Pediatric ALLIntravenousNCT07041216
Squishy Toy and Palpation in Pediatric IV Success
A study testing Squishy Toy Squeezing, Palpation and Routine medical care in people with Pediatric ALL, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effects of two non-pharmacological techniques-squishy toy squeezing and vein palpation-on the success rate of peripheral intravenous catheter (PIVC) insertion in pediatric hematology and oncology patients. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- Squishy Toy Squeezing, Palpation and Routine medical care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 31 Jul 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children identified by the healthcare team as needing peripheral intravenous catheter placement who also have a Difficult Intravenous Access (DIVA) score of 4 or above.
Who cannot join
- Children unable to squeeze a toy due to physical limitations were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University
Antalya, Antalya, (506) 508 62 14
About this study
Official title: The Effect of Squishy Toy Squeezing and Palpation Techniques on Peripheral Intravenous Catheter Insertion Success in Pediatric Hematology and Oncology: A Randomized Controlled Trial
This randomized controlled trial investigates the effects of two non-pharmacological techniques-squishy toy squeezing and vein palpation-on the success rate of peripheral intravenous catheter (PIVC) insertion in pediatric hematology and oncology patients. Data collection takes place in the procedure room of a pediatric outpatient clinic. The study includes children who have a Difficult Intravenous Access (DIVA) score of 4 or higher, indicating difficult venous access. Participants are randomly assigned to one of three groups: the squishy toy group, the palpation group, or the control group, which receives standard care.
In the squishy toy group, children use soft, elastic toys to activate hand muscles and improve blood flow, aiming to enhance vein visibility. In the palpation group, the target vein is gently tapped to increase local blood circulation and make the vein more prominent. The control group undergoes catheter insertion without any additional stimulation techniques. All data are recorded using structured forms that collect demographic, clinical, and procedural information. The study aims to determine whether these simple and cost-effective interventions improve the success rate of PIVC insertion in children with difficult venous access.
- Conditions
- Pediatric ALL
- Being tested
- Squishy Toy Squeezing, Palpation, Routine medical care
- Keywords
- Squishy Toy Squeezing, Peripheral Intravenous Catheter Insertion Success, Palpation Techniques, Pediatric Hematology and Oncology
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squishy Toy SqueezingOther
In the intervention group, vein suitability was checked using the DIVA score. A tourniquet was applied, the area was cleaned with antiseptic, and the child squeezed a squishy toy 10 times. Afterward,
PalpationOther
In this group, once the vein was identified, the area was gently tapped 8 to 10 times using the inner surfaces of four fingers to stimulate blood flow and enhance vein visibility. This light palpation helped increase local circulation, making the vein easier to access. After the tapping procedure, the area was thoroughly cleaned with an antiseptic solution. Once the skin was completely dry, the catheter was inserted under sterile conditions.
Routine medical careOther
This group received standard IV insertion with no extra techniques applied.
| Study group | Role | What they receive |
|---|---|---|
| Squishy Toy Group | Experimental | In the intervention group, vein suitability was checked using the DIVA score. A tourniquet was applied, the area was cleaned with antiseptic, and the child squeezed a squishy toy 10 times. Afterward, the child stopped using the toy. Once the vein was visible, the catheter was inserted and the tourniquet removed. Receives: Other: Squishy Toy Squeezing |
| Palpation Group | Experimental | In this group, once the vein was identified, the area was gently tapped 8 to 10 times using the inner surfaces of four fingers to stimulate blood flow and enhance vein visibility. This light palpation helped increase local circulation, making the vein easier to access. After the palpation procedure, the area was thoroughly cleaned with an antiseptic solution. Once the skin was completely dry, the catheter was inserted under sterile conditions. Receives: Other: Palpation |
| Control Group | Other | This group received standard IV insertion with no extra techniques applied. Receives: Other: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of IV attempts to successful acces
During the procedure, the number of intravenous catheter insertion attempts is measured using the catheter documentation form.
Measured: During the procedure
Time to successful acces
During the procedure, the total procedure time is measured using the catheter documentation form.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Dec 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies 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
- None (open label)
- Enrolment
- 90 participants (actual)
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
- NCT07041216
- Sponsor's protocol ID
- AkdenizUn
- Acronym
- Intravenous
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurcan M, Say B, Yayla N, Atay Turan S. Effectiveness of toy-mediated hand squeezing or palpation in peripheral IV catheterization among pediatric hematology and oncology patients: A randomized controlled trial. Eur J Oncol Nurs. 2025 Dec;79:103005. doi: 10.1016/j.ejon.2025.103005. Epub 2025 Oct 13.
PubMed 41166835
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Squishy Toy Squeezing and Palpation Techniques on Peripheral Intravenous Catheter Insertion Success in Pediatric Hematology and Oncology: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07041216
- Acronym / sponsor ID
- Intravenous / AkdenizUn
- Conditions
- Pediatric ALL
- Keywords
- Squishy Toy Squeezing, Peripheral Intravenous Catheter Insertion Success, Palpation Techniques, Pediatric Hematology and Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 27 Jun 2025 (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 the effects of two non-pharmacological techniques-squishy toy squeezing and vein palpation-on the success rate of peripheral intravenous catheter (PIVC) insertion in pediatric hematology and oncology patients. Data collection takes place in the procedure room of a pediatric outpatient clinic. The study includes children who have a Difficult Intravenous Access (DIVA) score of 4 or higher, indicating difficult venous access. Participants are randomly assigned to one of three groups: the squishy toy group, the palpation group, or the control group, which receives standard care.
In the squishy toy group, children use soft, elastic toys to activate hand muscles and improve blood flow, aiming to enhance vein visibility. In the palpation group, the target vein is gently tapped to increase local blood circulation and make the vein more prominent. The control group undergoes catheter insertion without any additional stimulation techniques. All data are recorded using structured forms that collect demographic, clinical, and procedural information. The study aims to determine whether these simple and cost-effective interventions improve the success rate of PIVC insertion in children with difficult venous access.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Squishy Toy Group | Experimental | Other: Squishy Toy SqueezingIn the intervention group, vein suitability was checked using the DIVA score. A tourniquet was applied, the area was cleaned with antiseptic, and the child squeezed a squishy toy 10 times. Afterward, the child stopped using the toy. Once the vein was visible, the catheter was inserted and the tourniquet removed. |
| Palpation Group | Experimental | Other: PalpationIn this group, once the vein was identified, the area was gently tapped 8 to 10 times using the inner surfaces of four fingers to stimulate blood flow and enhance vein visibility. This light palpation helped increase local circulation, making the vein easier to access. After the palpation procedure, the area was thoroughly cleaned with an antiseptic solution. Once the skin was completely dry, the catheter was inserted under sterile conditions. |
| Control Group | Other | Other: Routine medical careThis group received standard IV insertion with no extra techniques applied. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children identified by the healthcare team as needing peripheral intravenous catheter placement who also have a Difficult Intravenous Access (DIVA) score of 4 or above.
Key exclusion criteria (1 listed)
- Children unable to squeeze a toy due to physical limitations were excluded from 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 |
|---|---|---|
| Squishy Toy SqueezingIn the intervention group, vein suitability was checked using the DIVA score. A tourniquet was applied, the area was cleaned with antiseptic, and the child squeezed a squishy toy 10 times. Afterward, | Other | Squishy Toy Group |
| PalpationIn this group, once the vein was identified, the area was gently tapped 8 to 10 times using the inner surfaces of four fingers to stimulate blood flow and enhance vein visibility. This light palpation helped increase local circulation, making the vein easier to access. After the tapping procedure, the area was thoroughly cleaned with an antiseptic solution. Once the skin was completely dry, the catheter was inserted under sterile conditions. | Other | Palpation Group |
| Routine medical careThis group received standard IV insertion with no extra techniques applied. | Other | Control Group |
Primary outcome
Number of IV attempts to successful acces
Time frame: During the procedure
During the procedure, the number of intravenous catheter insertion attempts is measured using the catheter documentation form.
Time to successful acces
Time frame: During the procedure
During the procedure, the total procedure time is measured using the catheter documentation form.
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 22 Aug 2025.
- Derived from this study: PubMed 41166835Gurcan M, Say B, Yayla N, Atay Turan S. Effectiveness of toy-mediated hand squeezing or palpation in peripheral IV catheterization among pediatric hematology and oncology patients: A randomized controlled trial. Eur J Oncol Nurs. 2025 Dec;79:103005. doi: 10.1016/j.ejon.2025.103005. Epub 2025 Oct 13.
- 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.
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 Squishy Toy Squeezing, Palpation and Routine medical care in people with Pediatric ALL, run by Akdeniz 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 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: finished, as of the sponsor's last update on 22 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?
Number of IV attempts to successful acces (time frame: During 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?
On the ClinicalTrials.gov record for NCT07041216, which also lists 1 linked publication.
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 22 Aug 2025.