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

NCT ID: NCT07234396

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-01-20

Brief Summary

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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

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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.

Conditions

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Supracondylar Fractures Fracture Fixation Pain Severity Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liaquat National Hospital & Medical College

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Zeeshan Haider

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad Nabeel Aamir Syed, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Liaquat National Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Facility Contacts

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Mohammad Zeeshan Haider, MBBS, MRCS

Role: primary

+923432886821

Other Identifiers

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RC-LNH-Orthopedics-10/2025/126

Identifier Type: -

Identifier Source: org_study_id

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