Animated Video and Associated Pain and Anxiety Reduction, Following Pin Removal Post-supracondylar Fracture Fixation

November 19, 2025 updated by: Mohammad Zeeshan Haider, Liaquat National Hospital & Medical College

Animated Procedure Video Reduces Pain and Anxiety Among Pediatric Patients Undergoing Pin Removal Following Supracondylar Fracture Fixation - A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 whether a change exists between the two arms.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Liaquat National Hospital
        • Contact:
        • Principal Investigator:
          • Mohammad Zeeshan Haider, MBBS, MRCS
        • Principal Investigator:
          • Mohammad Nabeel Aamir Syed, MBBS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients 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.
Procedure: 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 Comparator: Patients 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong Baker Pain scale (WBS)
Time Frame: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
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)
Time Frame: 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 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)
Time Frame: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
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)
Time Frame: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat National Hospital & Medical College

Investigators

  • Principal Investigator: Mohammad Nabeel Aamir Syed, MBBS, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

January 20, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-LNH-Orthopedics-10/2025/126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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