Procedural PainNCT07739381
Effects of Virtual Reality and Tablet Distraction During IV Cannulation in Children
A study testing Virtual Reality Distraction and Tablet Distraction in people with Procedural Pain and Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was conducted to evaluate the effects of virtual reality and tablet-based audiovisual distraction on pain, anxiety, and fear in children undergoing intravenous cannulation in a pediatric emergency department. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Anxiety, Fear
- What is being tested?
- Virtual Reality Distraction and Tablet Distraction
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- It was that the child belonged to the 7-12 age group and was fully conscious.
Who cannot join
- Children with hearing, cognitive, or visual impairments; children unaccompanied by a parent; children with whom communication cannot be established; and children with critical health issues and/or conditions requiring immediate intervention.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Evliya Çelebi Training and Research Hospital
Kütahya, Kütahya, 4300
About this study
Official title: The Effect of Watching an Entertaining Video With Virtual Reality Glasses and a Tablet on Pain, Anxiety, and Fear During Intravenous Cannulation in Children in the Emergency Department: A Randomized Controlled Trial
This randomized controlled trial was conducted to evaluate the effects of virtual reality and tablet-based audiovisual distraction on pain, anxiety, and fear in children undergoing intravenous cannulation in a pediatric emergency department. Children aged 7 to 12 years were randomly assigned to three groups: virtual reality, tablet, and control. During intravenous cannulation, children in the virtual reality group watched an entertaining video using a virtual reality headset, while children in the tablet group watched the same video on a tablet. Children in the control group received routine care without an audiovisual distraction intervention. Pain, anxiety, and fear were assessed using age-appropriate validated scales. The study compared the effects of the two distraction methods with routine care and with each other.
Read the detailed description
The study was designed as a randomized controlled trial involving children aged 7 to 12 years who required intravenous cannulation in a pediatric emergency department. Eligible participants were randomly assigned in a 1:1:1 ratio to a virtual reality group, a tablet group, or a control group.
Children assigned to the virtual reality group watched an entertaining audiovisual video using a virtual reality headset during intravenous cannulation. Children assigned to the tablet group watched the same video on a tablet during the procedure. Children in the control group underwent intravenous cannulation according to the routine clinical practice of the emergency department without an audiovisual distraction intervention.
Anxiety and fear were assessed immediately before intravenous cannulation and again five minutes after the procedure. Pain was assessed immediately after intravenous cannulation. The primary purpose of the study was to determine whether virtual reality and tablet-based distraction reduced procedure-related pain, anxiety, and fear and to compare the effectiveness of these interventions.
- Conditions
- Procedural Pain, Anxiety, Fear
- Being tested
- Virtual Reality Distraction, Tablet Distraction
- Keywords
- virtual reality, tablet, children, fear, anxiety
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionBehavioural
Children in the virtual reality group received virtual reality-based distraction during intravenous cannulation. A virtual reality headset was used to divert the child's attention from the procedure.
Tablet DistractionBehavioural
Children in the tablet group watched an age-appropriate cartoon on a tablet during intravenous cannulation to divert their attention from the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Children watched an age-appropriate entertaining video using a virtual reality headset during intravenous cannulation. Receives: Behavioral: Virtual Reality Distraction |
| tablet Group | Experimental | Children watched the same age-appropriate entertaining video on a tablet during intravenous cannulation. Receives: Behavioral: Tablet Distraction |
| control group | No intervention | Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Intravenous Cannulation
Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions representing increasing levels of pain. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed immediately after intravenous cannulation.
Measured: Immediately after intravenous cannulation
Secondary outcomes (1)
Anxiety Before and After Intravenous Cannulation
Anxety was assesed using the scale .Higher scores indicate greater anxiety.
Measured: Immediately before and immediately after intravenous cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Apr 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to the virtual reality, tablet, or control group.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Akkaya Balcı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739381
- Sponsor's protocol ID
- 2021/284
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Watching an Entertaining Video With Virtual Reality Glasses and a Tablet on Pain, Anxiety, and Fear During Intravenous Cannulation in Children in the Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07739381
- Acronym / sponsor ID
- 2021/284
- Conditions
- Procedural Pain, Anxiety, Fear
- Keywords
- virtual reality, tablet, children, fear, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial was conducted to evaluate the effects of virtual reality and tablet-based audiovisual distraction on pain, anxiety, and fear in children undergoing intravenous cannulation in a pediatric emergency department. Children aged 7 to 12 years were randomly assigned to three groups: virtual reality, tablet, and control. During intravenous cannulation, children in the virtual reality group watched an entertaining video using a virtual reality headset, while children in the tablet group watched the same video on a tablet. Children in the control group received routine care without an audiovisual distraction intervention. Pain, anxiety, and fear were assessed using age-appropriate validated scales. The study compared the effects of the two distraction methods with routine care and with each other.
Detailed description
The study was designed as a randomized controlled trial involving children aged 7 to 12 years who required intravenous cannulation in a pediatric emergency department. Eligible participants were randomly assigned in a 1:1:1 ratio to a virtual reality group, a tablet group, or a control group.
Children assigned to the virtual reality group watched an entertaining audiovisual video using a virtual reality headset during intravenous cannulation. Children assigned to the tablet group watched the same video on a tablet during the procedure. Children in the control group underwent intravenous cannulation according to the routine clinical practice of the emergency department without an audiovisual distraction intervention.
Anxiety and fear were assessed immediately before intravenous cannulation and again five minutes after the procedure. Pain was assessed immediately after intravenous cannulation. The primary purpose of the study was to determine whether virtual reality and tablet-based distraction reduced procedure-related pain, anxiety, and fear and to compare the effectiveness of these interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to the virtual reality, tablet, or control group.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual Reality DistractionChildren watched an age-appropriate entertaining video using a virtual reality headset during intravenous cannulation. |
| tablet Group | Experimental | Behavioral: Tablet DistractionChildren watched the same age-appropriate entertaining video on a tablet during intravenous cannulation. |
| control group | No intervention | –Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- It was that the child belonged to the 7-12 age group and was fully conscious.
Key exclusion criteria (1 listed)
- Children with hearing, cognitive, or visual impairments; children unaccompanied by a parent; children with whom communication cannot be established; and children with critical health issues and/or conditions requiring immediate intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality DistractionChildren in the virtual reality group received virtual reality-based distraction during intravenous cannulation. A virtual reality headset was used to divert the child's attention from the procedure. | Behavioural | Virtual Reality Group |
| Tablet DistractionChildren in the tablet group watched an age-appropriate cartoon on a tablet during intravenous cannulation to divert their attention from the procedure. | Behavioural | tablet Group |
Primary outcome
Pain During Intravenous Cannulation
Time frame: Immediately after intravenous cannulation
Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions representing increasing levels of pain. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed immediately after intravenous cannulation.
1 secondary outcome
Anxiety Before and After Intravenous Cannulation
Time frame: Immediately before and immediately after intravenous cannulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Distraction and Tablet Distraction in people with Procedural Pain and Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Intravenous Cannulation (time frame: Immediately after intravenous cannulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.