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Evaluation of the effect of virtual reality on pain reduction in emergency department patients during suture

Protocol summary

Study aim
Evaluation of the effect of virtual reality on pain relief in emergency department patients during suture
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 60.
Settings and conduct
In this research, all patients referred to the Emergency Department of Hazrat Rasoul Akram, Shohada-e- Haftome tir and Firouzgar Hospital, who needed suture will be enrolled. Patients will be randomly divided into two groups based on 10 blocks. A total of 120 patients will be examined. Data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Hazrat Rasoul Akram, Shohada-e- Haftome tir and Firouzgar Hospital, who needed suture will be enrolled. Inclusion criteria:Patients over 18 years, Patients without mental illness, Patients without mental retardation. Exclusion criteria: Patients over 70 years, Emergency hospitalized patients, Leave without notice or leave with personal consent, Patients who were transferred to the operating room and underwent surgery, Patient dissatisfaction.
Intervention groups
In control group, a common treatment will be performed, that is, only local anesthesia will be performed before the suture. and in intervention group, in addition to common treatment, local anesthesia will be performed before the suture and then the virtual reality glasses will be given to the patient during the suture.
Main outcome variables
Pain relief, Patient Satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151003024317N7
Registration date: 2019-09-01, 1398/06/10
Registration timing: prospective

Last update: 2019-09-01, 1398/06/10
Update count: 0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of virtual reality on pain reduction in emergency department patients during suture
Public title
Effect of Virtual reality on pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years Patients without mental illness Patients without mental retardation
Exclusion criteria:
Patients over 70 years Emergency hospitalized patients Leave without notice or leave with personal consent Patients who were transferred to the operating room and underwent surgery Patient dissatisfaction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 12 blocks will be considered for sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will be analyzed by person who is blind to study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.IUMS.REC.1398.547

Health conditions studied

1

Description of health condition studied
Virtual reality on pain relief during suture wounds
ICD-10 code
T14.1
ICD-10 code description
Open wound of unspecified body region

Primary outcomes

1

Description
Pain relief
Timepoint
Before the suture and during the suture
Method of measurement
From 1 to 5 (Based on numerical scale).

2

Description
Patient Satisfaction
Timepoint
At the time of discharge from the emergency department
Method of measurement
From 1 to 5 (based on Likert scale).

Secondary outcomes

empty

Intervention groups

1

Description
Control group:A common treatment will be performed, that is, only local anesthesia will be performed before the suture.
Category
Treatment - Drugs

2

Description
Intervention group: In addition to common treatment, local anesthesia will be performed before the suture and then the virtual reality glasses will be given to the patient during the suture.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e- Haftome tir Hospital
Full name of responsible person
Mahdi Rezai
Street address
Emergency Department, Shohada-e- Haftome tir Hospital, Shahid rajaee Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
Email
web7tir@iums.ac.ir

2

Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Mahdi Rezai
Street address
Emergency Department, Firouzgar hospital,Vali Asr Sq. Beh Afarin Ave.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

3

Recruitment center
Name of recruitment center
Hazrat Rasoul Akram hospital
Full name of responsible person
Mahdi Rezai
Street address
Emergency department, Hazrate Rasool hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
Email
hrmc@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevallian
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahdi Rezai
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Department, Firouzgar hospital,Vali Asr Sq. Beh Afarin Ave.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Email
mah_re@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahdi Rezai
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Department, Firouzgar hospital,Vali Asr Sq. Beh Afarin Ave.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
mah_re@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahdi Rezai
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Department, Firouzgar hospital,Vali Asr Sq. Beh Afarin Ave.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
mah_re@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
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
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