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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorLiaquat National Hospital & Medical College

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with supracondylar fractures operated on for percutaneous K-wire fixation.

Age between 4 to 12 years

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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/Surgery

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Patients undergoing pin removal being shown an animated video of the procedure.Experimental treatment 1 intervention
Group B: Patients undergoing pin removal without being shown an animated video of the procedure.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
2

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.

Time frame
Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
3

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.

Time frame
Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
4

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.

Time frame
Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.

Secondary outcomes

Other outcomes

Sponsors and contacts

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