PainNCT04943874
Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
A study testing Technology Based Intervention Group 1 and Technology Based Intervention Group 2 in people with Pain and Pain, Postoperative, run by Vanessa Olbrecht at 1 site in United States.
Trial summary
To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pain, Pain, Postoperative, Pain, Acute
- What is being tested?
- Technology Based Intervention Group 1 and Technology Based Intervention Group 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 22 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Are actively experiencing nausea or vomiting
- Conditions such as craniofacial abnormalities or surgeries of the head and neck
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Hospital
Wilmington, Delaware, 19803
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Pain, Postoperative, Pain, Acute, Surgery
- Being tested
- Technology Based Intervention Group 1, Technology Based Intervention Group 2
- Medical subject headings
- Pain, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Based Intervention Group 1Device
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.
Technology Based Intervention Group 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Technology Based Intervention 1 (Phase 1) | Other | Not described Receives: Device: Technology Based Intervention Group 1 |
| Technology Based Intervention 1 (Phase 2) | Other | Not described Receives: Device: Technology Based Intervention Group 1 |
| Technology Based Intervention 2 (Phase 2) | Other | Not described Receives: Device: Technology Based Intervention Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 (Phase 1): Treatment Protocol Refinement
The goal of Aim 1 (Phase 1) of this study was to refine a study (treatment) protocol for the application of the VR technology in children and adolescents undergoing surgery anticipated to cause moderate to severe pain. The study protocol developed in Phase 1 would then be used as the study protocol to assess feasibility and acceptability of the VR technology in Phase 2. The outcome measure for this primary aim was the number of participants from which data was used to help design the study protocol.
Measured: From two weeks before surgery up to 30 days after surgery
Aim 2 (Phase 2): Feasibility of Technology Intervention in Perioperative Patients
The primary goal of Aim 2 (Phase 2) of this study was to assess the feasibility of use of the VR technology in children and adolescents undergoing surgery anticipated to cause moderate to severe pain. We defined feasibility as the number of participants who were successfully enrolled and who completed study participation. Study participation was defined as completion of the final study visit.
Measured: From two weeks before surgery until 30 days after surgery
Secondary outcomes (26)
Aim 1 (Phase 1): Preoperative Training Protocol
One of the secondary outcomes in Aim 1 (Phase 1) of this study was to determine how many preoperative VR technology sessions patients would complete to feel comfortable using the VR technology prior to surgery. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. This outcome was measured as number of preoperative sessions completed by participants as a median, IQR.
Measured: Up to two weeks before surgery
Aim 1 (Phase 1): Preoperative Training Protocol, Continued
One of the secondary outcomes in Aim 1 (Phase 1) of this study was to determine how many preoperative VR technology sessions patients would complete to feel comfortable using the VR technology prior to surgery as well as their ability to maintain target heart rate parameters during this preoperative training. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. This outcome measure specifically looked at the session number when target heartrate parameters were first met for > 50% of the session duration as measured using HeartMath reported as a median, IQR.
Measured: Up to two weeks before surgery
Aim 1 (Phase 1): Preoperative Training Protocol, Continued
One of the secondary outcomes in Aim 1 (Phase 1) of this study was to determine how many preoperative VR technology sessions patients would complete to feel comfortable using the VR technology prior to surgery as well as their ability to maintain target heart rate parameters during this preoperative training. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. This outcome measure specifically looked at the percentage of sessions in which patients maintained target heartrate parameters for > 50% of the session duration (assessed using HeartMath), reported as a median, IQR.
Measured: Up to two weeks before surgery
Aim 1 (Phase 1): Preoperative Training Protocol, Continued
One of the secondary outcomes in Aim 1 (Phase 1) of the study was to determine how long participants would use the VR technology during each session prior to surgery. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. The outcome was measured as the session duration in minutes (mean, standard deviation).
Measured: Up to two weeks before surgery
Aim 1 (Phase 1): Post-operative Session Protocol
One of the secondary outcomes in Aim 1 (Phase 1) of this study was to determine how many sessions patients would complete with the VR technology after surgery. Patients were given the option to use the technology for up to 14 days after surgery. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. This outcome measured the number of postoperative sessions completed by participants as a median, IQR.
Measured: Up to two weeks after surgery
Aim 1 (Phase 1): Post-operative Session Protocol, Continued
One of the secondary outcomes in Aim 1 (Phase 1) of this study was to determine how many sessions patients would complete with the VR technology after surgery as well as their ability to maintain target heart rate parameters during these postoperative sessions. Patients were given the option to use the technology for up to 14 days after surgery. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. This outcome measure specifically looked at the percentage of sessions in which patients maintained target heartrate parameters for > 50% of the session duration (assessed using HeartMath), reported as a median, IQR.
Measured: Up to two weeks after surgery
Aim 1 (Phase 1): Post-operative Session Protocol, Continued
One of the secondary outcomes in Aim 1 (Phase 1) of this study was to determine how many sessions patients would complete with the VR technology after surgery as well as their ability to maintain target heart rate parameters during these postoperative sessions. Patients were given the option to use the technology for up to 14 days after surgery. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. This outcome measure specifically looked at the session number when target heartrate parameters were first met for > 50% of the session duration as measured using HeartMath reported as a median, IQR.
Measured: Up to two weeks after surgery
Aim 1 (Phase 1): Postoperative Session Protocol, Continued
One of the secondary outcomes in Aim 1 (Phase 1) of the study was to determine how long participants would use the VR technology during each session after surgery. Patients were given the option to use the technology for up to 14 days after surgery. This outcome measure was designed to help us understand how to design a clinical trial protocol for the subsequent feasibility and acceptability study that would be conducted in Phase 2. The outcome was measured as the session duration in minutes (mean, standard deviation).
Measured: Up to two weeks after surgery
Aim 2 (Phase 2): Rate of Study Enrollment/Randomization
As a measure of feasibility in Phase 2 (Aim 2) of the study, we evaluated our ability to enroll participants in the study as defined as the number of patients who were successfully enrolled and agreed to be randomized to a treatment arm. A total of 70 patients were enrolled, and all 70 participants agreed to be randomized.
Measured: Pre-intervention up to 2 weeks before surgery
Aim 2 (Phase 2): Rate of Study Retention
As a measure of feasibility in Phase 2 (Aim 2) of the study, we evaluated the ability to retain patients in the study. Retention was defined as the number of patients who completed the final study visit.
Measured: From two weeks before surgery up to 30 days after surgery
Aim 2 (Phase 2): Rate of Treatment Adherence (Preoperative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated the number of participants who participated in study activities both pre- and postoperatively. Treatment adherence was defined as the number of participants who completed at least one study activity in each respective time period (before and after surgery). This outcome measure assessed the number of participants who adhered to treatment preoperatively as measured by participant count.
Measured: Up to 2 weeks before surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Preoperative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated participation in study activities both pre- and postoperatively. We evaluated the median number of days in which participants completed at least one technology session and the median number of days in which participants completed at least one diary entry preoperatively (before surgery). We also evaluated the total number of technology sessions done per participant after surgery, the median number of days in which the technology was used after surgery, and the median number of technology sessions per day per participant. Participants who completed at least one session during the study period were included in analysis. This outcome measure evaluates the number of days in which patients completed a technology session preoperatively, reported as median, IQR.
Measured: Up to two weeks before surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Preoperative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated participation in study activities both pre- and postoperatively. We evaluated the median number of days in which participants completed at least one technology session and the median number of days in which participants completed at least one diary entry preoperatively (before surgery). We also evaluated the total number of technology sessions done per participant after surgery, the median number of days in which the technology was used after surgery, and the median number of technology sessions per day per participant. Participants who completed at least one session during the study period were included in analysis. This outcome measure evaluates the number of days in which participants completed a diary entry before surgery, as reported as a median, IQR.
Measured: Up to two weeks before surgery
Aim 2 (Phase 2): Rate of Treatment Adherence (Post-operative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated the number of participants who participated in study activities both pre- and postoperatively. Treatment adherence was defined as the number of participants who completed at least one study activity in each respective time period (before and after surgery). This outcome measure assessed the number of participants who adhered to treatment post-operatively as measured by participant count.
Measured: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated participation in study activities both pre- and postoperatively. We evaluated the median number of days in which participants completed at least one technology session and the median number of days in which participants completed at least one diary entry preoperatively (before surgery). We also evaluated the total number of technology sessions done per participant after surgery, the median number of days in which the technology was used after surgery, and the median number of technology sessions per day per participant. Participants who completed at least one session during the study period were included in analysis. This outcome measure evaluates the total number of completed technology sessions after surgery by participants, reported as a median, IQR.
Measured: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated participation in study activities both pre- and postoperatively. We evaluated the median number of days in which participants completed at least one technology session and the median number of days in which participants completed at least one diary entry preoperatively (before surgery). We also evaluated the total number of technology sessions done per participant after surgery, the median number of days in which the technology was used after surgery, and the median number of technology sessions per day per participant. Participants who completed at least one session during the study period were included in analysis. This outcome measure evaluates the total number of completed diary entries after surgery by participants, reported as a median, IQR.
Measured: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated participation in study activities both pre- and postoperatively. We evaluated the median number of days in which participants completed at least one technology session and the median number of days in which participants completed at least one diary entry preoperatively (before surgery). We also evaluated the total number of technology sessions done per participant after surgery, the median number of days in which the technology was used after surgery, and the median number of technology sessions per day per participant. Participants who completed at least one session during the study period were included in analysis. This outcome measure evaluates the median number of days in which the assigned technology was used by participants after surgery, reported as a median, IQR.
Measured: Up to 30 days
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated participation in study activities both pre- and postoperatively. We evaluated the median number of days in which participants completed at least one technology session and the median number of days in which participants completed at least one diary entry preoperatively (before surgery). We also evaluated the total number of technology sessions done per participant after surgery, the median number of days in which the technology was used after surgery, and the median number of technology sessions per day per participant. Participants who completed at least one session during the study period were included in analysis. This outcome measure evaluates the median number of technology sessions completed per day by participants after surgery, reported as median, IQR.
Measured: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment-specific Satisfaction
As a measure of acceptability in Phase 2 (Aim 2) of the study, we evaluated the number of patients who completed the end-of-study surveys/questionnaires.
Measured: Duration of study participation up to 30 days
Aim 2 (Phase 2): Feasibility of Anxiety Outcome Data Collection
One of the secondary outcomes in Aim 2 (Phase 2) was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect 3 subjective clinical outcomes: pain intensity, pain unpleasantness, and anxiety scores immediately before a technology session preoperatively and immediately before, immediately after, 15-minutes after, and 30-minutes after a technology session after surgery in both treatment arms. Preoperatively, scores were collected only at one time point during the 5 preoperative days. In this measure, we evaluated the number of participants reporting at least one anxiety score for each time point during study participation. Because this study was a study designed to assess feasibility, we did not evaluate/analyze the scores themselves but rather our ability to collect the data from participants.
Measured: Up to 2 weeks before surgery and up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Anxiety Outcome Data Collection, Continued
One of the secondary outcomes in Aim 2 (Phase 2) of the study was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect 3 subjective clinical outcomes: pain intensity, pain unpleasantness, and anxiety scores immediately before a technology session preoperatively and immediately before, immediately after, 15-minutes after, and 30-minutes after a technology session after surgery in both treatment arms. In this measure, we evaluated the median number of anxiety scores reported by participants for each time point after surgery during their study participation as a median, IQR. Because this study was a study designed to assess feasibility, we did not evaluate/analyze the scores themselves but rather our ability to collect the data.
Measured: Up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Unpleasantness Outcome Data Collection
One of the secondary outcomes in Aim 2 (Phase 2) was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect 3 subjective clinical outcomes: pain intensity, pain unpleasantness, and anxiety scores immediately before a technology session preoperatively and immediately before, immediately after, 15-minutes after, and 30-minutes after a technology session after surgery in both treatment arms. Preoperatively, scores were collected only at one time point during the 5 preoperative days. In this measure, we evaluated the number of participants reporting at least one pain unpleasantness score for each time point during study participation. Because this study was a study designed to assess feasibility, we did not evaluate/analyze the scores themselves but rather our ability to collect data from participants
Measured: Up to 2 weeks before surgery and up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Unpleasantness Outcome Data Collection, Continued
One of the secondary outcomes in Aim 2 (Phase 2) of the study was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect 3 subjective clinical outcomes: pain intensity, pain unpleasantness, and anxiety scores immediately before a technology session preoperatively and immediately before, immediately after, 15-minutes after, and 30-minutes after a technology session after surgery in both treatment arms. In this measure, we evaluated the median number of pain unpleasantness scores reported by participants for each time point after surgery during their study participation as a median, IQR. Because this study was a study designed to assess feasibility, we did not evaluate/analyze the scores themselves but rather our ability to collect the data.
Measured: Up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Intensity Outcome Data Collection
One of the secondary outcomes in Aim 2 (Phase 2) was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect 3 subjective clinical outcomes: pain intensity, pain unpleasantness, and anxiety scores immediately before a technology session preoperatively and immediately before, immediately after, 15-minutes after, and 30-minutes after a technology session after surgery in both treatment arms. Preoperatively, scores were collected only at one time point during the 5 preoperative days. In this measure, we evaluated the number of participants reporting at least one pain intensity score for each time point during study participation. Because this study was a study designed to assess feasibility, we did not evaluate/analyze the scores themselves but rather our ability to collect data from participants.
Measured: Up to 2 weeks before surgery and up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Intensity Outcome Data Collection, Continued
One of the secondary outcomes in Aim 2 (Phase 2) of the study was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect 3 subjective clinical outcomes: pain intensity, pain unpleasantness, and anxiety scores immediately before a technology session preoperatively and immediately before, immediately after, 15-minutes after, and 30-minutes after a technology session after surgery in both treatment arms. In this measure, we evaluated the median number of pain intensity scores reported by participants for each time point after surgery during their study participation as a median, IQR. Because this study was a study designed to assess feasibility, we did not evaluate/analyze the scores themselves but rather our ability to collect the data.
Measured: Up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Medication Use Data Collection
One of the secondary outcomes in Aim 2 (Phase 2) of the study was to evaluate the feasibility of collecting data of clinical outcomes that would serve as the basis for efficacy evaluation of the interventions in future clinical trials. We evaluated the ability to collect opioid use postoperatively. In this measure, we evaluated the number of patients in which opioid use data was successfully collected after surgery.
Measured: Post-intervention up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start10 Mar 2022
- Primary completion6 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanessa Olbrecht
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Vanessa Olbrecht, Nemours Children's Clinic
- Investigators
- Vanessa Olbrecht, MD, Principal investigator, Nemours Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943874
- Sponsor's protocol ID
- 2020-0994
- Other IDs
- 5R34AT011218
- Status last verified
- Sep 2026
- First submitted
- 17 May 2021
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with the public, but aggregate data will be publicly available upon request.
Publications
Lin AM, Rachwal B, Asti L, Orgil Z, Santiago I, Ding L, Kashikar-Zuck S, King CD, Williams SE, Black WR, Minneci PC, Olbrecht VA. Feasibility and Acceptability of Perioperative Application of Biofeedback-Based Virtual Reality vs Control for Pain and Anxiety in Children and Adolescents Undergoing Surgery: Pilot Randomized Controlled Trial. J Med Internet Res. 2026 Sep 16;28:e94604. doi: 10.2196/94604.
PubMed 42748484Orgil 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.
PubMed 38742940Orgil 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.
PubMed 36697053
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain in Children and Adolescents After Surgery
- ClinicalTrials.gov ID
- NCT04943874
- Acronym / sponsor ID
- 2020-0994
- Conditions
- Pain, Pain, Postoperative, Pain, Acute, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Vanessa OlbrechtUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Posted 20 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technology Based Intervention 1 (Phase 1) | Other | Device: Technology Based Intervention Group 1 |
| Technology Based Intervention 1 (Phase 2) | Other | Device: Technology Based Intervention Group 1 |
| Technology Based Intervention 2 (Phase 2) | Other | Device: Technology Based Intervention Group 2 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology Based Intervention Group 1In 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. | Device | Technology Based Intervention 1 (Phase 1), Technology Based Intervention 1 (Phase 2) |
| Technology Based Intervention Group 2Participants 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. | Device | Technology Based Intervention 2 (Phase 2) |
Primary outcome
Aim 1 (Phase 1): Treatment Protocol Refinement
Time frame: From two weeks before surgery up to 30 days after surgery
The goal of Aim 1 (Phase 1) of this study was to refine a study (treatment) protocol for the application of the VR technology in children and adolescents undergoing surgery anticipated to cause moderate to severe pain. The study protocol developed in Phase 1 would then be used as the study protocol to assess feasibility and acceptability of the VR technology in Phase 2. The outcome measure for this primary aim was the number of participants from which data was used to help design the study protocol.
Aim 2 (Phase 2): Feasibility of Technology Intervention in Perioperative Patients
Time frame: From two weeks before surgery until 30 days after surgery
The primary goal of Aim 2 (Phase 2) of this study was to assess the feasibility of use of the VR technology in children and adolescents undergoing surgery anticipated to cause moderate to severe pain. We defined feasibility as the number of participants who were successfully enrolled and who completed study participation. Study participation was defined as completion of the final study visit.
26 secondary outcomes
Aim 1 (Phase 1): Preoperative Training Protocol
Time frame: Up to two weeks before surgery
Aim 1 (Phase 1): Preoperative Training Protocol, Continued
Time frame: Up to two weeks before surgery
Aim 1 (Phase 1): Preoperative Training Protocol, Continued
Time frame: Up to two weeks before surgery
Aim 1 (Phase 1): Preoperative Training Protocol, Continued
Time frame: Up to two weeks before surgery
Aim 1 (Phase 1): Post-operative Session Protocol
Time frame: Up to two weeks after surgery
Aim 1 (Phase 1): Post-operative Session Protocol, Continued
Time frame: Up to two weeks after surgery
Aim 1 (Phase 1): Post-operative Session Protocol, Continued
Time frame: Up to two weeks after surgery
Aim 1 (Phase 1): Postoperative Session Protocol, Continued
Time frame: Up to two weeks after surgery
Aim 2 (Phase 2): Rate of Study Enrollment/Randomization
Time frame: Pre-intervention up to 2 weeks before surgery
Aim 2 (Phase 2): Rate of Study Retention
Time frame: From two weeks before surgery up to 30 days after surgery
Aim 2 (Phase 2): Rate of Treatment Adherence (Preoperative)
Time frame: Up to 2 weeks before surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Preoperative)
Time frame: Up to two weeks before surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Preoperative)
Time frame: Up to two weeks before surgery
Aim 2 (Phase 2): Rate of Treatment Adherence (Post-operative)
Time frame: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
Time frame: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
Time frame: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
Time frame: Up to 30 days
Aim 2 (Phase 2): Treatment Adherence, Continued (Post-operative)
Time frame: Up to 30 days after surgery
Aim 2 (Phase 2): Treatment-specific Satisfaction
Time frame: Duration of study participation up to 30 days
Aim 2 (Phase 2): Feasibility of Anxiety Outcome Data Collection
Time frame: Up to 2 weeks before surgery and up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Anxiety Outcome Data Collection, Continued
Time frame: Up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Unpleasantness Outcome Data Collection
Time frame: Up to 2 weeks before surgery and up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Unpleasantness Outcome Data Collection, Continued
Time frame: Up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Intensity Outcome Data Collection
Time frame: Up to 2 weeks before surgery and up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Pain Intensity Outcome Data Collection, Continued
Time frame: Up to 2 weeks after surgery
Aim 2 (Phase 2): Feasibility of Medication Use Data Collection
Time frame: Post-intervention up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42748484Lin AM, Rachwal B, Asti L, Orgil Z, Santiago I, Ding L, Kashikar-Zuck S, King CD, Williams SE, Black WR, Minneci PC, Olbrecht VA. Feasibility and Acceptability of Perioperative Application of Biofeedback-Based Virtual Reality vs Control for Pain and Anxiety in Children and Adolescents Undergoing Surgery: Pilot Randomized Controlled Trial. J Med Internet Res. 2026 Sep 16;28:e94604. doi: 10.2196/94604.
- Derived from this study: PubMed 38742940Orgil 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.
- Derived from this study: PubMed 36697053Orgil 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.
- Individual participant dataSharing planned: No. IPD will not be shared with the public, but aggregate data will be publicly available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Olbrecht, MD principal investigator
Nemours Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Based Intervention Group 1 and Technology Based Intervention Group 2 in people with Pain and Pain, Postoperative, run by Vanessa Olbrecht at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 (Phase 1): Treatment Protocol Refinement (time frame: From two weeks before surgery up to 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943874, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.