Child, OnlyNCT06576141
Kaleidoscope Virtual Reality Glasses Pain and Anxiety Levels in Venous Blood Collection Children
A study testing Kaleidoscope and Virtual Reality in people with Child, Only, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of our research is to investigate the effects of distracting children's attention with a kaleidoscope and virtual reality glasses during venous blood collection on perceived pain and anxiety levels. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only
- What is being tested?
- Kaleidoscope and Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Dec 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be between the ages of 9-12, The child and parents must agree to participate in the research, The child must be able to communicate and be open to communication, The child must not have any hearing, speech or vision disorders
Who cannot join
- The child is not within the age range specified above The child and parents do not agree to participate in the research. The child has a communication problem The child has a hearing, speech or vision disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
To Sakarya University Training and Research Hospital
Sakarya
metin yıldız, 02642953853, yildizz.metin@gmail.com
TUĞBA OLUÇ, NURSİNG
About this study
Official title: The Effect of Kaleidoscope and Virtual Reality Glasses on Pain and Anxiety Levels in Venous Blood Collection in Children Aged 9-12
The aim of our research is to investigate the effects of distracting children's attention with a kaleidoscope and virtual reality glasses during venous blood collection on perceived pain and anxiety levels.
Read the detailed description
After obtaining the necessary institutional permissions, parents and children who come to the blood collection room will be informed about the research through the "Informed Consent Form". The research data will be collected by the researcher using a face-to-face interview technique. Before the blood collection procedure, the children and their families who will be included in the kaleidoscope group, virtual reality group and control group will be informed about the research. The kaleidoscope will be used 5 minutes before the blood collection procedure as the child who will be included in the kaleidoscope group sits in the patient chair. The nurse will start preparing the child for the blood collection procedure at that time. The nurse will apply a tourniquet and determine the vein from the antecubital region to be taken from. The blood collection procedure will be taken from the antecubital region by the same nurse in one go using a vakuteynir (vacuum blood collection tube) and blood coming to the Vakuteynir within 5 seconds will indicate that the procedure was successful. This procedure will take approximately 2-3 minutes and the children will watch the kaleidoscope throughout the procedure. After the procedure is completed, the children will be taken out of the blood collection room and taken to the waiting area and the children will be asked to determine the level of pain they felt during the procedure. The child will assess how much fear the child experienced during the blood collection procedure and the level of anxiety.
The child who will be taken into the virtual reality group will be seated in the patient chair and virtual reality will be used 5 minutes before the blood collection procedure. The nurse will start preparing the child for the blood collection procedure at that time. The nurse will perform the tourniquet application and the determination of the vein from the antecubital region from which the blood will be taken. The blood collection procedure will be performed by the same nurse in one go from the antecubital region using a vakutainer (vacuum blood collection tube) and blood coming into the vakutainer within 5 seconds will indicate that the procedure was successful. This procedure will take approximately 2-3 minutes and the children will be shown virtual reality throughout the procedure. After the procedure is completed, the children will be taken out of the blood collection room and taken to the waiting area and the children will be asked to determine the level of pain they felt during the procedure. The child will assess how much fear the child experienced during the blood collection procedure and the level of anxiety they experienced. Children in the control group will not undergo any interventional procedures. Blood collection will be arranged to be taken from the antecubital region by the same nurse via a vacutainer. After the procedure is completed, children will be taken out of the blood collection room and taken to the waiting area. After being allowed to rest for 1-2 minutes, a questionnaire will be administered to the children. The child will evaluate how much fear the child has during the blood collection procedure and what their anxiety is. Children in the control group will not undergo any interventional procedures.
- Conditions
- Child, Only
- Being tested
- Kaleidoscope, Virtual Reality, control
- Keywords
- PAİN, Kaleidoscope, Venous Blood Collection, Anxiety, Virtual Reality Glasses, Children
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaleidoscopeOther
The participation of patients in this group in the study will take approximately 15-20 minutes.
Virtual RealityOther
The participation of patients in this group in the study will take approximately 15-20 minutes.
controlOther
The participation of patients in this group in the study will take approximately 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Kaleidoscope group | Active comparator | The kaleidoscope will be used 5 minutes before the blood collection procedure, as the child who will be included in the kaleidoscope group sits in the patient chair. The nurse will start preparing the child for the blood collection procedure at that time. Receives: Other: Kaleidoscope |
| virtual reality glasses | Active comparator | The child to be included in the virtual reality group will be seated in the patient chair and the virtual reality will be used 5 minutes before the blood collection procedure. The nurse will start preparing the child for the blood collection procedure at that time. Receives: Other: Virtual Reality |
| control group | Other | Children in the control group will not undergo any interventional procedures. Blood collection will be arranged to be taken from the antecubital region by the same nurse via a vacutainer. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expression Rating Scale (WB-FRS)
measuring fear
Measured: 1 year
State-Trait Anxiety Inventory for Children
measuring anxiety
Measured: 1 year
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 start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups. Kaleidoscope ,Virtual Reality Glasses and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba OLUÇ, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576141
- Sponsor's protocol ID
- EBYU-SBF-TO-01
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kaleidoscope and Virtual Reality Glasses on Pain and Anxiety Levels in Venous Blood Collection in Children Aged 9-12
- ClinicalTrials.gov ID
- NCT06576141
- Acronym / sponsor ID
- EBYU-SBF-TO-01
- Conditions
- Child, Only
- Keywords
- PAİN, Kaleidoscope, Venous Blood Collection, Anxiety, Virtual Reality Glasses, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- 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.
The aim of our research is to investigate the effects of distracting children's attention with a kaleidoscope and virtual reality glasses during venous blood collection on perceived pain and anxiety levels.
Detailed description
After obtaining the necessary institutional permissions, parents and children who come to the blood collection room will be informed about the research through the "Informed Consent Form". The research data will be collected by the researcher using a face-to-face interview technique. Before the blood collection procedure, the children and their families who will be included in the kaleidoscope group, virtual reality group and control group will be informed about the research. The kaleidoscope will be used 5 minutes before the blood collection procedure as the child who will be included in the kaleidoscope group sits in the patient chair. The nurse will start preparing the child for the blood collection procedure at that time. The nurse will apply a tourniquet and determine the vein from the antecubital region to be taken from. The blood collection procedure will be taken from the antecubital region by the same nurse in one go using a vakuteynir (vacuum blood collection tube) and blood coming to the Vakuteynir within 5 seconds will indicate that the procedure was successful. This procedure will take approximately 2-3 minutes and the children will watch the kaleidoscope throughout the procedure. After the procedure is completed, the children will be taken out of the blood collection room and taken to the waiting area and the children will be asked to determine the level of pain they felt during the procedure. The child will assess how much fear the child experienced during the blood collection procedure and the level of anxiety.
The child who will be taken into the virtual reality group will be seated in the patient chair and virtual reality will be used 5 minutes before the blood collection procedure. The nurse will start preparing the child for the blood collection procedure at that time. The nurse will perform the tourniquet application and the determination of the vein from the antecubital region from which the blood will be taken. The blood collection procedure will be performed by the same nurse in one go from the antecubital region using a vakutainer (vacuum blood collection tube) and blood coming into the vakutainer within 5 seconds will indicate that the procedure was successful. This procedure will take approximately 2-3 minutes and the children will be shown virtual reality throughout the procedure. After the procedure is completed, the children will be taken out of the blood collection room and taken to the waiting area and the children will be asked to determine the level of pain they felt during the procedure. The child will assess how much fear the child experienced during the blood collection procedure and the level of anxiety they experienced. Children in the control group will not undergo any interventional procedures. Blood collection will be arranged to be taken from the antecubital region by the same nurse via a vacutainer. After the procedure is completed, children will be taken out of the blood collection room and taken to the waiting area. After being allowed to rest for 1-2 minutes, a questionnaire will be administered to the children. The child will evaluate how much fear the child has during the blood collection procedure and what their anxiety is. Children in the control group will not undergo any interventional procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- There are three groups. Kaleidoscope ,Virtual Reality Glasses and control group
| Arm | Type | Receives |
|---|---|---|
| Kaleidoscope group | Active comparator | Other: KaleidoscopeThe kaleidoscope will be used 5 minutes before the blood collection procedure, as the child who will be included in the kaleidoscope group sits in the patient chair. The nurse will start preparing the child for the blood collection procedure at that time. |
| virtual reality glasses | Active comparator | Other: Virtual RealityThe child to be included in the virtual reality group will be seated in the patient chair and the virtual reality will be used 5 minutes before the blood collection procedure. The nurse will start preparing the child for the blood collection procedure at that time. |
| control group | Other | Other: controlChildren in the control group will not undergo any interventional procedures. Blood collection will be arranged to be taken from the antecubital region by the same nurse via a vacutainer. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The child must be between the ages of 9-12, The child and parents must agree to participate in the research, The child must be able to communicate and be open to communication, The child must not have any hearing, speech or vision disorders
Key exclusion criteria (1 listed)
- The child is not within the age range specified above The child and parents do not agree to participate in the research. The child has a communication problem The child has a hearing, speech or vision disorder.
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 |
|---|---|---|
| KaleidoscopeThe participation of patients in this group in the study will take approximately 15-20 minutes. | Other | Kaleidoscope group |
| Virtual RealityThe participation of patients in this group in the study will take approximately 15-20 minutes. | Other | virtual reality glasses |
| controlThe participation of patients in this group in the study will take approximately 5-10 minutes. | Other | control group |
Primary outcome
Wong-Baker Facial Expression Rating Scale (WB-FRS)
Time frame: 1 year
measuring fear
State-Trait Anxiety Inventory for Children
Time frame: 1 year
measuring anxiety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- 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.
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 and Virtual Reality in people with Child, Only, run by Erzincan Binali Yildirim Universitesi 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tuğba oluç, nursing ((0446) 226 6666, tugba.oluc@erzincan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Facial Expression Rating Scale (WB-FRS) (time frame: 1 year). 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 28 Aug 2024.