Pain, ProceduralNCT06466551
Effect of Virtual Reality Goggles and Stress Ball Use on Pain and Fear During IV Catheterization in Children
A study testing intravenous catheterization in people with Pain, Procedural and Anxiety, run by Toros University at 1 site in Turkey (Türkiye).
Trial summary
Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural, Anxiety, Pain Management
- What is being tested?
- intravenous catheterization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 1 Apr 2025
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12 years
- Admitted to the pediatric unit of the hospital between June 20, 2024, and April 20, 2025
- Scheduled to undergo intravenous catheterization
- Having parental consent through a signed informed consent form
- Absence of mental or developmental retardation
Who cannot join
- Children for whom the first attempt at intravenous catheterization was unsuccessful
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children: A Randomized Experimental Study
Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.
Read the detailed description
Provide a brief summary of the study, including the purpose, objectives, and brief methodology.
- Conditions
- Pain, Procedural, Anxiety, Pain Management
- Being tested
- intravenous catheterization
- Keywords
- distraction, fear, pain
- Medical subject headings
- Pain, Procedural, Anxiety Disorders, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous catheterizationOther
This randomized experimental study was planned to examine the effect of virtual reality goggles and squeezing a stress ball as a distraction method during intravenous catheter application on pain and fear in children aged 6-12 years.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Goggles Group | Experimental | Children in this group watched cartoons using virtual reality goggles starting 3 minutes before intravenous catheterization. Pain and fear were assessed before, during, and after the procedure. Receives: Other: intravenous catheterization |
| Stress Ball Group | Experimental | Children in this group used a stress ball as a distraction method starting 3 minutes before intravenous catheterization. Pain and fear were assessed before, during, and after the procedure. Receives: Other: intravenous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale
Pain scores will be measured using the Wong-Baker FACES Pain Rating Scale. Scores will be recorded before, during, and after intravenous catheterization. Pain will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Pain will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).
Measured: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Change in Fear Scores Assessed by the Children's Fear Scale
Fear levels will be assessed using the Children's Fear Scale. Scores will be recorded before, during, and after intravenous catheterization. Fear will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Fear will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).
Measured: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 Jun 2024
- Primary completion20 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Polat Kulcu, Toros University
- Investigators
- Didem Polat Külcü, Dr., Principal investigator, Toros University, Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466551
- Sponsor's protocol ID
- Toros
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared for secondary research purposes upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children: A Randomized Experimental Study
- ClinicalTrials.gov ID
- NCT06466551
- Acronym / sponsor ID
- Toros
- Conditions
- Pain, Procedural, Anxiety, Pain Management
- Keywords
- distraction, fear, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 20 Jun 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.
Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.
Detailed description
Provide a brief summary of the study, including the purpose, objectives, and brief methodology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Goggles Group | Experimental | Other: intravenous catheterizationChildren in this group watched cartoons using virtual reality goggles starting 3 minutes before intravenous catheterization. Pain and fear were assessed before, during, and after the procedure. |
| Stress Ball Group | Experimental | Other: intravenous catheterizationChildren in this group used a stress ball as a distraction method starting 3 minutes before intravenous catheterization. Pain and fear were assessed before, during, and after the procedure. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-12 years
- Admitted to the pediatric unit of the hospital between June 20, 2024, and April 20, 2025
- Scheduled to undergo intravenous catheterization
- Having parental consent through a signed informed consent form
- Absence of mental or developmental retardation
Key exclusion criteria (1 listed)
- Children for whom the first attempt at intravenous catheterization was unsuccessful
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 |
|---|---|---|
| intravenous catheterizationThis randomized experimental study was planned to examine the effect of virtual reality goggles and squeezing a stress ball as a distraction method during intravenous catheter application on pain and fear in children aged 6-12 years. | Other | Stress Ball Group, Virtual Reality Goggles Group |
Primary outcome
Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale
Time frame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Pain scores will be measured using the Wong-Baker FACES Pain Rating Scale. Scores will be recorded before, during, and after intravenous catheterization. Pain will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Pain will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).
Change in Fear Scores Assessed by the Children's Fear Scale
Time frame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Fear levels will be assessed using the Children's Fear Scale. Scores will be recorded before, during, and after intravenous catheterization. Fear will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Fear will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).
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 13 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared for secondary research purposes upon reasonable request.
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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.
Didem Polat Külcü, Dr. principal investigator
Toros University, Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous catheterization in people with Pain, Procedural and Anxiety, run by Toros 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 5 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 13 Aug 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?
Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale (time frame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)). The study lists 2 primary outcomes in all. 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 13 Aug 2025.