PainNCT06575816
Effect of Augmented Reality on Pain, Anxiety, and Fear in Children During Blood Collection
A study testing Augmented Reality Video Intervention in people with Pain and Fear, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In recent years, technological advances have enabled the development of innovative intervention methods in healthcare. This study aims to examine the effect of augmented reality (AR) technology on pain, anxiety and fear in children during pediatric blood collection procedures. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- What is being tested?
- Augmented Reality Video Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 2 Sep 2024
- 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Both parent and child voluntarily agree to participate in the study
- No language barrier
Who cannot join
- Parents or children who refused to participate in the study
- Problems with looking at the screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Augmented Reality on Pain, Anxiety and Fear During Blood Collection in Children: Randomized Controlled Study
In recent years, technological advances have enabled the development of innovative intervention methods in healthcare. This study aims to examine the effect of augmented reality (AR) technology on pain, anxiety and fear in children during pediatric blood collection procedures. The study is based on a randomized controlled design. Participants were randomized into two groups, the group receiving AR intervention and the control group receiving standard care. Pain, anxiety and fear levels will be assessed with pre and post intervention measurements.
- Being tested
- Augmented Reality Video Intervention
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Video InterventionBehavioural
This intervention involves a video intervention using augmented reality (AR) technology to reduce the pain, anxiety and fear children experience during the blood collection process. During the intervention, children watch AR videos to distract and relax them from the blood collection process. These videos are equipped with a variety of entertaining and engaging content and aim to reduce children's psychological stress.
| Study group | Role | What they receive |
|---|---|---|
| Control group, intervention group | Active comparator | This group will receive the standard blood collection procedure without any augmented reality video intervention. Pain, anxiety, and fear levels will be assessed using standardized scales after the procedure.
This group will receive the augmented reality video intervention during the blood collection procedure. The intervention consists of children watching AR videos designed to distract and comfort them during the blood draw. Pain, anxiety, and fear levels will be measured using standardized scales immediately after the procedure. Receives: Behavioral: Augmented Reality Video Intervention |
| Control group | No intervention | This group will receive the standard blood collection procedure without any augmented reality video intervention. Pain, anxiety, and fear levels will be assessed using standardized scales after the procedure. |
| intervention group | Experimental | This group will receive the augmented reality video intervention during the blood collection procedure. The intervention consists of children watching AR videos designed to distract and comfort them during the blood draw. Pain, anxiety, and fear levels will be measured using standardized scales immediately after the procedure. Receives: Behavioral: Augmented Reality Video Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Children's pain levels will be measured using a standardized pain scale, such as the Wong-Baker Pain Rating Scale, immediately after the blood collection procedure.The scale can be scored from a minimum of 0 to a maximum of 10. As the score increases, pain increases.
Measured: Five minutes before and 5 minutes after blood collection
Secondary outcomes (1)
Fear Level
Children's fear levels will be evaluated using a fear assessment tool, such as the Children's Fear Scale, before and after the blood collection procedure.
The scale can be scored from a minimum of 0 to a maximum of 4. As the score increases, fear increases.
Measured: Five minutes before and 5 minutes after blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start30 Mar 2024
- Primary completion30 Aug 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Zahide Özdemir, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575816
- Sponsor's protocol ID
- DokuzEU-2024
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozdemir EZ, Ozkaya IN, Ciftci R, Bektas M. Effects of tablet-based augmented reality on anxiety, fear, and pain during venipuncture in children: a randomized controlled trial. BMC Pediatr. 2026 Jul 6. doi: 10.1186/s12887-026-07214-6. Online ahead of print.
PubMed 42410411
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Augmented Reality on Pain, Anxiety and Fear During Blood Collection in Children: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06575816
- Acronym / sponsor ID
- DokuzEU-2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 28 Aug 2024 (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.
In recent years, technological advances have enabled the development of innovative intervention methods in healthcare. This study aims to examine the effect of augmented reality (AR) technology on pain, anxiety and fear in children during pediatric blood collection procedures. The study is based on a randomized controlled design. Participants were randomized into two groups, the group receiving AR intervention and the control group receiving standard care. Pain, anxiety and fear levels will be assessed with pre and post intervention measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group, intervention group | Active comparator | Behavioral: Augmented Reality Video InterventionThis group will receive the standard blood collection procedure without any augmented reality video intervention. Pain, anxiety, and fear levels will be assessed using standardized scales after the procedure. This group will receive the augmented reality video intervention during the blood collection procedure. The intervention consists of children watching AR videos designed to distract and comfort them during the blood draw. Pain, anxiety, and fear levels will be measured using standardized scales immediately after the procedure. |
| Control group | No intervention | –This group will receive the standard blood collection procedure without any augmented reality video intervention. Pain, anxiety, and fear levels will be assessed using standardized scales after the procedure. |
| intervention group | Experimental | Behavioral: Augmented Reality Video InterventionThis group will receive the augmented reality video intervention during the blood collection procedure. The intervention consists of children watching AR videos designed to distract and comfort them during the blood draw. Pain, anxiety, and fear levels will be measured using standardized scales immediately after the procedure. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Both parent and child voluntarily agree to participate in the study
- No language barrier
Key exclusion criteria (2 listed)
- Parents or children who refused to participate in the study
- Problems with looking at the screen
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 |
|---|---|---|
| Augmented Reality Video InterventionThis intervention involves a video intervention using augmented reality (AR) technology to reduce the pain, anxiety and fear children experience during the blood collection process. During the intervention, children watch AR videos to distract and relax them from the blood collection process. These videos are equipped with a variety of entertaining and engaging content and aim to reduce children's psychological stress. | Behavioural | Control group, intervention group, intervention group |
Primary outcome
Pain Level
Time frame: Five minutes before and 5 minutes after blood collection
Children's pain levels will be measured using a standardized pain scale, such as the Wong-Baker Pain Rating Scale, immediately after the blood collection procedure.The scale can be scored from a minimum of 0 to a maximum of 10. As the score increases, pain increases.
1 secondary outcome
Fear Level
Time frame: Five minutes before and 5 minutes after blood collection
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 17 Apr 2025.
- Derived from this study: PubMed 42410411Ozdemir EZ, Ozkaya IN, Ciftci R, Bektas M. Effects of tablet-based augmented reality on anxiety, fear, and pain during venipuncture in children: a randomized controlled trial. BMC Pediatr. 2026 Jul 6. doi: 10.1186/s12887-026-07214-6. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Augmented Reality Video Intervention in people with Pain and Fear, run by Dokuz Eylul 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 2 inclusion and 2 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 17 Apr 2025. 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 Level (time frame: Five minutes before and 5 minutes after blood collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575816, which also lists 1 linked publication.
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 17 Apr 2025.