Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2024-08-30

Brief Summary

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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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Detailed Description

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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

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Pain Management Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MSPSD Intervention Group

Participants received multisensory pediatric support device (MSPSD) during invasive procedures.

Group Type EXPERIMENTAL

Multisensory Pediatric Support Device (MSPSD)

Intervention Type DEVICE

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

Standard Care Group

Participants received standard care without any multisensory device.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multisensory Pediatric Support Device (MSPSD)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No