Pain ManagementNCT06938776
Interactive Musical Toy Reduces Pain and Fear During IV Cannulation in Preschool Children
A study testing Musical Toy (Xylophone) in people with Pain Management, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effects of using a musical toy (xylophone) as a distraction technique during peripheral intravenous cannulation on pain, fear, and parental satisfaction in hospitalized children aged 3 to 6 years. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Musical Toy (Xylophone)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3 and 6 years
- Hospitalized and scheduled for peripheral intravenous cannulation
- No hearing or mental disabilities
- No chronic disease associated with pain
- No analgesic use in the past 6 hours
- One parent present during the procedure
Show all 9Show fewer
- Both child and parent voluntarily agree to participate
- Intravenous cannulation to be performed in a single attempt
- Parent/guardian is literate
Who cannot join
- Children with hearing impairment or mental disabilities
- Use of analgesics within the last 6 hours
- Presence of chronic pain conditions
- Parental refusal to participate
- Failed intravenous cannulation attempt
- Illiterate parent/guardian
- Any parental mental disability
- Child or parent unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Musical Toy on Pain, Fear, and Parental Satisfaction During IV Cannulation in Hospitalized Children
This randomized controlled trial investigates the effects of using a musical toy (xylophone) as a distraction technique during peripheral intravenous cannulation on pain, fear, and parental satisfaction in hospitalized children aged 3 to 6 years. The study will be conducted in the Pediatric Health and Diseases Clinic of Trakya University in Edirne, Turkey.
A total of 64 children will be randomly assigned to either the intervention group or the control group. Children in the intervention group will be encouraged to play with a xylophone, accompanied by a nurse, before and during the cannulation procedure. The control group will receive standard care without any distraction. Pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, fear will be assessed using the Children's Fear Scale, and parental satisfaction will be evaluated using the PedsQL Healthcare Satisfaction Scale.
Read more
The primary objective of this randomized controlled trial is to evaluate whether the use of a musical toy during peripheral intravenous cannulation reduces procedural fear in preschool children.
Secondary objectives are to determine whether the intervention reduces procedural pain and improves parental satisfaction with the healthcare experience
This study is expected to contribute to the evidence base supporting the use of non-pharmacological methods in pediatric pain management and to promote child-friendly approaches in clinical settings.
- Conditions
- Pain Management
- Being tested
- Musical Toy (Xylophone), Standard Care (in control arm)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical Toy (Xylophone)Behavioural
Children in this group will play with a colorful xylophone toy for 5 minutes before and during peripheral intravenous cannulation. A nurse (researcher) will assist the child in playing with the toy to distract them from the procedure. The toy will be cleaned between uses. This non-pharmacological method aims to reduce pain and fear.
Standard Care (in control arm)Other
Children in this group will receive routine peripheral intravenous cannulation according to standard hospital protocols. No distraction or behavioral intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Musical Toy (Xylophone) Group | Experimental | Children in this group will play with a colorful xylophone toy accompanied by a nurse before and during peripheral intravenous cannulation. The distraction is intended to reduce procedural pain and fear. Receives: Behavioral: Musical Toy (Xylophone) |
| Arm 2: Control Group | Other | Children in this group will undergo the standard IV insertion procedure with no distraction technique. Standard hospital protocol will be followed. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2. Fear Level
Fear levels will be assessed using the Children's Fear Scale (CFS), which ranges from 0 (no fear) to 4 (extreme fear).
Measured: Before and within 5 minutes after the IV cannulation procedure
Secondary outcomes (2)
Pain Level
Children's pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 5 (worst pain).
Measured: During and within 5 minutes after the IV cannulation procedure
Parental Satisfaction
Parental satisfaction regarding their child's IV experience will be evaluated using the PedsQL Healthcare Satisfaction Scale. Scores range from 0 to 100, with higher scores indicating greater satisfaction.
Measured: Within 5-10 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start15 May 2025
- Primary completion15 Oct 2025
- Study completion15 Dec 2025
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Kocaaslan Mutlu, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938776
- Sponsor's protocol ID
- TUTF-SBF-ENK-05
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2025
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Musical Toy on Pain, Fear, and Parental Satisfaction During IV Cannulation in Hospitalized Children
- ClinicalTrials.gov ID
- NCT06938776
- Acronym / sponsor ID
- TUTF-SBF-ENK-05
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 22 Apr 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 using a musical toy (xylophone) as a distraction technique during peripheral intravenous cannulation on pain, fear, and parental satisfaction in hospitalized children aged 3 to 6 years. The study will be conducted in the Pediatric Health and Diseases Clinic of Trakya University in Edirne, Turkey.
A total of 64 children will be randomly assigned to either the intervention group or the control group. Children in the intervention group will be encouraged to play with a xylophone, accompanied by a nurse, before and during the cannulation procedure. The control group will receive standard care without any distraction. Pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, fear will be assessed using the Children's Fear Scale, and parental satisfaction will be evaluated using the PedsQL Healthcare Satisfaction Scale.
The primary objective of this randomized controlled trial is to evaluate whether the use of a musical toy during peripheral intravenous cannulation reduces procedural fear in preschool children.
Secondary objectives are to determine whether the intervention reduces procedural pain and improves parental satisfaction with the healthcare experience
This study is expected to contribute to the evidence base supporting the use of non-pharmacological methods in pediatric pain management and to promote child-friendly approaches in clinical settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Musical Toy (Xylophone) Group | Experimental | Behavioral: Musical Toy (Xylophone)Children in this group will play with a colorful xylophone toy accompanied by a nurse before and during peripheral intravenous cannulation. The distraction is intended to reduce procedural pain and fear. |
| Arm 2: Control Group | Other | Other: Standard Care (in control arm)Children in this group will undergo the standard IV insertion procedure with no distraction technique. Standard hospital protocol will be followed. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 3 and 6 years
- Hospitalized and scheduled for peripheral intravenous cannulation
- No hearing or mental disabilities
- No chronic disease associated with pain
- No analgesic use in the past 6 hours
Key exclusion criteria (8 listed)
- Children with hearing impairment or mental disabilities
- Use of analgesics within the last 6 hours
- Presence of chronic pain conditions
- Parental refusal to participate
- Failed intravenous cannulation attempt
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 Toy (Xylophone)Children in this group will play with a colorful xylophone toy for 5 minutes before and during peripheral intravenous cannulation. A nurse (researcher) will assist the child in playing with the toy to distract them from the procedure. The toy will be cleaned between uses. This non-pharmacological method aims to reduce pain and fear. | Behavioural | Arm 1: Musical Toy (Xylophone) Group |
| Standard Care (in control arm)Children in this group will receive routine peripheral intravenous cannulation according to standard hospital protocols. No distraction or behavioral intervention will be applied. | Other | Arm 2: Control Group |
Primary outcome
2. Fear Level
Time frame: Before and within 5 minutes after the IV cannulation procedure
Fear levels will be assessed using the Children's Fear Scale (CFS), which ranges from 0 (no fear) to 4 (extreme fear).
2 secondary outcomes
Pain Level
Time frame: During and within 5 minutes after the IV cannulation procedure
Parental Satisfaction
Time frame: Within 5-10 minutes after the 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 23 Mar 2026.
- 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 Musical Toy (Xylophone) in people with Pain Management, run by Trakya 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 9 inclusion and 8 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 23 Mar 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?
2. Fear Level (time frame: Before and within 5 minutes after the IV cannulation procedure). 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 23 Mar 2026.