The Adolescent Surgery Experience: A Mixed Methods Analysis

CompletedOBSERVATIONAL
Enrollment

501

Participants

Timeline

Start Date

June 14, 2022

Primary Completion Date

October 11, 2023

Study Completion Date

October 15, 2023

Conditions
Pain, PostoperativePainPain, AcutePain, ChronicAdolescent BehaviorOpioid 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.

Trial Locations (1)

19104

The Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
lead

Children's Hospital of Philadelphia

OTHER