Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief

Bahçeşehir University48 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pain Management Anxiety

Interventions

Multisensory Pediatric Support Device (MSPSD)DEVICE

Child-friendly multisensory device providing audio-visual distraction during invasive procedures.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Pain Score Change

Assessed by Wong-Baker FACES Pain Rating Scale (min: 0, max: 10)

Time frame: Before and immediately after invasive procedure.

Anxiety Score Change

Assessed by Children's Anxiety Meter State (CAM-S) (min: 0, max: 30)

Time frame: Before and immediately after invasive procedure.

Data from ClinicalTrials.gov

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