Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
Study Details
Study Description
Brief Summary
To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Technology Based Intervention 1
|
Device: Technology Based Intervention Group 1
Participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.
|
| Other: Technology Based Intervention 2
|
Device: Technology Based Intervention Group 2
Participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.
|
Outcome Measures
Primary Outcome Measures
- Aim 1: Treatment protocol refinement [Duration of study up to 30 days]
Frequency of sessions
- Aim 1: Treatment protocol refinement [Duration of study up to 30 days]
Duration of sessions
- Aim 2: Feasibility of technology intervention in perioperative patients [Pre-intervention]
Rate of study recruitment
Secondary Outcome Measures
- Aim 1: Preoperative training protocol [Up to two weeks pre-operatively]
Frequency of preoperative training session
- Aim 1: Preoperative training protocol [Up to two weeks pre-operatively]
Duration of preoperative training session
- Aim 1: Post-operative session protocol [Up to two week post surgery]
Frequency of post-operative intervention session
- Aim 1: Post-operative session protocol [Up to two weeks post surgery]
Duration of post-operative intervention session
- Aim 2: Rate of study enrollment/randomization [Pre-intervention]
Assessment of ability to enroll and randomize patients in pilot clinical trial
- Aim 2: Rate of study retention [Duration of study up to 30 days]
Assessment of ability to retain patients in pilot clinical trial
- Aim 2: Rate of treatment adherence [Duration of study up to 30 days]
Assessment of patient adherence to study protocol
- Aim 2: Treatment-specific satisfaction [Post intervention up to two weeks]
Qualitative feedback from participants using questionnaire to assess intervention satisfaction
- Aim 2: Treatment-specific satisfaction [Post intervention up to two weeks]
Qualitative feedback from participants using semi-structured interview to assess intervention satisfaction
- Aim 2: Effect of technology on anxiety [30 minutes after using technology]
Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
- Aim 2: Effect of technology on medication use [Duration of hospital stay (48 - 96 hours)]
Medications used will be collected
- Aim 2: Effect of technology on anxiety [Before using technology]
Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
- Aim 2: Effect of technology on anxiety [Immediately after using technology]
Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
- Aim 2: Effect of technology on pain [Preoperatively (up to 168 hours)]
Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
- Aim 2: Effect of technology on pain [Before using technology]
Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
- Aim 2: Effect of technology on pain [Immediately after using technology]
Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
- Aim 2: Effect of technology on pain [30 minutes after using technology]
Pains scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
- Aim 2: Self-Reported Outcomes [Day of hospital discharge (Postoperatively 48-96 hours)]
Semi-structured interview
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ages 12 -18 years
-
Scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay > or = to 2 days
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Able to read, understand and speak English
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Patients requiring management by the Acute Pain Service
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Possession of a mobile device/computer available for study participation
Exclusion Criteria:
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Outside the age range (< 12 or > 18 years)
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Non-English speaking
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History of significant developmental delay, uncontrolled psychiatric conditions associated with hallucinations or delusions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
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History of vertigo, dizziness, seizure disorder, and/or severe motion sickness
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History of chronic pain
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Are currently using opioids and or benzodiazepines for the management of pain
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Are actively experiencing nausea or vomiting
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Conditions that would preclude the application of the VR headset, such as craniofacial abnormalities or surgeries of the head and neck
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Previous participation in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
Sponsors and Collaborators
- Vanessa Olbrecht
Investigators
- Principal Investigator: Vanessa Olbrecht, MD, Nationwide Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-0994