Status:
COMPLETED
Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief
Lead Sponsor:
Bahçeşehir University
Conditions:
Pain Management
Anxiety
Eligibility:
All Genders
4-12 years
Phase:
NA
Brief Summary
Pain and anxiety are common responses in pediatric patients undergoing invasive procedures and can negatively affect both immediate care outcomes and future health-care experiences. Non-pharmacologica...
Detailed Description
This randomized controlled trial included 48 children aged 4-12 years who were hospitalized in the pediatric surgery unit of a tertiary hospital in Istanbul, Turkey, and who underwent an invasive proc...
Eligibility Criteria
Inclusion
- Children aged 4 to 12 years.
- Hospitalized in the pediatric surgery ward.
- Undergoing an invasive intervention (e.g., intravenous catheter insertion, intramuscular injection, wound care) for the first time during their hospital stay.
- Able to communicate and understand simple instructions.
- Written informed consent obtained from legal guardians and verbal assent from the child (as appropriate to developmental level).
Exclusion
- Children with cognitive impairments or developmental delays that prevent communication or reliable self-reporting.
- Children with previous experience of invasive procedures during the current hospitalization.
- Children receiving sedation or pharmacological anxiolytics before the procedure.
- Children or legal guardians who refuse to provide informed consent.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06959823
Start Date
April 2 2024
End Date
August 30 2024
Last Update
May 7 2025
Active Locations (1)
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1
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)