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

NCT07234396 | Recruiting DMC

• 1 other identifier: RC-LNH-Orthopedics-10/2025/126
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Fractures; Fracture Fixation; Pain Severity; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

Patients undergoing pin removal being shown an animated video of the procedure.

EXPERIMENTAL

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.

Patients undergoing pin removal without being shown an animated video of the procedure.

ACTIVE COMPARATOR

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.

Interventions

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.

Patients undergoing pin removal being shown 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.

Patients undergoing pin removal without being shown an animated video of the procedure.

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with supracondylar fractures operated on for percutaneous K-wire fixation.
• Age between 4 to 12 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Liaquat National Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Mohammad Nabeel Aamir Syed, MBBS, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 31, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 20, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)