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The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.
Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive distraction compared with standard electronic use postoperatively.
Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery After Surgery (ERAS) spine protocol at our institution.
Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, PCA use, etc. The intervention group will be offered a VR device for up to 30 minutes. The control group will be offered an iPad for up to 30 minutes. This visit will be performed twice on postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality device | Experimental | Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. |
|
| iPad device | Active Comparator | Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Applied VR | Device | The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores Via FACES Scale by Patient at Baseline | All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. | Recorded preoperatively as baseline |
| Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0 | All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively. | Recorded immediately prior to intervention (T=0 min) |
| Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30 | All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively. | Recorded at end of intervention (T=30 minutes) |
| Pain Scores Via FLACC Scale by Research Assistant at Baseline | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. | Recorded preoperatively as baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Electronic Device Use | VR device or iPad use in minutes. Minimal 0 minutes, maximum 60 minutes (30 minutes x 2 sessions). A higher number indicates more electronic device use, which is neither a better or worse outcome, but rather provides information about whether devices were used for the full allotted time or not. | Assessed at time of intervention on postoperative day #1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Specht, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina (UNC) Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29237632 | Background | Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934. | |
| 28893727 | Background | Eijlers R, Legerstee JS, Dierckx B, Staals LM, Berghmans J, van der Schroeff MP, Wijnen RM, Utens EM. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 11;6(9):e174. doi: 10.2196/resprot.7617. |
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Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to marley.lawrence@unchealth.unc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years.
Beginning 3 months and ending 5 years following publication
Researchers who present a methodologically sound proposal and return a signed data access agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Device | Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use. |
| FG001 | iPad Device | Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Device | Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Pain Scores Via FACES Scale by Patient at Baseline | All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. | Posted | Mean | Full Range | score on a scale | Recorded preoperatively as baseline |
|
During two 30-minute post-operative intervention visits, a total of approximately 1 hour.
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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 Device | Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Applied VR: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacob Nelson | University of North Carolina at Chapel Hill | 704-677-3801 | jacob14@live.unc.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 | May 17, 2020 | Jun 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Apple iPad | Device | The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications. |
|
| Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0 | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively. | Recorded immediately prior to intervention (T=0 minutes) |
| Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10 | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively. | Recorded at the 10 minute mark (T=10 minutes) |
| Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30 | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively. | Recorded at end of intervention (T=30 minutes) |
| Opioid PCA Use at T=-60-0 | Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome. | Recorded for the hour prior to intervention (T=-60-0 minutes) |
| Opioid PCA Use at T=0-30 | Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome. | Recorded during intervention (T=0-30 minutes) |
| Opioid PCA Use at T=30-90 | Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome. | Recorded one hour after intervention is complete (T=30-90 minutes) |
| Total Opioid Dose (in Milligram Morphine Equivalents) | The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability. | From anesthesia end through hospital discharge, a total of approximately 2 days |
| Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form | The State-Trait Anxiety Inventory (STAI) Short Form scoring tool is a self-report questionnaire. It contains 6 statements (i.e., 'I feel calm', with 1=Not at all, 2=Somewhat, 3=Moderately, 4=Very much). Scores range from 6-24, with 6 signifying no anxiety and 24 points signifying the highest level of anxiety. Higher score indicates a worse outcome. | Recorded preoperatively as baseline |
| Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours | A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome. | At approximately 48-72 hours postoperatively |
| Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days | A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome. | At approximately 7-10 days postoperatively |
| Patient Satisfaction at 48-72 Hours | To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | At approximately 48-72 hours postoperatively |
| Patient Satisfaction at 7-10 Days | To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | At approximately 7-10 days postoperatively |
| Caregiver Satisfaction at 48-72 Hours | To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | At approximately 48-72 hours postoperatively |
| Caregiver Satisfaction at 7-10 Days | To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | At approximately 7-10 days postoperatively |
| 29053848 | Background | Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129. |
| 29155488 | Background | Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20. |
| 28975600 | Background | Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4. |
| 25930099 | Background | Won AS, Tataru CA, Cojocaru CM, Krane EJ, Bailenson JN, Niswonger S, Golianu B. Two Virtual Reality Pilot Studies for the Treatment of Pediatric CRPS. Pain Med. 2015 Aug;16(8):1644-7. doi: 10.1111/pme.12755. Epub 2015 Apr 30. No abstract available. |
| BG001 | iPad Device | Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications. |
| BG002 | 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 |
|
| OG001 |
| iPad Device |
Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications. |
|
|
| Primary | Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0 | All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively. | Data not included for participants who withdrew from study | Posted | Mean | Full Range | score on a scale | Recorded immediately prior to intervention (T=0 min) |
|
|
|
| Primary | Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30 | All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively. | Data not included for participants who withdrew from study. | Posted | Mean | Full Range | score on a scale | Recorded at end of intervention (T=30 minutes) |
|
|
|
| Primary | Pain Scores Via FLACC Scale by Research Assistant at Baseline | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Recorded preoperatively as baseline |
|
|
|
| Primary | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0 | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively. | Data not included for participants who withdrew from study. | Posted | Mean | Standard Deviation | score on a scale | Recorded immediately prior to intervention (T=0 minutes) |
|
|
|
| Primary | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10 | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively. | Data not included for participants who withdrew from study. | Posted | Mean | Standard Deviation | score on a scale | Recorded at the 10 minute mark (T=10 minutes) |
|
|
|
| Primary | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30 | The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively. | Data not included for participants who withdrew from study. Data are included for those participants who interacted with the intervention for the full 30-minute time limit. | Posted | Mean | Standard Deviation | score on a scale | Recorded at end of intervention (T=30 minutes) |
|
|
|
| Primary | Opioid PCA Use at T=-60-0 | Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome. | PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected. | Posted | Recorded for the hour prior to intervention (T=-60-0 minutes) |
|
|
| Primary | Opioid PCA Use at T=0-30 | Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome. | PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected. | Posted | Recorded during intervention (T=0-30 minutes) |
|
|
| Primary | Opioid PCA Use at T=30-90 | Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome. | PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected. | Posted | Recorded one hour after intervention is complete (T=30-90 minutes) |
|
|
| Primary | Total Opioid Dose (in Milligram Morphine Equivalents) | The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability. | Data not included for participants who withdrew from study. | Posted | Mean | Standard Deviation | (mg) morphine equivalents | From anesthesia end through hospital discharge, a total of approximately 2 days |
|
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|
| Secondary | Electronic Device Use | VR device or iPad use in minutes. Minimal 0 minutes, maximum 60 minutes (30 minutes x 2 sessions). A higher number indicates more electronic device use, which is neither a better or worse outcome, but rather provides information about whether devices were used for the full allotted time or not. | Data not included for participants who withdrew from study and an additional 2 participants for whom data were inadvertently not recorded. | Posted | Mean | Standard Deviation | minutes | Assessed at time of intervention on postoperative day #1 |
|
|
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| Secondary | Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form | The State-Trait Anxiety Inventory (STAI) Short Form scoring tool is a self-report questionnaire. It contains 6 statements (i.e., 'I feel calm', with 1=Not at all, 2=Somewhat, 3=Moderately, 4=Very much). Scores range from 6-24, with 6 signifying no anxiety and 24 points signifying the highest level of anxiety. Higher score indicates a worse outcome. | Data were not collected for 1 participant in the iPad device group. | Posted | Mean | Standard Deviation | score on a scale | Recorded preoperatively as baseline |
|
|
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| Secondary | Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours | A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome. | Due to COVID-19, all questionnaires were sent via email; however, no responses were received. | Posted | At approximately 48-72 hours postoperatively |
|
|
| Secondary | Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days | A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome. | Due to COVID-19, all questionnaires were sent via email; however, no responses were received. | Posted | At approximately 7-10 days postoperatively |
|
|
| Secondary | Patient Satisfaction at 48-72 Hours | To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | Due to COVID-19, all questionnaires were sent via email; however, no responses were received. | Posted | At approximately 48-72 hours postoperatively |
|
|
| Secondary | Patient Satisfaction at 7-10 Days | To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | Due to COVID-19, all questionnaires were sent via email; however, no responses were received. | Posted | At approximately 7-10 days postoperatively |
|
|
| Secondary | Caregiver Satisfaction at 48-72 Hours | To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | Due to COVID-19, all questionnaires were sent via email; however, no responses were received. | Posted | At approximately 48-72 hours postoperatively |
|
|
| Secondary | Caregiver Satisfaction at 7-10 Days | To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified. | Due to COVID-19, all questionnaires were sent via email; however, no responses were received. | Posted | At approximately 7-10 days postoperatively |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | iPad Device | Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Apple iPad: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |