Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Feasibility and Acceptability of a Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain in Children and Adolescents After Surgery

To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain; Pain, Postoperative; Surgery; Pain, Acute
• Intervention / Treatment: Device: Technology Based Intervention Group 2; Device: Technology Based Intervention Group 1

Detailed Description

This is a 2-phase study aimed to refine a perioperative treatment protocol for a technology-based intervention (Aim 1) and to understand whether technology-based interventions can be used to help treat pain in children following surgery (Aim 2). Patients will participate in only one phase of the study, and when patients are enrolled will determine what Phase of the study they are in.

In Phase 1, all patients will use the same technology, and no randomization will occur. Primary and secondary outcome measures of Aim 1 are assessed in Phase 1. Actual enrollment for Phase 1 was 23 patients.

In Phase 2, patients will be randomized to receive 1 of 2 technology-based interventions. The perioperative treatment protocol developed in Phase 1 (Aim 1) will be used in Phase 2 to assess the primary and secondary outcome measures of Aim 2. This phase is anticipated to enroll up to 70 participants.

This is not an FDA-regulated drug or device trial as the technology used in this study is categorized as a relaxation device by the FDA and considered "minimal risk", thus exempt from both NDE and IDE.

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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
• Able to read, understand and speak English
• Patients requiring management by the Acute Pain Service
• Possession of a mobile device/computer available for study participation

Exclusion Criteria:

• Outside the age range (< 12 or > 18 years)
• Non-English speaking
• 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)
• History of vertigo, dizziness, seizure disorder, and/or severe motion sickness
• History of chronic pain
• Are chronically using opioids and or benzodiazepines for the management of pain
• Are actively experiencing nausea or vomiting
• Conditions such as craniofacial abnormalities or surgeries of the head and neck
• Previous participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Technology Based Intervention 1 (Phase 1)	Device: Technology Based Intervention Group 1; In Phase 1, all participants will use the same technology. In Phase 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.
Other: Technology Based Intervention 1 (Phase 2)	Device: Technology Based Intervention Group 1; In Phase 1, all participants will use the same technology. In Phase 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.
Other: Technology Based Intervention 2 (Phase 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1: Treatment protocol refinement	Frequency of sessions	Duration of study up to 30 days
Aim 1: Treatment protocol refinement	Duration of sessions	Duration of study up to 30 days
Aim 2: Feasibility of technology intervention in perioperative patients	Rate of study recruitment	Pre-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1: Preoperative training protocol	Frequency of preoperative training session	Up to two weeks pre-operatively
Aim 1: Preoperative training protocol	Duration of preoperative training session	Up to two weeks pre-operatively
Aim 1: Post-operative session protocol	Frequency of post-operative intervention session	Up to two week post surgery
Aim 1: Post-operative session protocol	Duration of post-operative intervention session	Up to two weeks post surgery
Aim 2: Rate of study enrollment/randomization	Assessment of ability to enroll and randomize patients in pilot clinical trial	Pre-intervention
Aim 2: Rate of study retention	Assessment of ability to retain patients in pilot clinical trial	Duration of study up to 30 days
Aim 2: Rate of treatment adherence	Assessment of patient adherence to study protocol	Duration of study up to 30 days
Aim 2: Treatment-specific satisfaction	Qualitative feedback from participants using questionnaire to assess intervention satisfaction	Post intervention up to two weeks
Aim 2: Treatment-specific satisfaction	Qualitative feedback from participants using semi-structured interview to assess intervention satisfaction	Post intervention up to two weeks
Aim 2: Effect of technology on anxiety	Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.	30 minutes after using technology
Aim 2: Effect of technology on medication use	Medications used will be collected	Duration of hospital stay (2-7 days)
Aim 2: Effect of technology on anxiety	Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.	Before using technology
Aim 2: Effect of technology on anxiety	Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.	Immediately after using technology
Aim 2: Effect of technology on pain	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.	Preoperatively (up to 5 days)
Aim 2: Effect of technology on pain	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.	Before using technology
Aim 2: Effect of technology on pain	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.	Immediately after using technology
Aim 2: Effect of technology on pain	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.	30 minutes after using technology
Aim 2: Self-Reported Outcomes	Semi-structured interview	Day of hospital discharge (Postoperatively 2-7 days)

Collaborators and Investigators

• Sponsor: Vanessa Olbrecht
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Vanessa Olbrecht, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: 2020-0994; 5R34AT011218 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with the public, but aggregate data will be publicly available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No