The Adolescent Surgery Experience: A Mixed Methods Analysis

NCT05482919 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 501

Last updated 2024-09-26

No results posted yet for this study

Summary

New chronic pain and opioid use are reported as prevalent among adolescents undergoing major surgery; many unanswered questions remain regarding recovery and the anticipated pain trajectory across procedures and the interaction between pain treatment, acute inflammation and new chronic pain. Broadly, the proposed study will characterize the adolescent's postoperative recovery experience, and establish the anticipated pain trajectory across a range of procedures.

Conditions

  • Pain, Postoperative
  • Pain
  • Pain, Acute
  • Pain, Chronic
  • Adolescent Behavior
  • Opioid Use

Interventions

BEHAVIORAL

Baseline Survey

The baseline survey, initial PHQ-9 and GAD-7, could be collected prior to surgery after consent, or on the day of surgery, for participants who are undergoing elective surgery or urgent procedures and did not attend pre-operative clinic. Demographic information such as race and ethnicity, pain medications and pain history and baseline self-reported health information will be collected. It will take about 15 minutes to complete.

BEHAVIORAL

Post Operative Surveys

Post operative surveys will be collected at one week, two weeks, one month, then monthly up to 6 months after surgery with total of 7 post-op surveys. Refer to Table 1 for visit windows. The study survey could be collected by phone, REDCap texting or email per the subject's preference. Survey content will also include: daily average and maximum self-reported pain scores on a 0-10 Numeric Rating Scale (NRS) pain scale, average hours of sleep, anxiety and depression screens using the PHQ-9 and GAD-7 questionnaires (Months 1, 3, and 5), pain location and quality, percentage of day spent in pain, satisfaction with recovery using a five-point Likert scale, and type, quantity and timing of any medications used for pain (including opioid alternatives).

BEHAVIORAL

Qualitative Interviews

Using sampling to identify adolescents who exhibit higher pain scores or prolonged opioid use compared to peers after completion of the first three surveys (pre-operative, Week 1, Week 2), the study will also select a representative sample of adolescents who are recovering as anticipated. Examples of delayed recovery include a higher proportion of moderate to severe pain scores, dissatisfaction with recovery and prolonged opioid use compared to peers. As a balancing measure, the upper limit of adolescents who are perceived to exhibit delayed recovery that are approached for interviews will be capped at a 3:1 ratio compared to those who are recovering as anticipated, and Investigators will prioritize an equal demographic distribution among the two groups. Interviews will take place over the phone or through a CHOP approved vendor at 1 and 3 months after surgery; audio will be recorded with participant consent.

Sponsors & Collaborators

Principal Investigators

  • Tori N Sutherland, MD MPH · CHOP

Eligibility

Min Age
11 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2023-10-11
Completion
2023-10-15

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482919 on ClinicalTrials.gov