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Coronavirus (COVID-19)-related pause on all clinical research studies.
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| Name | Class |
|---|---|
| The Thomas Wilson Sanitarium for Children of Baltimore City | OTHER |
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This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.
Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.
As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.
The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Group (Study Group) | Experimental | In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure. |
|
| Active Control Group | No Intervention | In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure. | |
| External Control (Reference Group) | No Intervention | No virtual reality and no child life specialists; no standardized or formal form of support. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Other | A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Pain During the Procedure | Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. | Baseline and Immediately post-procedure, up to 15 minutes |
| Change in Patient-Reported Anxiety During Procedure | Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. | Baseline and Immediately post-procedure, up to 15 minutes |
| Change in Adult Perceived Pain During the Procedure | Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes |
| Change in Adult Perceived Anxiety During the Procedure | The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes |
| Change in Adult's Own Anxiety During the Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Procedure | Duration of procedure in minutes will be assessed for each procedure. | Immediately post-procedure, up to 20 minutes |
| Ease of Procedure as Assessed by a Likert Scale | Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult. |
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Inclusion Criteria:
Pediatric patients requiring painful or anxiety inducing procedures:
Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Therese Canares, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Children's Center | Baltimore | Maryland | 21212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34319249 | Derived | Canares T, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter K, McGuire J. Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. JMIR Pediatr Parent. 2021 Jul 28;4(3):e26040. doi: 10.2196/26040. | |
| 34127486 | Derived | Canares TL, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter KJ, McGuire JF. Resource Use During Pediatric Venipuncture With Virtual Reality: Secondary Analysis of a Randomized Controlled Pilot Trial. Hosp Pediatr. 2021 Jul;11(7):775-778. doi: 10.1542/hpeds.2020-003822. Epub 2021 Jun 14. |
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This study was conducted in the pediatric emergency department (PED) at an urban, tertiary care children's hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Group (Study Group) | In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality (VR): A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins. |
| FG001 | Standard Care (Control Group) | In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure. |
| FG002 | Reference Group | No virtual reality and no child life specialists; no standardized or formal form of support. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Group (Study Group) | In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-Reported Pain During the Procedure | Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. | Posted | Mean | Standard Deviation | Visual Analog scale range 0-10 | Baseline and Immediately post-procedure, up to 15 minutes |
|
Immediately post-procedure, up to 15minutes.
Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Group (Study Group) | In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Procedure Nausea | General disorders | Systematic Assessment | Patients with Post-Procedure Nausea Symptoms |
Early termination due to the COVID-19 pandemic, small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therese Canares | Johns Hopkins University | 4109964711 | tcanare1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2019 | Jun 2, 2020 | Prot_SAP_000.pdf |
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randomized, unblinded, controlled
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Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. |
| Baseline and Immediately post-procedure, up to 15 minutes |
| Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score | Coping was measured using a modified CAMPIS-SF in both patients and caregivers. CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0). | Immediately post-procedure, up to 15minutes |
| Immediately post-procedure, up to 15 minutes |
| Personnel Use for Immobilization | This will be assessed using number of patients requiring immobilization during procedures. | Immediately post-procedure, up to 15 minutes |
| Number of IV or Phlebotomy Attempts | Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures. | Immediately post-procedure, up to 15 minutes |
| Pre-Procedure Nausea Symptoms | The number of patients reporting nausea symptoms prior to the procedure | Immediately pre-procedure (15minutes) |
| Pre-Procedure Cybersickness Symptoms | Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure | Immediately pre-procedure (15minutes) |
| Standard Care (Control Group) |
In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure. |
| BG002 | Reference Group | No virtual reality and no child life specialists; no standardized or formal form of support. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Type of Procedure | Count of Participants | Participants |
|
| Child Baseline Pain Level | Pain described on visual analog scale or Wong-Faces Scale (with a score range of 0-10) with 0 being no pain and 10 being worst pain. | Mean | Standard Deviation | score on a scale |
|
| Child Baseline Anxiety Level | Anxiety described on visual analog scale (0-10), 0 being no anxiety and 10 being worst anxiety. | Mean | Standard Deviation | score on a scale |
|
| Adult Baseline Perceived Pain Level | Pain ratings were based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. This measure was assessed in caregivers. | Mean | Standard Deviation | score on a scale |
|
| Adult Baseline Perceived Anxiety Level | Anxiety ratings were based on a 0-10 Likert rating scale with 0 representing the least anxiety, and 10 representing the most. This measure was assessed in caregivers. | Mean | Standard Deviation | score on a scale |
|
| Adult Baseline Own Anxiety Level | Anxiety ratings were based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. This measure was assessed in caregivers. | Mean | Standard Deviation | score on a scale |
|
In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure. |
| OG002 | Reference Group | No virtual reality and no child life specialists; no standardized or formal form of support. |
|
|
| Primary | Change in Patient-Reported Anxiety During Procedure | Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. | Posted | Mean | Standard Deviation | Visual Analog scale range 0-10 | Baseline and Immediately post-procedure, up to 15 minutes |
|
|
|
| Primary | Change in Adult Perceived Pain During the Procedure | Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers. | Posted | Mean | Standard Deviation | Likert rating scale range 0-10 | Baseline and Immediately post-procedure, up to 15 minutes |
|
|
|
| Primary | Change in Adult Perceived Anxiety During the Procedure | The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Posted | Mean | Standard Deviation | Likert scale range 0-10 | Baseline and Immediately post-procedure, up to 15 minutes |
|
|
|
| Primary | Change in Adult's Own Anxiety During the Procedure | Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Posted | Mean | Standard Deviation | Likert scale range 0-10 | Baseline and Immediately post-procedure, up to 15 minutes |
|
|
|
| Primary | Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score | Coping was measured using a modified CAMPIS-SF in both patients and caregivers. CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0). | 13, 20 and 17 caregivers for the respective arms were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Proportion of total CAMPIS score | Immediately post-procedure, up to 15minutes |
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| Secondary | Duration of Procedure | Duration of procedure in minutes will be assessed for each procedure. | Posted | Mean | Standard Deviation | minutes | Immediately post-procedure, up to 20 minutes |
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| Secondary | Ease of Procedure as Assessed by a Likert Scale | Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult. | Posted | Mean | Standard Deviation | Likert scale range 0-10 | Immediately post-procedure, up to 15 minutes |
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| Secondary | Personnel Use for Immobilization | This will be assessed using number of patients requiring immobilization during procedures. | Posted | Count of Participants | Participants | Immediately post-procedure, up to 15 minutes |
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| Secondary | Number of IV or Phlebotomy Attempts | Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures. | This is a sub-analysis of the population undergoing venipuncture procedures only. 5 in the CL group and 2 in the VR group were excluded due to non-venipuncture procedures. 2 patients in the VR group were excluded due to a medical emergency and procedure cancellation. | Posted | Count of Participants | Participants | Immediately post-procedure, up to 15 minutes |
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| Secondary | Pre-Procedure Nausea Symptoms | The number of patients reporting nausea symptoms prior to the procedure | Posted | Count of Participants | Participants | Immediately pre-procedure (15minutes) |
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| Secondary | Pre-Procedure Cybersickness Symptoms | Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure | Included patients randomized to VR during the procedure | Posted | Count of Participants | Participants | Immediately pre-procedure (15minutes) |
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| 0 |
| 19 |
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | Standard Care (Control Group) | In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure. | 0 | 25 | 0 | 25 | 4 | 25 |
| EG002 | Reference Group | No virtual reality and no child life specialists; no standardized or formal form of support. | 0 | 20 | 0 | 20 | 4 | 20 |
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| Cybersickness Post-Procedure | General disorders | Systematic Assessment | Patients with Positive Cybersickness Symptoms Post-Procedure |
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| Child Distress Proportion |
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| Caregiver Coping Proportion |
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| Caregiver Distress Proportion |
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| Title | Measurements |
|---|---|
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