Innovative Bed Apparatus for Pediatric Pain and Anxiety Relief
MSPSD
Evaluation of the Effect of the Integrated Innovative Bed Apparatus Developed for the Relief of Pain and Anxiety in Pediatric Patients
2 other identifiers
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedFirst Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedMay 7, 2025
April 1, 2025
5 months
April 28, 2025
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain Score Change
Assessed by Wong-Baker FACES Pain Rating Scale (min: 0, max: 10)
Before and immediately after invasive procedure.
Anxiety Score Change
Assessed by Children's Anxiety Meter State (CAM-S) (min: 0, max: 30)
Before and immediately after invasive procedure.
Study Arms (2)
MSPSD Intervention Group
EXPERIMENTALParticipants received multisensory pediatric support device (MSPSD) during invasive procedures.
Standard Care Group
NO INTERVENTIONParticipants received standard care without any multisensory device.
Interventions
Child-friendly multisensory device providing audio-visual distraction during invasive procedures.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 24108531BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assist. prof.
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 7, 2025
Study Start
April 2, 2024
Primary Completion
August 30, 2024
Study Completion
August 30, 2024
Last Updated
May 7, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- IPD and supporting documents will be available within 6 months after publication of the primary results and will remain available for 5 years thereafter.
- Access Criteria
- Access to the de-identified individual participant data will be granted to qualified researchers upon submission of a research proposal and approval by the principal investigator. A data use agreement is required prior to data sharing. Data will be transferred via secure electronic methods.
De-identified individual participant data (IPD) underlying the published results will be made available to qualified researchers upon reasonable request. Data requests should be directed to the principal investigator via email (dr.evinkorkmaz@gmail.com). Data will be shared after publication, with a data use agreement.