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OpenTrials
Completed

NCT Number: NCT06959823

Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief

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

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multisensory Pediatric Support Device (MSPSD)

Device

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

Primary outcomes

  1. Pain Score Change

    Time frame: Before and immediately after invasive procedure.

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

  2. Anxiety Score Change

    Time frame: Before and immediately after invasive procedure.

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

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Acronym: MSPSD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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