Pain, Postoperative, Scoliosis Idiopathic
Conditions
Keywords
Virtual reality, Distraction methods, Idiopathic scoliosis, Postoperative pain, Pediatric surgery
Brief summary
The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.
Detailed description
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.
Interventions
DEVICEApplied 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.
DEVICEApple iPad
The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subjects age 11 - 17 years of age * Patients undergoing idiopathic scoliosis surgery on Enhanced Recovery after Surgery (ERAS) spine protocol (which includes postoperative PCA)
Exclusion criteria
* Patient/caregiver refusal * Patients with developmental delay * Patients with seizure disorder * Non-English-speaking patients * Patients with daily opioid use \>/= two weeks * Patients with uncorrected visual or hearing impairment * Patients admitted to pediatric intensive care unit on postoperative day #1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Dose (in Milligram Morphine Equivalents) | From anesthesia end through hospital discharge, a total of approximately 2 days | 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. |
| Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30 | Recorded at end of intervention (T=30 minutes) | 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. |
| Pain Scores Via FLACC Scale by Research Assistant at Baseline | Recorded preoperatively as 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. |
| Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0 | Recorded immediately prior to intervention (T=0 minutes) | 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. |
| Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10 | Recorded at the 10 minute mark (T=10 minutes) | 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. |
| Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30 | Recorded at end of intervention (T=30 minutes) | 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. |
| Opioid PCA Use at T=-60-0 | Recorded for the hour prior to intervention (T=-60-0 minutes) | 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. |
| Opioid PCA Use at T=0-30 | Recorded during intervention (T=0-30 minutes) | 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. |
| Opioid PCA Use at T=30-90 | Recorded one hour after intervention is complete (T=30-90 minutes) | 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. |
| Pain Scores Via FACES Scale by Patient at Baseline | Recorded preoperatively as 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. |
| Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0 | Recorded immediately prior to intervention (T=0 min) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form | Recorded preoperatively as baseline | 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. |
| Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours | At approximately 48-72 hours postoperatively | 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. |
| Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days | At approximately 7-10 days postoperatively | 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. |
| Patient Satisfaction at 48-72 Hours | At approximately 48-72 hours postoperatively | 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. |
| Patient Satisfaction at 7-10 Days | At approximately 7-10 days postoperatively | 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. |
| Caregiver Satisfaction at 48-72 Hours | At approximately 48-72 hours postoperatively | 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. |
| Caregiver Satisfaction at 7-10 Days | At approximately 7-10 days postoperatively | 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. |
| Electronic Device Use | Assessed at time of intervention on postoperative day #1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Virtual Reality Device | iPad Device | Total |
|---|---|---|---|
| Age, Customized Aged 11-14 | 6 Participants | 7 Participants | 13 Participants |
| Age, Customized Aged 15-17 | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 12 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 0 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
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.
Time frame: Recorded during intervention (T=0-30 minutes)
Population: PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected.
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.
Time frame: Recorded one hour after intervention is complete (T=30-90 minutes)
Population: PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected.
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.
Time frame: Recorded for the hour prior to intervention (T=-60-0 minutes)
Population: PCA pumps were no longer in use by the time the study intervention was employed; therefore, these data were not collected.
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.
Time frame: Recorded preoperatively as baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality Device | Pain Scores Via FACES Scale by Patient at Baseline | 0.91 score on a scale |
| iPad Device | Pain Scores Via FACES Scale by Patient at Baseline | 0.92 score on a scale |
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.
Time frame: Recorded immediately prior to intervention (T=0 min)
Population: Data not included for participants who withdrew from study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality Device | Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0 | 5.00 score on a scale |
| iPad Device | Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0 | 4.22 score on a scale |
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.
Time frame: Recorded at end of intervention (T=30 minutes)
Population: Data not included for participants who withdrew from study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality Device | Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30 | 3.80 score on a scale |
| iPad Device | Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30 | 3.55 score on a scale |
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.
Time frame: Recorded preoperatively as baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Pain Scores Via FLACC Scale by Research Assistant at Baseline | 0 score on a scale | Standard Deviation 0 |
| iPad Device | Pain Scores Via FLACC Scale by Research Assistant at Baseline | 1.5 score on a scale | Standard Deviation 3.12 |
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.
Time frame: Recorded immediately prior to intervention (T=0 minutes)
Population: Data not included for participants who withdrew from study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0 | 0.60 score on a scale | Standard Deviation 1.07 |
| iPad Device | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0 | 0.33 score on a scale | Standard Deviation 0.71 |
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.
Time frame: Recorded at the 10 minute mark (T=10 minutes)
Population: Data not included for participants who withdrew from study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10 | 0 score on a scale | Standard Deviation 0 |
| iPad Device | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10 | 0.44 score on a scale | Standard Deviation 1.33 |
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.
Time frame: Recorded at end of intervention (T=30 minutes)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30 | 0 score on a scale | Standard Deviation 0 |
| iPad Device | Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30 | 0 score on a scale | Standard Deviation 0 |
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.
Time frame: From anesthesia end through hospital discharge, a total of approximately 2 days
Population: Data not included for participants who withdrew from study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Total Opioid Dose (in Milligram Morphine Equivalents) | 4.74 (mg) morphine equivalents | Standard Deviation 1.19 |
| iPad Device | Total Opioid Dose (in Milligram Morphine Equivalents) | 5.27 (mg) morphine equivalents | Standard Deviation 1.52 |
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.
Time frame: Recorded preoperatively as baseline
Population: Data were not collected for 1 participant in the iPad device group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form | 11.64 score on a scale | Standard Deviation 3.29 |
| iPad Device | Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form | 13.27 score on a scale | Standard Deviation 4.86 |
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.
Time frame: At approximately 48-72 hours postoperatively
Population: Due to COVID-19, all questionnaires were sent via email; however, no responses were received.
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.
Time frame: At approximately 7-10 days postoperatively
Population: Due to COVID-19, all questionnaires were sent via email; however, no responses were received.
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.
Time frame: Assessed at time of intervention on postoperative day #1
Population: Data not included for participants who withdrew from study and an additional 2 participants for whom data were inadvertently not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Device | Electronic Device Use | 20.33 minutes | Standard Deviation 7.58 |
| iPad Device | Electronic Device Use | 26.38 minutes | Standard Deviation 4.44 |
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.
Time frame: At approximately 48-72 hours postoperatively
Population: Due to COVID-19, all questionnaires were sent via email; however, no responses were received.
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.
Time frame: At approximately 7-10 days postoperatively
Population: Due to COVID-19, all questionnaires were sent via email; however, no responses were received.
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.
Time frame: At approximately 48-72 hours postoperatively
Population: Due to COVID-19, all questionnaires were sent via email; however, no responses were received.
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.
Time frame: At approximately 7-10 days postoperatively
Population: Due to COVID-19, all questionnaires were sent via email; however, no responses were received.