Determining the effect of using virtual reality on children's pain intensity and parents' satisfaction with pain management when suturing
Design
A clinical trial with with parallel control group, double-blind, randomize on 60 patients; Excel software was used for randomization.
Settings and conduct
This study is performed in Qazvin Trauma Center Hospital on children with trauma, the method of which was described above.
Participants/Inclusion and exclusion criteria
Study inclusion criteria: the child should be sutured to the limbs and body and referred to Rajai Hospital; age : 5 to 7 years old; no pain or other problem other than the pain of amputation; ability to communicate.
Exclusion criteria: any child who did not cooperate during the study (for example, refused to wear glasses or repeatedly removed the glasses from his eyes while stitching); parents who do not answer the research questions correctly. The need to use oral analgesics between suturing procedures.
Intervention groups
Initially, pain intensity in both intervention and control groups will be measured and compared using the instrument (VAS) before the intervention. In the control group, no intervention will be performed and routine affairs will be performed. In the intervention group, virtual glasses will be used 1 to 3 minutes before the start of the suturing procedure, so that a 5-minute animation in which the suturing method is performed. The treatment staff, which also has an educational aspect and is made by a researcher, will be broadcast to the child in 5 minutes in the form of games and animations, and then the intensity of pain will be measured in both groups.
Main outcome variables
Children's pain; cooperation with treatment staff; parental satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210613051567N1
Registration date:2021-08-19, 1400/05/28
Registration timing:registered_while_recruiting
Last update:2021-08-19, 1400/05/28
Update count:0
Registration date
2021-08-19, 1400/05/28
Registrant information
Name
Mahya Farmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 3132
Email address
mahyafarmanii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using virtual reality glasses on children's pain intensity and parents' satisfaction of pain management during suturing
Public title
Evaluation of the effect of virtual glasses on children's pain intensity and parental satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The child should be sutured to the limbs and body and referred to Rajai Hospital
Age: 5 to 7 years old
No pain or other problem other than the pain of amputation
Ability to communicate
No vision or hearing problems (based on initial history)
No psychological problems or mental retardation (based on initial history)
Do not use oral or injectable analgesics before entering the hospital
Exclusion criteria:
Any child who did not cooperate in the study (for example, refrained from wearing glasses or repeatedly removed glasses from their eyes while suturing)
Parents who do not answer the research questions correctly.
The need to use oral analgesics between suturing procedures.
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples are divided into simple and individual randomizations and first, on 60 pieces of paper, the number 1 was written as a sign of the intervention group or 2 as a sign of the control group. The papers were packed in small envelopes that looked exactly like each other, placed in a box, and when each child entered the ward, each child randomly selected one of the envelopes in the box and according to selected number 1 or 2 was placed in the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use virtual glasses to play 3D educational animation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
Nursing and Midwifery School of Tehran University of Medical Science; Mirkhani Street; Towhid Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TUMS.FNM.REC.1400.038
Health conditions studied
1
Description of health condition studied
Severe pain when the limb is sutured
ICD-10 code
G89.21
ICD-10 code description
Chronic pain due to
Primary outcomes
1
Description
Pain intensity during suturing and parental satisfaction with pain management
Timepoint
Pain intensity is measured half an hour before and immediately after suturing
Method of measurement
VAS pain measurement tool VAS and satisfaction is measured by a researcher-made questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: initially, pain intensity in the intervention group will be measured and compared using the instrument (VAS) before the intervention. In the intervention group, before entering the suture room, the correct use of glasses will be fully explained to children and parents, and then virtual glasses will be used 1 to 3 minutes before the start of the suturing procedure. A 5-minute animation in which the method of suturing by the medical staff, which also has an educational aspect and is made by a researcher, will be broadcast in 5 minutes as a game and animation for the child, and if the animation is completed and the procedure continues (which Usually lasts 5 to 10 minutes), the animation will be repeated and after the stitches are done, the glasses will be removed from the child's eyes and the severity of the child's pain will be measured. After suturing in the intervention group, it will be measured using a pain intensity test (Visual Analogue Scale). During the whole suturing work, one of the parents will be present with the child in the intervention group. All parents 'satisfaction will be measured using the Parents' Satisfaction Questionnaire for pain management half an hour after the intervention and suturing. Demographic information will also be asked of parents at the beginning of the sampling.
Category
Treatment - Devices
2
Description
Control group: 30 children will be randomly selected in the control group and the routine of the hospital will be performed for them and lidocaine will be used for anesthesia, but virtual glasses will not be used. After suturing the pain questionnaires (VAS) and parents' satisfaction with pain management, the child and parents will be given to collect data.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Truma Rajai Hospital
Full name of responsible person
Mahya Farmani
Street address
Shahid Rajaei Hospital, Safdari Alley, Padgan St.
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Fax
+98 28 3332 0105
Email
mahyafarmanii@gmail.com
Web page address
http://hosrajaee.qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Sadat Hosseini
Street address
Nursing and Midwifery school of Tehran University Of Medical Science. Mirkhani Street, Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Tehrantatrasht@gmail.com
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Mahya Farmani
Position
master student of pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school of Tehran University Of Medical Science. Mirkhani Street, Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Mahyafarmanii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahya Farmani
Position
master student of pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school of Tehran University Of Medical Science. Mirkhani Street, Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Mahyafarmanii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahya Farmani
Position
master student of pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school of Tehran University Of Medical Science. Mirkhani Street, Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Mahyafarmanii@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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Data are collected through two questionnaires of VAS and parental satisfaction with pain management and the results of the data are analyzed by skilled people and the pain is at the discretion of professors and treatment staff to use its beneficial results.
When the data will become available and for how long
After collecting the samples and analyzing them by statistical software, it will be possible to access the data results. The obtained data is also available during sampling
To whom data/document is available
Researchers, professors, consultants, supervisors, and treatment staff at the sampling site are allowed to access the data
Under which criteria data/document could be used
In order to improve the performance of the treatment staff and reduce stress and stress and pain of children and their families and in the conditions of achieving the expected results, the data can be used.
From where data/document is obtainable
To receive the documents and data after analyzing them, refer to the researcher or Tehran University of Medical Sciences
What processes are involved for a request to access data/document
To receive documents and data, the applicant can access the data by email to the researcher or by referring to Tehran University of Medical Sciences and learning the researcher's dissertation.