NCT06959823

Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief

Evaluation of the Effect of the Integrated Innovative Bed Apparatus Developed for the Relief of Pain and Anxiety in Pediatric Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Bahçeşehir University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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-pharmacological interventions, especially those involving multisensory distraction, are increasingly used to alleviate distress. This study aimed to evaluate the effectiveness of a novel, child-friendly, multisensory support device in reducing pain and anxiety in pediatric surgical patients. Keywords: child, pain, anxiety, distraction, pediatrics, innovative device

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 procedure for the first time. Participants were randomly assigned to either the intervention (n=24) or control group (n=24) using block randomization based on age and sex. The intervention group received a Multisensory Pediatric Support Device that delivered combined audio (storybook narration), visual (lights), and animated stimuli during the procedure. The control group received standard preoperative and postoperative care. Pain and anxiety were measured using the Wong-Baker FACES Pain Rating Scale and the Children's Anxiety Meter State (CAM-S), respectively.

Conditions

• Pain Management
• Anxiety

Interventions

Type	Name	Description
DEVICE	Multisensory Pediatric Support Device (MSPSD)	Child-friendly multisensory device providing audio-visual distraction during invasive procedures.

Timeline

• Start date: 2024-04-02
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2025-05-07
• Last updated: 2025-05-07

Locations

1 site across 1 country: Turkey (Türkiye)