IV Insertion in the Emergency Department Clinical Trial
Official title:
Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department: A Feasibility Pilot Study
| Verified date | October 2019 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department. Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting. In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion. The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction. If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | September 30, 2019 |
| Est. primary completion date | September 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 18 Years |
| Eligibility |
Inclusion criteria will be: 1. aged 8-17 years 2. able to speak and understand English 3. parent/guardian present 4. medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team) 5. requires IV insertion Exclusion criteria will be: 1. visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear 2. psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations) 3. skin, face or ear infections or injuries, which could contaminate the intervention equipment 4. medically unstable (CTAS 1; patient requires immediate IV insertion) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Pain Intensity | Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their pain and parents, nurses and the researcher will report children's pain BOTH prior to and following the procedure. | Baseline, 30 minutes after baseline | |
| Primary | Change in Child Distress | Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their distress and parents, nurses and the researcher will report children's distress BOTH prior to and following the procedure | Baseline, 30 minutes after baseline | |
| Primary | Change in Child Fear | Children will report fear BOTH prior to and following the procedure using the Child Fear Scale (CFS) which is a 5-face visual scale that measures fear intensity and is validated in children as young as 5 years. It consists of a 1-question scale rating fear from 0 - 4, based on the faces provided. A higher number represents higher fear intensity. | Baseline, 30 minutes after baseline | |
| Primary | Child Pain Catastrophizing | Children will report baseline tendencies to catastrophize about pain using the Pain Catastrophizing Scale - Child (PCS-C). This is a self-report measure of children's tendency to catastrophize about pain validated in children 8-18 years of age. 6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher pain catastrophizing. | Baseline | |
| Primary | Parent Pain Catastrophizing | Parents will report baseline tendencies to catastrophize about their child's pain using the Pain Catastrophizing Scale - Parent (PCS-P), which is a self-report measure of parents' tendency to catastrophize about their child's pain validated in parents of children 8-18 years of age. 6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher parental pain catastrophizing of their child's pain. | Baseline | |
| Primary | Parent Distress | Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire. This measure consists of 4-items responded to on an 11-point numeric rating scale from 0 ("not at all") to 10 ("extremely"). A higher number value represents higher distress levels. | 30 minutes after baseline measures are completed | |
| Primary | Child Presence Measure | This child self-report measure assesses effectiveness of the immersive aspect of the VR toolkit/iPad using 12 questions, a choice of three answers ("no", "a little", and "a lot"). | 30 minutes after baseline measures are completed | |
| Secondary | Recruitment log | Using an investigator-generated recruitment log, accrual rates will be measured by counting the number eligible children per recruitment day, participants enrolled, reasons for ineligibility, reasons for non-participation and reasons for study attrition. | through study completion, an average of 1 year | |
| Secondary | Acceptability | Measured using the VR Distraction Satisfaction Questionnaire completed by children, parents and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience. | 30 minutes after baseline measures are completed | |
| Secondary | Outcome measure feasibility | Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log. | through study completion, an average of 1 year | |
| Secondary | Technical Difficulties Log | Using an investigator-generated technical difficulties log, researchers will record data related to technical difficulties associated with the VR intervention, observed difficulties in implementing the trial protocol in the clinic and time to complete IV needle insertion. | through study completion, an average of 1 year |