Pediatric HematologyNCT07493018
Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients
A study testing Performing a Hand Puppet to Music and Hand Squeezing Soft Toy (Squishy) in people with Pediatric Hematology and Pediatric Oncology, run by Akdeniz University.
Trial summary
This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Pediatric Hematology, Pediatric Oncology
- What is being tested?
- Performing a Hand Puppet to Music and Hand Squeezing Soft Toy (Squishy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Oct 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-10 years with a pediatric hematology or oncology diagnosis.
- Cognitively able to understand instructions during the procedure.
- Require peripheral IV catheter placement as determined by the healthcare team.
- Difficult Intravenous Access (DIVA) Score ≥4.
- Child and parent/guardian willing to participate.
Who cannot join
- Physical condition preventing use of a squeeze toy.
- Cognitive or developmental disorders preventing understanding of procedural instructions.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial
This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and first-attempt success.
- Conditions
- Pediatric Hematology, Pediatric Oncology
- Being tested
- Performing a Hand Puppet to Music, Hand Squeezing Soft Toy (Squishy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing a Hand Puppet to MusicOther
Children interact with a hand puppet chosen according to their preference during IV catheter placement. The puppet's playful movements and music aim to distract and reduce fear and emotional distress.
Hand Squeezing Soft Toy (Squishy)Other
Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention, reduces fear and distress, and helps them keep the procedure hand still. The toy is chosen by the child, hygienically managed, and given as a gift afterward. This simple, low-cost intervention aims to improve cooperation and IV placement success.
| Study group | Role | What they receive |
|---|---|---|
| Hand Puppet | Experimental | In this arm, an independent researcher will use a hand puppet with child-friendly animal or profession-themed designs, moving it to music during IV catheter placement to engage the child's attention. The child selects the puppet and interacts with it while another researcher collects data. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration. Receives: Other: Performing a Hand Puppet to Music |
| Squeeze Toy | Experimental | Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration. Receives: Other: Hand Squeezing Soft Toy (Squishy) |
| Control | No intervention | Children in the control group will receive standard peripheral IV catheter placement without any distraction techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
Time from start to successful IV catheter placement.
Measured: During procedure
Number of IV catheter attempts:
Recorded for each peripheral IV catheter placement.
Measured: During the IV procedure
Secondary outcomes (2)
Children's Fear Scale
A 5-point visual scale (0 = no fear, 4 = extreme fear) measuring children's anxiety and fear before and after the procedure. Applicable for children aged 5-10, can be completed by the child or observer.
Measured: Measured before and immediately after IV catheter placement
Children's Emotional Manifestation Scale
Observational tool evaluating emotional responses during stressful medical procedures across five categories (facial expression, vocalization, activity, interaction, cooperation). Each category scored 1-5; total score 5-25, with higher scores indicating more negative emotional responses.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric HematologyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Gürcan, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493018
- Sponsor's protocol ID
- AkdenizUnOncology
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.
PubMed 39002409Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17.
PubMed 39293201
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07493018
- Acronym / sponsor ID
- AkdenizUnOncology
- Conditions
- Pediatric Hematology, Pediatric Oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Mar 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.
This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and first-attempt success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hand Puppet | Experimental | Other: Performing a Hand Puppet to MusicIn this arm, an independent researcher will use a hand puppet with child-friendly animal or profession-themed designs, moving it to music during IV catheter placement to engage the child's attention. The child selects the puppet and interacts with it while another researcher collects data. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration. |
| Squeeze Toy | Experimental | Other: Hand Squeezing Soft Toy (Squishy)Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration. |
| Control | No intervention | –Children in the control group will receive standard peripheral IV catheter placement without any distraction techniques. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-10 years with a pediatric hematology or oncology diagnosis.
- Cognitively able to understand instructions during the procedure.
- Require peripheral IV catheter placement as determined by the healthcare team.
- Difficult Intravenous Access (DIVA) Score ≥4.
- Child and parent/guardian willing to participate.
Key exclusion criteria (3 listed)
- Physical condition preventing use of a squeeze toy.
- Cognitive or developmental disorders preventing understanding of procedural instructions.
- -
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 |
|---|---|---|
| Performing a Hand Puppet to MusicChildren interact with a hand puppet chosen according to their preference during IV catheter placement. The puppet's playful movements and music aim to distract and reduce fear and emotional distress. | Other | Hand Puppet |
| Hand Squeezing Soft Toy (Squishy)Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention, reduces fear and distress, and helps them keep the procedure hand still. The toy is chosen by the child, hygienically managed, and given as a gift afterward. This simple, low-cost intervention aims to improve cooperation and IV placement success. | Other | Squeeze Toy |
Primary outcome
Procedure duration
Time frame: During procedure
Time from start to successful IV catheter placement.
Number of IV catheter attempts:
Time frame: During the IV procedure
Recorded for each peripheral IV catheter placement.
2 secondary outcomes
Children's Fear Scale
Time frame: Measured before and immediately after IV catheter placement
Children's Emotional Manifestation Scale
Time frame: During procedure
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 30 Mar 2026.
- Background: PubMed 39002409Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.
- Background: PubMed 39293201Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Performing a Hand Puppet to Music and Hand Squeezing Soft Toy (Squishy) in people with Pediatric Hematology and Pediatric Oncology, run by Akdeniz University.
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 3 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Meltem Gürcan, PhD (+90 506 508 6214, meltemgurcan32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure duration (time frame: During 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?
On the ClinicalTrials.gov record for NCT07493018, which also lists 2 linked publications.
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 30 Mar 2026.