Study and comparison of the effects of virtual reality and vibrator combined with cold on pain, fear, and anxiety caused by venipuncture in children referred to the pediatric emergency department of Hakim Hospital
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 177 children. A permutational block design was used for randomization.
Settings and conduct
Study location: Pediatric emergency room of Hakim Hospital in Neyshabur; Study population: Children aged 6 to 12 years who referred to the emergency room; Type of blinding: Single-sided blinding; Method of blinding: The research assistant completes the questionnaires after the child leaves the venipuncture room. The research assistant is unaware of the intervention performed in the venipuncture room.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Need for intravenous line placement; willingness of parents and child to participate in the study. Exclusion criteria: Diagnosed cognitive, mental disorders, hearing and vision impairments; The child's condition is urgent.
Intervention groups
Intervention group 1: Virtual reality group: Before the child enters the venipuncture room, virtual reality glasses are placed on the child's face, and the child enters the venipuncture room while watching their favorite animation, and the glasses will remain on the child's face until the end of the procedure.
Intervention group 2: Local cold with vibration group: 30 to 60 seconds before the start of venipuncture, a vibrating doll's tourniquet with an ice pack at the bottom is placed 3-5 cm above the venipuncture site and remains in place until the end of venipuncture.
Control group: No intervention is performed other than routine care.
Main outcome variables
Pain, fear, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041960N3
Registration date:2025-12-12, 1404/09/21
Registration timing:prospective
Last update:2025-12-12, 1404/09/21
Update count:0
Registration date
2025-12-12, 1404/09/21
Registrant information
Name
Fateme Avizhgan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4487 3295
Email address
avizhgan_f@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-02-19, 1404/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of virtual reality with a vibrator combined with cold on pain, anxiety, and fear caused by venipuncture children
Public title
Comparing the effects of virtual reality with a vibrator combined with cold on pain, anxiety, and fear caused by venipuncture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Need for intravenous line
Willingness of parents and child to participate in the study
Exclusion criteria:
Diagnosed cognitive and mental disorders, hearing and vision
The child's condition is urgent.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
177
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, non-probability and convenience sampling will be used in such a way that samples that meet the inclusion criteria will be included in the study. To randomly assign the sample to three groups (Group A, Group B, Group C), the permutation block allocation method will be used. In this study, blocks will be created in 3 pieces. First, all the states are determined.
1.ABC 2. ACB 3.BAC 4.BCA 5.CAB 6.CBA
Then, using the software to determine the permutation blocks, the desired blocks are created from the above 6 blocks using permutation sampling. Finally, 59 blocks of 3 were created, which are presented in a separate file attached to the proposal. In this process, 177 children are examined. In each block, there are three groups A, B, and C.
Blinding (investigator's opinion)
Single blinded
Blinding description
When the child leaves the venipuncture room, the questionnaires are completed by a research associate who is unaware of the type of intervention performed on the child during venipuncture.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University of Medical Sciences
Street address
Neyshabur University of Medical Sciences, End of Eslami Moqavemat Boulevard, Andisheh Town, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9657876543
Approval date
2025-07-20, 1404/04/29
Ethics committee reference number
IR.NUMS.REC.1404.023
Health conditions studied
1
Description of health condition studied
Intravenous line placement
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before entering the venipuncture room, immediately after leaving the venipuncture room, and 5 minutes after completion of venipuncture.
Method of measurement
Usher Standard Pain Assessment Tool
2
Description
Anxiety
Timepoint
Before entering the venipuncture room, immediately after leaving the venipuncture room, and 5 minutes after completion of venipuncture.
Method of measurement
Observational Scale of Behavioral Distress- Revised
3
Description
Fear
Timepoint
Before entering the venipuncture room, immediately after leaving the venipuncture room, and 5 minutes after completion of venipuncture.
Method of measurement
Children's Fear Scale (CFS)
Secondary outcomes
1
Description
Pulse
Timepoint
Immediately after completion of venipuncture
Method of measurement
Counting pulse
2
Description
Breathing
Timepoint
Immediately after completion of venipuncture
Method of measurement
Breath counting
Intervention groups
1
Description
Intervention group 1: In the virtual reality group, before the child enters the venipuncture room, headphones and virtual reality glasses are placed on the child's face. The child enters the venipuncture room while watching their favorite animation, and the glasses will remain on the child's face until the end of the procedure.
Category
Behavior
2
Description
Intervention group 2: In the local cold with vibration group, the venipuncture procedure is performed by the responsible nurse 30 to 60 seconds before the start of the venipuncture, 3-5 cm above the venipuncture site, a doll garrote that produces vibration (vibration is performed by a vibration motor placed inside the doll's body). An ice bag is attached to the bottom of it and remains in place until the end of the venipuncture. At the end of each venipuncture, the device is disinfected with a 70% alcohol solution and stored in the ward refrigerator (the ice storage part is separated from the vibrator motor).
Category
Behavior
3
Description
Control group: In the control group, no intervention other than routine care is provided.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim hospital
Full name of responsible person
Fatemeh Avijgan
Street address
End of Moqavemat Islami Boulevard, Andisheh Town.
City
Neyshabur
Province
Razavi Khorasan
Postal code
9657654334
Phone
+98 51 4465 9373
Email
AVIJGAN.S@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Ali Gholami
Street address
End of Moqavemat Islami Boulevard, Andisheh Town.
City
Neyshabur
Province
Razavi Khorasan
Postal code
6543211234
Phone
+98 51 4465 9373
Email
golami.123@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Fatemeh Avijgan
Position
Mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
End of Moqavemat Islami Boulevard, Andisheh Town.
City
Neyshabur
Province
Razavi Khorasan
Postal code
8765432178
Phone
+98 51 4465 9373
Email
avijgan.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Fatemeh Avijgan
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
End of Moqavemat Islami Boulevard, Andisheh Town.
City
Neyshabur
Province
Razavi Khorasan
Postal code
9657686534
Phone
+98 51 4465 9373
Email
Avijgan.s@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Fatemeh Avijgan
Position
mentor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
End of Moqavemat Islami Boulevard, Andisheh Town.
City
Neyshabur
Province
Razavi Khorasan
Postal code
9657654378
Phone
+98 51 4465 9373
Email
avijgan.s@gmail.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