Child BehaviorNCT05533827
The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions
A study testing Kaleidoscope, Music and Virtual reality glasses in people with Child Behavior, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Child Behavior
- What is being tested?
- Kaleidoscope, Music and Virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Dec 2021
- 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
- No healthy volunteers
- Child
Who may be able to join
- The child is between the ages of 7 and 12
- Admission of the child to the pediatric emergency service for diagnosis and treatment
- The child's general condition is stable
- Deciding on one of the interventions such as blood collection, vascular access, deltoid region intramuscular injection after the examination, and the absence of any other invasive intervention planning
- The fact that the invasive intervention was performed in one go
- The child does not have vision and hearing problems
Show all 12Show fewer
- The child has no pain (due to the disease, drug side effects, distension)
- The child does not have a chronic disease (kidney, diabetes, etc.) that will require frequent invasive procedures.
- The child's mental development level to be able to answer the questions asked
- The child and parent speak and understand Turkish comfortably
- The children and their parents are willing to participate in the research.
- Parents give written consent
Who cannot join
- The child has a history of epilepsy, vertigo and neurological disease
- Having a history of fainting during blood draw
- Having a disease that causes chronic pain
- Wearing glasses or hearing aids
- Complication development during invasive intervention (allergy, syncope, etc.)
- If the child is in danger of life and is taken to the very urgent patient examination room (resuscitation room)
- Deciding that the child is a forensic case after the examination
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Banıdrma Onyedi Eylul University
Bandırma, Balıkesir
About this study
Official title: The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical
This study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music concert, virtual reality glasses) is a randomized controlled experimental study to determine the effect of children on pain, anxiety and fear of medical procedures.
- Conditions
- Child Behavior
- Being tested
- Kaleidoscope, Music, Virtual reality glasses
- Keywords
- music, Kaleidoscope, virtual reality glasses
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaleidoscopeOther
Kaleidoscope
MusicOther
Music
Virtual reality glassesOther
Virtual reality glasses
| Study group | Role | What they receive |
|---|---|---|
| Kaleidoscope | Experimental | Kaleidoscope Receives: Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses |
| Music | Experimental | Music listening Receives: Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses |
| Virtual reality glasses | Experimental | Virtual reality glasses Receives: Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain level
Measured: 5 minutes before intervention
Pain level
Pain level
Measured: 5 minutes after intervention
Anxiety level
Anxiety level
Measured: 5 minutes before intervention
Anxiety level
Anxiety level
Measured: 5 minutes after intervention
Fear of medical procedures
Fear of medical procedures
Measured: 5 minutes before intervention
Fear of medical procedures
Fear of medical procedures
Measured: 5 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Jun 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursen Goktas, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533827
- Sponsor's protocol ID
- BandirmaOnyediEylulUU
- Status last verified
- Sep 2022
- First submitted
- 17 Aug 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical
- ClinicalTrials.gov ID
- NCT05533827
- Acronym / sponsor ID
- BandirmaOnyediEylulUU
- Conditions
- Child Behavior
- Keywords
- music, Kaleidoscope, virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Sep 2022 (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 study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music concert, virtual reality glasses) is a randomized controlled experimental study to determine the effect of children on pain, anxiety and fear of medical procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kaleidoscope | Experimental | Other: Kaleidoscope, Other: Music, Other: Virtual reality glassesKaleidoscope |
| Music | Experimental | Other: Kaleidoscope, Other: Music, Other: Virtual reality glassesMusic listening |
| Virtual reality glasses | Experimental | Other: Kaleidoscope, Other: Music, Other: Virtual reality glassesVirtual reality glasses |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- The child is between the ages of 7 and 12
- Admission of the child to the pediatric emergency service for diagnosis and treatment
- The child's general condition is stable
- Deciding on one of the interventions such as blood collection, vascular access, deltoid region intramuscular injection after the examination, and the absence of any other invasive intervention planning
- The fact that the invasive intervention was performed in one go
Key exclusion criteria (7 listed)
- The child has a history of epilepsy, vertigo and neurological disease
- Having a history of fainting during blood draw
- Having a disease that causes chronic pain
- Wearing glasses or hearing aids
- Complication development during invasive intervention (allergy, syncope, etc.)
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 |
|---|---|---|
| KaleidoscopeKaleidoscope | Other | Kaleidoscope, Music, Virtual reality glasses |
| MusicMusic | Other | Kaleidoscope, Music, Virtual reality glasses |
| Virtual reality glassesVirtual reality glasses | Other | Kaleidoscope, Music, Virtual reality glasses |
Primary outcome
Pain level
Time frame: 5 minutes before intervention
Pain level
Pain level
Time frame: 5 minutes after intervention
Pain level
Anxiety level
Time frame: 5 minutes before intervention
Anxiety level
Anxiety level
Time frame: 5 minutes after intervention
Anxiety level
Fear of medical procedures
Time frame: 5 minutes before intervention
Fear of medical procedures
Fear of medical procedures
Time frame: 5 minutes after intervention
Fear of medical procedures
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 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Child Behavior
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
Digital Behavioral Parenting Programs With and Without Added Emotion Regulation Strategies to Manage Anger in Parenting
Parenting Intervention, Anger
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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 Kaleidoscope, Music and Virtual reality glasses in people with Child Behavior, run by Bandırma Onyedi Eylül 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 12 inclusion and 7 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 9 Sep 2022. 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: 5 minutes before intervention). The study lists 6 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 9 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.