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Animated Video and Associated Pain and Anxiety Reduction, Following Pin Removal Post-supracondylar Fracture Fixation
NCT07234396 · Liaquat National Hospital & Medical College
In plain English
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Official title
Animated Procedure Video Reduces Pain and Anxiety Among Pediatric Patients Undergoing Pin Removal Following Supracondylar Fracture Fixation - A Randomized Controlled Trial
About this study
Supracondylar fractures requiring K-wire fixation ultimately undergo pin removal after fracture fixation. This is a cause of pain and anxiety to children. This study aims to curtail the aforementioned troubles by distracting the patient using an animated video of the procedure. Patients will be randomized into two arms, and pain and anxiety scales will be implemented before, during, and after the procedure to assess whether a change exists between the two arms.
Eligibility criteria
Inclusion Criteria:
* Patients with supracondylar fractures operated on for percutaneous K-wire fixation.
* Age between 4 to 12 years
Exclusion Criteria:
* Any syndromic patients
* Patients having any visual or cognitive disability
* Patients having any pre-operative or post-operative complications before pin removal.
* Patients undergoing the procedure under general anesthesia.
* Age \<4 or \>12
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2025-10-31
Estimated completion: 2026-01-20
Last updated: 2025-11-24
Interventions
Procedure: K-wire removal with animated procedure video being shown to the patient during its performance.Procedure: K-wire removal without animated procedure video being shown to the patient during its performance.
Primary outcomes
- • Wong Baker Pain scale (WBS) (Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.)
- • Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.)
- • Children's Anxiety Meter-State (CAM-S) (Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.)
Sponsor
Liaquat National Hospital & Medical College · other
Contacts & investigators
InvestigatorMohammad Nabeel Aamir Syed, MBBS, MD · principal_investigator
All locations (1)
Liaquat National HospitalRecruiting
Karachi, Sindh, Pakistan