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NCT Number: NCT07234396

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

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.

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Key information

Conditions

Supracondylar Fractures Anxiety Anxiety Disorders Fracture Fixation Mental Disorders Neurologic Manifestations Pain Pain Severity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liaquat National Hospital

Karachi, Sindh, 74800, Pakistan

Location status: Recruiting

Location contact

Mohammad Nabeel Aamir Syed, MBBS, MD

PRINCIPAL_INVESTIGATOR

Mohammad Zeeshan Haider, MBBS, MRCS

CONTACT

[email protected]

+923432886821

Mohammad Zeeshan Haider, MBBS, MRCS

PRINCIPAL_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-wire removal with animated procedure video being shown to the patient during its performance.

Procedure

K-wire removal, post-supracondylar fracture fixation, will be performed while showing the patient an animated video of the procedure.

K-wire removal without animated procedure video being shown to the patient during its performance.

Procedure

K-wire removal, post-supracondylar fracture fixation, will be performed without showing the patient an animated video of the procedure.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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