Determining the effect of using virtual reality and standard care on pain intensity, anxiety and satisfaction of emergency patients during suturing
Design
In this study, 90 people will be randomly divided into two groups, including the group that uses virtual reality and the group receiving standard care
Settings and conduct
90 patients referred to the emergency department of Imam-Reza Hospital in Birjand who are eligible to enter the study will be selected and randomly divided into two groups. For the intervention group, in addition to standard care, relaxing images and music will be played by the virtual reality headset from one minute before the suturing procedure to 10 seconds after the end of the procedure, and the control group will receive only the standard care provided by the hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient satisfaction; age 18 to 60 years old; a wound need to be sutured according to the doctor prescription; the wound is on the trunk or limbs; no fractures or other accompanying injuries; the wound or tear should only include the skin layer; no injury to fascia, muscle and underlying tissues at the site of rupture; the size of the injury should be about 5 to 10 cm, The patient has visual health; the patient has hearing health; the patient should not be addicted to drugs; patients do not suffer from dementia or Alzheimer's; patients do not get motion sickness and stroke; patients do not have seizures and epilepsy; having the ability to speak and communicate. Exclusion criteria: reluctance to cooperate or participate in the study; the site of the wound or laceration is on the head, face or neck; phobias of the forest and other images used in virtual reality.
Intervention groups
Two groups: Virtual reality use group; standard care recipient group.
Main outcome variables
Pain intensity and anxiety; satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200807048331N2
Registration date:2020-12-30, 1399/10/10
Registration timing:prospective
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Ali Sheikhalishahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3722 0539
Email address
ali.sheikhalishahi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using virtual reality and Standard Care on pain intensity, anxiety and satisfaction of emergency patients during suturing
Public title
The Effect of Virtual Reality on Pain, Anxiety and Satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
Age 18 to 60 years old
A wound or laceration needs to be sutured according to the doctor's priscription.
The wound is on the trunk or limbs
No fractures or other accompanying injuries
The wound or tear should only include the skin layer.
No injury to fascia, muscle and underlying tissues at the site of rupture (according to the doctor)
The size of the injury should be about 5 to 10 cm.
The patient has visual health.
The patient has hearing health.
The patient should not be addicted to drugs.
Patients do not suffer from dementia or Alzheimer's
Patients do not get motion sickness and stroke
Patients do not have seizures and epilepsy
Having the ability to speak and communicate
Exclusion criteria:
Reluctance to cooperate or participate in the study
The site of the wound or laceration is on the head, face or neck
Phobias of the forest and other images used in virtual reality
Age
From 18 years old to 60 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
Using the simple random allocation method, a coin is tossed so that the head side is equivalent to the intervention group and the tail side is equivalent to the control group. This launch is for the first person and the type of group will be determined for it. Then for other people, it continues as one among the type of group and based on the sample size, this allocation continues, and thus, the type of group for each person will be determined randomly.
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 Birjand University of Medical Sciences
Street address
Deputy of research and technology, Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-12-21, 1399/10/01
Ethics committee reference number
IR.BUMS.REC.1399.396
Health conditions studied
1
Description of health condition studied
Open wound of ankle, foot and toes
ICD-10 code
S91
ICD-10 code description
Open wound of ankle, foot and toes
2
Description of health condition studied
Open wound of knee and lower leg
ICD-10 code
S81
ICD-10 code description
Open wound of knee and lower leg
3
Description of health condition studied
Open wound of hip and thigh
ICD-10 code
S71
ICD-10 code description
Open wound of hip and thigh
4
Description of health condition studied
Open wound of wrist, hand and fingers
ICD-10 code
S61
ICD-10 code description
Open wound of wrist, hand and fingers
5
Description of health condition studied
Open wound of elbow and forearm
ICD-10 code
S51
ICD-10 code description
Open wound of elbow and forearm
6
Description of health condition studied
Open wound of shoulder and upper arm
ICD-10 code
S41
ICD-10 code description
Open wound of shoulder and upper arm
7
Description of health condition studied
Open wound of abdomen, lower back, pelvis
ICD-10 code
S31
ICD-10 code description
Open wound of abdomen, lower back, pelvis and external genitals
8
Description of health condition studied
Open wound of thorax
ICD-10 code
S21
ICD-10 code description
Open wound of thorax
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before the intervention, during the intervention and after the end of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Anxiety
Timepoint
Before the intervention, during the intervention and after the end of the intervention
Method of measurement
Anxiety Linear Scale
3
Description
Satisfaction
Timepoint
After the end of the intervention
Method of measurement
Satisfaction linear scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to routine care, a virtual reality headset will be used from one minute before the start of the procedure to 10 seconds after the end of the procedure. In this way, the headset will fit the patient on the head, so that the eyes are covered with camera lenses and the ears with audio players. The researcher will explain to the patient how to work with this system before using the virtual reality headset.
Category
Other
2
Description
Control group: The control group will not receive any of the above interventions and will only benefit from the routine and standard care applied in the emergency department of Imam Reza Hospital in Birjand, which includes only local anesthesia with 2% lidocaine. Be.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-Reza hospital
Full name of responsible person
Mohammadreza Ghasemian
Street address
Imam-Reza hospital, Taleghani Ave
City
Birjand
Province
South Khorasan
Postal code
971481151
Phone
+98 56 3222 2300
Email
international@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5833
Fax
+98 56 3163 5801
Email
drtooba.kazemi@gmail.com
Web page address
https://rsh.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Ali Sheikhalishahi
Position
M.Sc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghafari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 35 3722 0539
Email
alisheikhalishahi95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Manizhe Nasirizade
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghafari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1445
Email
m.nassirizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Sheikhalishahi
Position
M.Sc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghafari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 35 3722 0539
Email
alisheikhalishahi95@gmail.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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome will be available
When the data will become available and for how long