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Clinical Trial NCT07234396 for Supracondylar Fractures, Fracture Fixation, Pain Severity, Anxiety is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Animated Video and Associated Pain and Anxiety Reduction, Following Pin Removal Post-supracondylar Fracture Fixation 120 Pediatric
Clinical Trial NCT07234396 is an interventional study for Supracondylar Fractures, Fracture Fixation, Pain Severity, Anxiety that is recruiting. It started on October 31, 2025 with plans to enroll 120 participants. Led by Liaquat National Hospital & Medical College, it is expected to complete by January 20, 2026. The latest data from ClinicalTrials.gov was last updated on November 24, 2025.
Brief Summary
Assessing the reduction in pain and anxiety by the use of showing an animated video of the procedure, among pediatric patients undergoing pin removal after fixation of supracondylar fractures.
Detailed Description
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 ...Show More
Official Title
Animated Procedure Video Reduces Pain and Anxiety Among Pediatric Patients Undergoing Pin Removal Following Supracondylar Fracture Fixation - A Randomized Controlled Trial
Conditions
Supracondylar FracturesFracture FixationPain SeverityAnxietyOther Study IDs
- RC-LNH-Orthopedics-10/2025/126
NCT ID Number
Start Date (Actual)
2025-10-31
Last Update Posted
2025-11-24
Completion Date (Estimated)
2026-01-20
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPatients undergoing pin removal being shown an animated video of the procedure. Patients undergoing K-wire removal after fixation of supracondylar fractures being shown an animated video of the procedure while it is performed. | K-wire removal with animated procedure video being shown to the patient during its performance. K-wire removal, post-supracondylar fracture fixation, will be performed while showing the patient an animated video of the procedure. |
Active ComparatorPatients undergoing pin removal without being shown an animated video of the procedure. Patients undergoing K-wire removal after fixation of supracondylar fractures without being shown an animated video of the procedure while it is performed. | K-wire removal without animated procedure video being shown to the patient during its performance. K-wire removal, post-supracondylar fracture fixation, will be performed without showing the patient an animated video of the procedure. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Wong Baker Pain scale (WBS) | The Wong Baker Pain scale will be used to assess pain before, during, and after the procedure being performed. A self-assessment tool for pain that uses six cartoon faces to grade pain on a numerical range of 0-10 ranked in increasing order of pain. Higher scores depict worse outcome and increased pain. | 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) | Children's Hospital of Eastern Ontario Pain Scale will be used to assess pain before, during, and after the procedure being performed. A 10-item observational tool used to assess postoperative pain from a score of 4 to 13, higher scores indicating more pain and worse outcome. | 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) | The Children's Anxiety Meter-State scale will be used to assess anxiety before, during, and after the procedure being performed. This is a brief measure where scores are on a scale of 0-10; low scores depict better outcomes and high scores depict worse outcomes. | Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure. |
Short State Trait Anxiety Inventory Scale (STAI) | The Short State Inventory Scale will be used to assess anxiety before, during, and after the procedure being performed, using the questionnaire set by the scale itself. A 20-item self reported assessment tool which scores each item from 1 to 4 for a minimum score of 20 to a maximum of 80. Low scores mean less anxiety and better outcome and a high score means greater anxiety and worse outcome. Positively phrased items are reverse-scored to calculate the total score. | Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
4 Years
Eligible Sexes
All
- Patients with supracondylar fractures operated on for percutaneous K-wire fixation.
- Age between 4 to 12 years
- 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
Liaquat National Hospital & Medical CollegeStudy Responsible Party
Mohammad Zeeshan Haider, Principal Investigator, Resident Doctor, Liaquat National Hospital & Medical College
No contact data.
1 Study Locations in 1 Countries
Sindh
Liaquat National Hospital, Karachi, Sindh, 74800, Pakistan
Mohammad Zeeshan Haider, MBBS, MRCS, Contact, +923432886821, [email protected]
Mohammad Zeeshan Haider, MBBS, MRCS, Principal Investigator
Mohammad Nabeel Aamir Syed, MBBS, MD, Principal Investigator
Recruiting