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Completed

NCT Number: NCT03784352

Virtual Reality Pediatric Orthopaedic Outpatient Procedures

The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing pain and anxiety levels during common pediatric orthopaedic outpatient procedures which include: cast application, cast removal, hardware removal (ie. pins and screws), and botox injections.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Children's Hospital

Vancouver, Ontario, V6H3N1, Canada

About this study

Immediately following recruitment, demographic data and diseased related information (ie. location of cast/hardware, reason for cast/hardware placement and location and reason for botox injection) will be collected through self and/or guardian report. All data will be collected using REDCap (research electronic data capture). Using a parallel group design, patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure classifications (hardware or cast or staple or suture removal or cast application or botox injection) site of hardware or cast or staple or suture or botox injection), and reason for the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI) is completed by the patient to collect pre-procedural state anxiety measurements. Following this, patients in the control group will receive standard of care (SOC) which allows for the technician and/or accompanying guardian to try and distract and or console the patient as they normally would. The patients in the intervention group will receive SOC with Virtual Reality (VR) interaction a few minutes before, during and following the procedure (around 5-10minutes total). During the procedure the researcher will complete an observational survey (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure and their current pain levels post procedure while parent/guardians and cast technician will be asked to complete their respective satisfaction questionnaires. Following this, the child will be asked if they experienced any nausea at any point during the procedure, if they did, they will be asked to complete the BARF questionnaire to measure the amount of nausea experienced. Following completion of questionnaires, patients who were in the control group are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to incentivize recruitment for the study.

SOC will consist of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • child must be between the ages of 4 and 18 years
  • the parent/guardians and child are both able to speak and read English or have a translator be present for them

Exclusion criteria

  • symptoms of respiratory or gastrointestinal infection
  • visual, auditory, cognitive impairment or developmental delay
  • history of seizures or epilepsy

Treatment and study plan

Virtual reality

Device

A calming virtual reality game will be played

Primary outcomes

  1. Wong Baker Scale (WBS) for Procedural Pain

    Time frame: Immediately post procedure

    The WBS is a self-reported outcome measure that asks patients to rate their pain severity by circling the face that best describes the pain on a horizontally positioned VAS with marked end points of "no pain" and "worst possible pain". There are six possible faces with "no pain" representing a score of 0 and "worst pain" representing a score of 10

  2. Anxiety (state anxiety intraprocedure)

    Time frame: Intraprocedure

    Intraprocedural state anxiety will be measured using the The Children's Emotional Manifestation Scale (CEMS) which consists of five categories that include:

    Facial expression, vocalization, activity, interaction and level of cooperation. A score is obtained by reviewing five descriptions in each category and selecting the number that most clearly represents the observed behavior. Each category is given a score from 1 to 5 for a total score of 5-25. A higher score corresponds to a more distressed child.

Secondary outcomes

  1. Procedural Time

    Time frame: Intraprocedure

    Measured with a stopwatch: Start of the procedure defined as the moment the patient completes the first short SAIS, which is shortly upon entering the procedural room. End of the procedure is marked as follows: complete removal of cast (for cast removal), removal of last staple or hardware (staple and hardware removal), removal of needle from final injection site (botox injection)

  2. Baxter Retching Faces (BARF) Scale for Nausea

    Time frame: Immediately post procedure

    Patients will use the pictorial Baxter Retching Faces Scale (BARF) to measure nausea severity. It is a scale of 0-10 with 6 faces, with the first representing no nausea to the last as experiencing vomiting. This scale has been shown to have construct, content and convergent validity in measuring nausea in children. After the patients have completed the post procedure short SAIS the patients will be asked if they had experienced any feelings of nausea at any point during the procedure. If they answer yes, then they will be asked to rate the nausea using the BARF scale.

  3. State Anxiety Preprocedure

    Time frame: Immediately pre-procedure

    State Anxiety will be measured prior to start of procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.

  4. State Anxiety Postprocedure

    Time frame: Immediately post procedure

    State Anxiety will also be measured immediately after completion of the procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.

  5. Trait Anxiety

    Time frame: Preprocedure while in the waiting area

    The Penn State Worry Questionnaire for Children (PSWQ-C) is a screening tool for assessing generalized anxiety in children aged 7-17 years. It consists of a 14 item self-reported questionnaire. Respondents indicate how often each item applies to them, choosing from the following responses: "never", "sometimes", "often", and "always", with points ranging from 0 to 3 for each item. The total score ranges from 0 to 42, with higher scores indicating a greater tendency to worry. The total time to complete the questionnaire is approximately five minutes.

Sponsors and collaborators

Lead sponsor

British Columbia Children's Hospital

Other

Registry information

Official study title

Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial

Acronym: VPRO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Mar 2, 2020

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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