Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief

Not Applicable

Completed

• Conditions: Pain Management; Anxiety

• Registration Number: NCT06959823
• Lead Sponsor: Bahçeşehir University

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-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.

Study Timeline

• Study Start: 2024-04-02
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Score Change	Before and immediately after invasive procedure.	Assessed by Wong-Baker FACES Pain Rating Scale (min: 0, max: 10)
Anxiety Score Change	Before and immediately after invasive procedure.	Assessed by Children's Anxiety Meter State (CAM-S) (min: 0, max: 30)

Trial Locations

Locations (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital; 🇹🇷 Istanbul, Turkey