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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Musical Toy (Xylophone) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Before and within 5 minutes after the IV cannulation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During and within 5 minutes after the IV cannulation procedure |
| Parental Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trakya University Hospital | Edirne | 22020 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Due to the nature of the intervention, children, parents, and the nurse delivering the intervention could not be blinded. Outcome assessments (fear and pain) were conducted using video recordings evaluated by an independent researcher who was blinded to group assignment. All recordings were coded and anonymized. The statistician performing the analysis was also blinded, and group labels were masked (Group A and Group B) during statistical analysis to minimize detection and analytical bias.
|
| 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. |
|
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.
| Within 5-10 minutes after the procedure |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |