Procedural Fear in ChildrenNCT07459517
Effect of a Musical-Moving Toy Used During Difficult Peripheral Intravenous Catheterization on Children's Fear Level and Procedure Success
A study testing Musical-Moving Toy Distraction in people with Procedural Fear in Children and Difficult Intravenous Access, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral intravenous catheterization (PIVC) is a frequently performed invasive procedure in pediatric emergency departments and is often associated with fear and distress in children. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Fear in Children, Difficult Intravenous Access
- What is being tested?
- Musical-Moving Toy Distraction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2024to 28 Feb 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-6 years
- Children requiring peripheral intravenous catheterization in the pediatric emergency department
- Children with a Difficult Intravenous Access (DIVA) score ≥4
- Children whose parents or legal guardians provide informed consent for participation
Who cannot join
- Children with cognitive or developmental disorders that may interfere with fear assessment
- Children with visual or hearing impairments preventing interaction with the distraction toy
- Children who require urgent or life-saving interventions
- Children whose parents decline participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Musical-Moving Toy Used During Difficult Peripheral Intravenous Catheterization on Children's Fear Level and Procedure Success: A Randomized Controlled Trial
Peripheral intravenous catheterization (PIVC) is a frequently performed invasive procedure in pediatric emergency departments and is often associated with fear and distress in children. Children with difficult intravenous access (DIVA) may require multiple attempts for successful catheterization, which can increase fear, anxiety, and procedure time. Non-pharmacological distraction techniques are commonly used to reduce procedural distress in children.
This randomized controlled study aims to evaluate the effect of a musical-moving toy used as a distraction method during peripheral intravenous catheterization on children's fear levels, procedure success, and procedure duration. The study will be conducted in the pediatric emergency department of Antalya City Hospital in Türkiye.
Read more
Children aged 4-6 years with difficult intravenous access will be randomly assigned to either an intervention group or a control group. In the intervention group, a musical-moving toy will be used during the catheterization procedure to distract the child, while the control group will receive standard care without the toy.
Fear levels will be measured using the Children's Fear Scale. Procedure success will be evaluated by the number of attempts required to successfully insert the catheter, and procedure duration will be recorded using a stopwatch.
The findings of this study may contribute to improving pediatric procedural care by providing an effective, low-cost, and easily applicable distraction method during intravenous catheterization.
Read the detailed description
Peripheral intravenous catheterization (PIVC) is one of the most commonly performed invasive procedures in pediatric emergency departments for the administration of fluids, medications, and blood products. However, PIVC procedures can cause significant fear, anxiety, and distress in children. These negative experiences may lead to behavioral reactions such as crying, resistance, and refusal of treatment, which may complicate the procedure and increase procedure duration.
Children with difficult intravenous access (DIVA) represent a particularly challenging group, as multiple attempts may be required to successfully place a catheter. Previous research has shown that non-pharmacological distraction techniques can reduce pain, fear, and anxiety during invasive procedures in children. These techniques are inexpensive, easy to implement, and widely used in pediatric nursing practice.
Various distraction methods such as cartoons, balloon inflation, virtual reality, and distraction cards have been investigated in previous studies. However, limited evidence exists regarding the effectiveness of musical-moving toys as a distraction method during difficult intravenous catheterization procedures in young children.
This study is designed as a randomized controlled trial to evaluate the effect of a musical-moving toy used during PIVC procedures on children's fear level, procedure success, and procedure duration. The study will be conducted in the pediatric emergency department blood collection room of Antalya City Hospital.
A total of 68 children aged 4-6 years with a Difficult Intravenous Access Score (DIVA score) of 4 or higher will be included in the study. Participants will be randomly assigned to either an intervention group (n=34) or a control group (n=34) using simple randomization.
In the intervention group, a musical-moving toy will be used during the PIVC procedure to distract the child. The control group will receive standard care without the distraction intervention.
Data will be collected using a Child Information Form, the Difficult Intravenous Access Score (DIVA), the Children's Fear Scale, and measurement of procedure duration using a stopwatch. Statistical analysis will be conducted using SPSS software with the support of a statistician.
The results of this study may contribute to improving the management of procedural fear in pediatric patients and may support the use of simple distraction techniques to improve procedural success and efficiency in pediatric emergency care.
- Being tested
- Musical-Moving Toy Distraction
- Keywords
- Peripheral Intravenous Catheterization, Difficult Intravenous Access, Pediatric Emergency, Distraction Technique, Children's Fear Scale, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical-Moving Toy DistractionOther
A musical-moving toy will be used as a distraction technique during peripheral intravenous catheterization. The toy will be presented to the child during the procedure to attract attention and reduce fear and distress associated with the catheterization process.
| Study group | Role | What they receive |
|---|---|---|
| Distraction With Musical-Moving Toy | Experimental | Children in this group will receive distraction using a musical-moving toy during peripheral intravenous catheterization. The toy will be used to attract the child's attention during the procedure in order to reduce fear and distress. Receives: Other: Musical-Moving Toy Distraction |
| Standard Care | No intervention | Children in the control group will receive standard care during peripheral intravenous catheterization without the use of the musical-moving toy distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear Level During IV Catheterization
Fear levels of children will be assessed during the IV catheterization procedure using the Children's Fear Scale. Scores range from 0 to 4, with higher scores indicating greater fear.
Measured: During the IV catheterization procedure (approximately 5 minutes)
Secondary outcomes (2)
Procedure Success
Procedure success will be evaluated based on whether peripheral intravenous catheterization is successfully completed and the number of attempts required.
Measured: During the intravenous catheterization procedure
Procedure Duration
Procedure duration will be measured using a stopwatch and defined as the time from the start of catheterization preparation until successful catheter placement.
Measured: During the intravenous catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start28 Nov 2024
- Primary completion24 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural Fear in ChildrenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group receiving distraction with a musical-moving toy during peripheral intravenous catheterization or a control group receiving standard care without the distraction intervention.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Kaya, Akdeniz University
- Investigators
- Okan Kumaş Kumaş, RN, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459517
- Sponsor's protocol ID
- TBAEK-151
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Jul 2026
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Musical-Moving Toy Used During Difficult Peripheral Intravenous Catheterization on Children's Fear Level and Procedure Success: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07459517
- Acronym / sponsor ID
- TBAEK-151
- Keywords
- Peripheral Intravenous Catheterization, Difficult Intravenous Access, Pediatric Emergency, Distraction Technique, Children's Fear Scale, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 9 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.
Peripheral intravenous catheterization (PIVC) is a frequently performed invasive procedure in pediatric emergency departments and is often associated with fear and distress in children. Children with difficult intravenous access (DIVA) may require multiple attempts for successful catheterization, which can increase fear, anxiety, and procedure time. Non-pharmacological distraction techniques are commonly used to reduce procedural distress in children.
This randomized controlled study aims to evaluate the effect of a musical-moving toy used as a distraction method during peripheral intravenous catheterization on children's fear levels, procedure success, and procedure duration. The study will be conducted in the pediatric emergency department of Antalya City Hospital in Türkiye.
Children aged 4-6 years with difficult intravenous access will be randomly assigned to either an intervention group or a control group. In the intervention group, a musical-moving toy will be used during the catheterization procedure to distract the child, while the control group will receive standard care without the toy.
Fear levels will be measured using the Children's Fear Scale. Procedure success will be evaluated by the number of attempts required to successfully insert the catheter, and procedure duration will be recorded using a stopwatch.
The findings of this study may contribute to improving pediatric procedural care by providing an effective, low-cost, and easily applicable distraction method during intravenous catheterization.
Detailed description
Peripheral intravenous catheterization (PIVC) is one of the most commonly performed invasive procedures in pediatric emergency departments for the administration of fluids, medications, and blood products. However, PIVC procedures can cause significant fear, anxiety, and distress in children. These negative experiences may lead to behavioral reactions such as crying, resistance, and refusal of treatment, which may complicate the procedure and increase procedure duration.
Children with difficult intravenous access (DIVA) represent a particularly challenging group, as multiple attempts may be required to successfully place a catheter. Previous research has shown that non-pharmacological distraction techniques can reduce pain, fear, and anxiety during invasive procedures in children. These techniques are inexpensive, easy to implement, and widely used in pediatric nursing practice.
Various distraction methods such as cartoons, balloon inflation, virtual reality, and distraction cards have been investigated in previous studies. However, limited evidence exists regarding the effectiveness of musical-moving toys as a distraction method during difficult intravenous catheterization procedures in young children.
This study is designed as a randomized controlled trial to evaluate the effect of a musical-moving toy used during PIVC procedures on children's fear level, procedure success, and procedure duration. The study will be conducted in the pediatric emergency department blood collection room of Antalya City Hospital.
A total of 68 children aged 4-6 years with a Difficult Intravenous Access Score (DIVA score) of 4 or higher will be included in the study. Participants will be randomly assigned to either an intervention group (n=34) or a control group (n=34) using simple randomization.
In the intervention group, a musical-moving toy will be used during the PIVC procedure to distract the child. The control group will receive standard care without the distraction intervention.
Data will be collected using a Child Information Form, the Difficult Intravenous Access Score (DIVA), the Children's Fear Scale, and measurement of procedure duration using a stopwatch. Statistical analysis will be conducted using SPSS software with the support of a statistician.
The results of this study may contribute to improving the management of procedural fear in pediatric patients and may support the use of simple distraction techniques to improve procedural success and efficiency in pediatric emergency care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group receiving distraction with a musical-moving toy during peripheral intravenous catheterization or a control group receiving standard care without the distraction intervention.
| Arm | Type | Receives |
|---|---|---|
| Distraction With Musical-Moving Toy | Experimental | Other: Musical-Moving Toy DistractionChildren in this group will receive distraction using a musical-moving toy during peripheral intravenous catheterization. The toy will be used to attract the child's attention during the procedure in order to reduce fear and distress. |
| Standard Care | No intervention | –Children in the control group will receive standard care during peripheral intravenous catheterization without the use of the musical-moving toy distraction intervention. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-6 years
- Children requiring peripheral intravenous catheterization in the pediatric emergency department
- Children with a Difficult Intravenous Access (DIVA) score ≥4
- Children whose parents or legal guardians provide informed consent for participation
Key exclusion criteria (4 listed)
- Children with cognitive or developmental disorders that may interfere with fear assessment
- Children with visual or hearing impairments preventing interaction with the distraction toy
- Children who require urgent or life-saving interventions
- Children whose parents decline participation in 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 |
|---|---|---|
| Musical-Moving Toy DistractionA musical-moving toy will be used as a distraction technique during peripheral intravenous catheterization. The toy will be presented to the child during the procedure to attract attention and reduce fear and distress associated with the catheterization process. | Other | Distraction With Musical-Moving Toy |
Primary outcome
Fear Level During IV Catheterization
Time frame: During the IV catheterization procedure (approximately 5 minutes)
Fear levels of children will be assessed during the IV catheterization procedure using the Children's Fear Scale. Scores range from 0 to 4, with higher scores indicating greater fear.
2 secondary outcomes
Procedure Success
Time frame: During the intravenous catheterization procedure
Procedure Duration
Time frame: During the intravenous catheterization procedure
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Okan Kumaş Kumaş, RN study chair
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical-Moving Toy Distraction in people with Procedural Fear in Children and Difficult Intravenous Access, 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 4 inclusion and 4 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 13 Jul 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?
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?
Fear Level During IV Catheterization (time frame: During the IV catheterization procedure (approximately 5 minutes)). 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 13 Jul 2026.