscapes will be played to patients for 20 minutes. VRBOX branded virtual reality headsets will be used for video playback. The intervention will be done only once and during the repair of the skin rupture.
Category
Other
2
Description
In the control group, 3-5 cc of 2% lidocaine ampoule will be injected subcutaneously immediately before repairing the skin rupture to control the patient's pain.