Pain ManagementPED-DISTRACTNCT07770191
Distraction Methods for Reducing Pain and Fear During Blood Draw in Children
A study testing 3D Hologram Viewing, Pinwheel Blowing and Gum Chewing in people with Pain Management and Fear, run by Gülsev Kutman at 1 site in Turkey (Türkiye).
Trial summary
Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Fear
- What is being tested?
- 3D Hologram Viewing, Pinwheel Blowing and Gum Chewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5 to 10 years
- Scheduled to undergo a blood draw
- No analgesic medication use within 6 hours before the procedure
- No visual, hearing, or speech impairment
- No neurological disorder
- No oral or jaw condition that may prevent gum chewing
Show all 9Show fewer
- No chronic illness requiring frequent invasive procedures
- Written informed consent provided by the parent or legal guardian
- Verbal assent provided by the children
Who cannot join
- Previous history of syncope during blood draw procedures
- Blood draw not completed on the first attempt
- Development of syncope during the procedure
- Inability or unwillingness to complete the assigned intervention
- Withdrawal of consent or assent by the parent or child at any stage of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tekirdağ City Hospital
Tekirdağ
About this study
Official title: Effects of Pinwheel Blowing, 3D Hologram Viewing, and Gum Chewing on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial
Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Parental satisfaction with the care provided during the procedure will also be evaluated.
A total of 164 children will be assigned in a 1:1:1:1 ratio to the pinwheel blowing, 3D hologram viewing, gum chewing, or control group using block randomization stratified by age and sex. The interventions will begin one minute before the blood draw and continue until the procedure is completed. Children in the control group will receive the routine blood draw procedure without any additional nonpharmacological intervention.
Immediately after the blood draw, the child's pain and fear during the procedure will be independently evaluated by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will also be assessed after the procedure.
Read the detailed description
This study is a four-arm, parallel-group randomized controlled trial involving children aged 5-10 years undergoing blood draw in a pediatric phlebotomy unit. The study aims to compare three nonpharmacological methods involving different mechanisms: active distraction through pinwheel blowing, passive visual distraction through 3D hologram viewing, and rhythmic oral and gustatory stimulation through flavored gum chewing.
Eligible children will be assigned to the study groups in a 1:1:1:1 ratio using block randomization stratified by sex (female or male) and age group (5-7 or 8-10 years). A block size of four will be used within each stratum.
In the pinwheel blowing group, children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. In the 3D hologram viewing group, children will watch an age-appropriate holographic video featuring colorful flying butterflies, beginning one minute before the blood draw and continuing until the procedure is completed. In the gum chewing group, children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue throughout the procedure. Children in the control group will receive the routine blood draw procedure without any additional pharmacological or nonpharmacological pain-relieving intervention. The accompanying parent will remain with the child throughout the procedure.
All blood draws will be performed by the same nurse, who has at least five years of pediatric phlebotomy experience, using a standardized procedure. Pain experienced during the blood draw will be assessed using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10. Fear will be assessed using the Children's Fear Scale, which ranges from 0 to 4. Immediately after the procedure, pain and fear will be rated independently by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will be evaluated using a single-item numerical rating scale ranging from 1 to 10.
Because of the visible nature of the interventions, the children, parents, researcher delivering the interventions, phlebotomy nurse, and observer nurse cannot be blinded to group allocation.
- Conditions
- Pain Management, Fear
- Being tested
- 3D Hologram Viewing, Pinwheel Blowing, Gum Chewing
- Keywords
- Distraction, 3D Hologram, Gum Chewing
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Hologram ViewingBehavioural
Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The holographic display will be positioned approximately 50 cm from the child. The intervention will begin one minute before the blood draw and continue until the procedure is completed.
Pinwheel BlowingBehavioural
Children blow a colorful handheld pinwheel with a diameter of 16 cm. The intervention begins one minute before the blood draw and continues until the procedure is completed. Children hold the pinwheel with the hand not used for blood collection; the researcher holds it when necessary.
Gum ChewingBehavioural
Children will select a 14.5-g piece of sugar-free flavored gum and begin chewing it one minute before the blood draw. The available flavors will include watermelon, strawberry, orange, and mixed fruit. Children will continue chewing the gum until the procedure is completed.
| Study group | Role | What they receive |
|---|---|---|
| 3D Hologram Viewing Group | Experimental | Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The intervention will begin one minute before the blood draw and continue until the procedure is completed. Receives: Behavioral: 3D Hologram Viewing |
| Pinwheel Blowing Group | Experimental | Children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. Receives: Behavioral: Pinwheel Blowing |
| Gum Chewing Group | Experimental | Children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue until the procedure is completed. Receives: Behavioral: Gum Chewing |
| Control Group | No intervention | Children will receive the routine blood draw procedure used in the pediatric phlebotomy unit. No additional pharmacological or nonpharmacological pain-relieving intervention will be provided. The accompanying parent will remain with the child and may talk to and maintain eye contact with the child during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale
Pain experienced during the blood draw will be assessed by the child using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces scored as 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Measured: Immediately after the blood draw, within approximately 5 minutes
Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale
Fear experienced during the blood draw will be assessed by the child using the Children's Fear Scale. The scale consists of five facial expressions scored from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear. Higher scores indicate greater fear.
Measured: Immediately after the blood draw, within approximately 5 minutes
Secondary outcomes (1)
Parent-Reported Satisfaction With the Blood Draw Procedure
Parental satisfaction with the care provided during the blood draw procedure will be assessed using a single-item numerical rating scale ranging from 1 to 10, where 1 indicates the lowest level of satisfaction and 10 indicates the highest level of satisfaction. Higher scores indicate greater parental satisfaction.
Measured: Immediately after the blood draw, within approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Jun 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Model description
- Participants are assigned to one of four parallel study groups: 3D hologram viewing, pinwheel blowing, gum chewing, or control.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gülsev Kutman
- Sponsor type
- Other government
- Collaborators
- Tekirdağ City Hospital
- Responsible party
- Sponsor-investigator, Gülsev Kutman, Corlu State Hospital
- Investigators
- Gülsev Kutman, Principal investigator, Tekirdağ City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770191
- Sponsor's protocol ID
- KUTMAN-PED-2026-01
- Acronym
- PED-DISTRACT
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent process and ethics committee approval did not include the sharing of participant-level data with other researchers. As the study involves children, participant privacy and confidentiality will be strictly protected. Only aggregate study findings will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pinwheel Blowing, 3D Hologram Viewing, and Gum Chewing on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07770191
- Acronym / sponsor ID
- PED-DISTRACT / KUTMAN-PED-2026-01
- Conditions
- Pain Management, Fear
- Keywords
- Distraction, 3D Hologram, Gum Chewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Gülsev KutmanOther government
- Collaborators
- Tekirdağ City Hospital
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 18 Aug 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.
Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Parental satisfaction with the care provided during the procedure will also be evaluated.
A total of 164 children will be assigned in a 1:1:1:1 ratio to the pinwheel blowing, 3D hologram viewing, gum chewing, or control group using block randomization stratified by age and sex. The interventions will begin one minute before the blood draw and continue until the procedure is completed. Children in the control group will receive the routine blood draw procedure without any additional nonpharmacological intervention.
Immediately after the blood draw, the child's pain and fear during the procedure will be independently evaluated by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will also be assessed after the procedure.
Detailed description
This study is a four-arm, parallel-group randomized controlled trial involving children aged 5-10 years undergoing blood draw in a pediatric phlebotomy unit. The study aims to compare three nonpharmacological methods involving different mechanisms: active distraction through pinwheel blowing, passive visual distraction through 3D hologram viewing, and rhythmic oral and gustatory stimulation through flavored gum chewing.
Eligible children will be assigned to the study groups in a 1:1:1:1 ratio using block randomization stratified by sex (female or male) and age group (5-7 or 8-10 years). A block size of four will be used within each stratum.
In the pinwheel blowing group, children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. In the 3D hologram viewing group, children will watch an age-appropriate holographic video featuring colorful flying butterflies, beginning one minute before the blood draw and continuing until the procedure is completed. In the gum chewing group, children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue throughout the procedure. Children in the control group will receive the routine blood draw procedure without any additional pharmacological or nonpharmacological pain-relieving intervention. The accompanying parent will remain with the child throughout the procedure.
All blood draws will be performed by the same nurse, who has at least five years of pediatric phlebotomy experience, using a standardized procedure. Pain experienced during the blood draw will be assessed using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10. Fear will be assessed using the Children's Fear Scale, which ranges from 0 to 4. Immediately after the procedure, pain and fear will be rated independently by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will be evaluated using a single-item numerical rating scale ranging from 1 to 10.
Because of the visible nature of the interventions, the children, parents, researcher delivering the interventions, phlebotomy nurse, and observer nurse cannot be blinded to group allocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are assigned to one of four parallel study groups: 3D hologram viewing, pinwheel blowing, gum chewing, or control.
| Arm | Type | Receives |
|---|---|---|
| 3D Hologram Viewing Group | Experimental | Behavioral: 3D Hologram ViewingChildren will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The intervention will begin one minute before the blood draw and continue until the procedure is completed. |
| Pinwheel Blowing Group | Experimental | Behavioral: Pinwheel BlowingChildren will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. |
| Gum Chewing Group | Experimental | Behavioral: Gum ChewingChildren will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue until the procedure is completed. |
| Control Group | No intervention | –Children will receive the routine blood draw procedure used in the pediatric phlebotomy unit. No additional pharmacological or nonpharmacological pain-relieving intervention will be provided. The accompanying parent will remain with the child and may talk to and maintain eye contact with the child during the procedure. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 5 to 10 years
- Scheduled to undergo a blood draw
- No analgesic medication use within 6 hours before the procedure
- No visual, hearing, or speech impairment
- No neurological disorder
Key exclusion criteria (5 listed)
- Previous history of syncope during blood draw procedures
- Blood draw not completed on the first attempt
- Development of syncope during the procedure
- Inability or unwillingness to complete the assigned intervention
- Withdrawal of consent or assent by the parent or child at any stage of the study
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 |
|---|---|---|
| 3D Hologram ViewingChildren will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The holographic display will be positioned approximately 50 cm from the child. The intervention will begin one minute before the blood draw and continue until the procedure is completed. | Behavioural | 3D Hologram Viewing Group |
| Pinwheel BlowingChildren blow a colorful handheld pinwheel with a diameter of 16 cm. The intervention begins one minute before the blood draw and continues until the procedure is completed. Children hold the pinwheel with the hand not used for blood collection; the researcher holds it when necessary. | Behavioural | Pinwheel Blowing Group |
| Gum ChewingChildren will select a 14.5-g piece of sugar-free flavored gum and begin chewing it one minute before the blood draw. The available flavors will include watermelon, strawberry, orange, and mixed fruit. Children will continue chewing the gum until the procedure is completed. | Behavioural | Gum Chewing Group |
Primary outcome
Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale
Time frame: Immediately after the blood draw, within approximately 5 minutes
Pain experienced during the blood draw will be assessed by the child using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces scored as 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale
Time frame: Immediately after the blood draw, within approximately 5 minutes
Fear experienced during the blood draw will be assessed by the child using the Children's Fear Scale. The scale consists of five facial expressions scored from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear. Higher scores indicate greater fear.
1 secondary outcome
Parent-Reported Satisfaction With the Blood Draw Procedure
Time frame: Immediately after the blood draw, within approximately 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent process and ethics committee approval did not include the sharing of participant-level data with other researchers. As the study involves children, participant privacy and confidentiality will be strictly protected. Only aggregate study findings will be reported in scientific publications.
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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.
Gülsev Kutman principal investigator
Tekirdağ City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Hologram Viewing, Pinwheel Blowing and Gum Chewing in people with Pain Management and Fear, run by Gülsev Kutman 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülsev Kutman, Rn Msc (0905521392671, glsvktmn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale (time frame: Immediately after the blood draw, within approximately 5 minutes). 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 18 Aug 2026.