Pain, Pain, Acute, Pain, Postoperative, Surgery
Conditions
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.
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.
Interventions
DEVICETechnology 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.
DEVICETechnology 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Vanessa Olbrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1: Treatment protocol refinement | Duration of study up to 30 days | Frequency of sessions |
| Aim 2: Feasibility of technology intervention in perioperative patients | Pre-intervention | Rate of study recruitment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 1: Preoperative training protocol | Up to two weeks pre-operatively | Frequency of preoperative training session |
| Aim 2: Effect of technology on medication use | Duration of hospital stay (2-7 days) | Medications used will be collected |
| Aim 2: Effect of technology on pain | Preoperatively (up to 5 days) | 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 2-7 days) | Semi-structured interview |
| 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 1: Post-operative session protocol | Up to two week post surgery | Frequency of post-operative intervention session |
Countries
United States
Outcome results
None listed