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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34AT011218 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology Based Intervention 1 (Phase 1) | Other |
| |
| Technology Based Intervention 1 (Phase 2) | Other |
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| Technology Based Intervention 2 (Phase 2) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology Based Intervention Group 1 | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Olbrecht, MD | Nemours Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Hospital | Wilmington | Delaware | 19803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38742940 | Derived | Orgil Z, Karthic A, Bell NF, Heisterberg LM, Williams SE, Ding L, Kashikar-Zuck S, King CD, Olbrecht VA. Use of Biofeedback-Based Virtual Reality in Pediatric Perioperative and Postoperative Settings: Observational Study. JMIR Perioper Med. 2024 Sep 16;7:e48959. doi: 10.2196/48959. | |
| 36697053 | Derived | Orgil Z, Johnson L, Karthic A, Williams SE, Ding L, Kashikar-Zuck S, King CD, Olbrecht VA. Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial. BMJ Open. 2023 Jan 25;13(1):e071274. doi: 10.1136/bmjopen-2022-071274. |
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IPD will not be shared with the public, but aggregate data will be publicly available upon request.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2026 | |
| Reset | Jun 24, 2026 |
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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 | Sep 8, 2022 | Feb 14, 2023 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2026 | Jun 24, 2026 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| Technology Based Intervention Group 2 | Device | 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. |
|
| 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) |
| D010335 | Pathologic Processes |