Supracondylar FracturesNCT07234396
Animated Video and Associated Pain and Anxiety Reduction, Following Pin Removal Post-supracondylar Fracture Fixation
A study testing K-wire removal with animated procedure video being shown to the patient during its performance. and K-wire removal without animated procedure video being shown to the patient during its performance. in people with Supracondylar Fractures and Fracture Fixation, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Supracondylar Fractures, Fracture Fixation, Pain Severity
- What is being tested?
- K-wire removal with animated procedure video being shown to the patient during its performance. and K-wire removal without animated procedure video being shown to the patient during its performance.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Oct 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with supracondylar fractures operated on for percutaneous K-wire fixation.
- Age between 4 to 12 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Liaquat National Hospital
Karachi, Sindh, 74800
Mohammad Zeeshan Haider, MBBS, MRCS, +923432886821, mohammadzh321@gmail.com
Mohammad Zeeshan Haider, MBBS, MRCS
About this study
Official title: 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.
Read the 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.
- Conditions
- Supracondylar Fractures, Fracture Fixation, Pain Severity, Anxiety
- Being tested
- K-wire removal with animated procedure video being shown to the patient during its performance., K-wire removal without animated procedure video being shown to the patient during its performance.
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-wire removal with animated procedure video being shown to the patient during its performance.Procedure or surgery
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 or surgery
K-wire removal, post-supracondylar fracture fixation, will be performed without showing the patient an animated video of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: K-wire removal without animated procedure video being shown to the patient during its performance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start31 Oct 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supracondylar FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Zeeshan Haider, Liaquat National Hospital & Medical College
- Investigators
- Mohammad Nabeel Aamir Syed, MBBS, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234396
- Sponsor's protocol ID
- RC-LNH-Orthopedics-10/2025/126
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animated Procedure Video Reduces Pain and Anxiety Among Pediatric Patients Undergoing Pin Removal Following Supracondylar Fracture Fixation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07234396
- Acronym / sponsor ID
- RC-LNH-Orthopedics-10/2025/126
- Conditions
- Supracondylar Fractures, Fracture Fixation, Pain Severity, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 whether a change exists between the two arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing pin removal being shown an animated video of the procedure. | Experimental | Procedure: K-wire removal with animated procedure video being shown to the patient during its performance.Patients undergoing K-wire removal after fixation of supracondylar fractures being shown an animated video of the procedure while it is performed. |
| Patients undergoing pin removal without being shown an animated video of the procedure. | Active comparator | Procedure: K-wire removal without animated procedure video being shown to the patient during its performance.Patients undergoing K-wire removal after fixation of supracondylar fractures without being shown an animated video of the procedure while it is performed. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with supracondylar fractures operated on for percutaneous K-wire fixation.
- Age between 4 to 12 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 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.K-wire removal, post-supracondylar fracture fixation, will be performed without showing the patient an animated video of the procedure. | Procedure or surgery | Patients undergoing pin removal without being shown an animated video of the procedure. |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Nabeel Aamir Syed, MBBS, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K-wire removal with animated procedure video being shown to the patient during its performance. and K-wire removal without animated procedure video being shown to the patient during its performance. in people with Supracondylar Fractures and Fracture Fixation, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.