Clinical trial NCT06959823: Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief
Official title: Evaluation of the Effect of the Integrated Innovative Bed Apparatus Developed for the Relief of Pain and Anxiety in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Anxiety
Keywords: child
pain
anxiety
distraction
innovative device
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Score Change
timeFrame: Before and immediately after invasive procedure.
measure: Anxiety Score Change
timeFrame: Before and immediately after invasive procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Study officials:
References:
citation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.