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Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients
Not Recruiting
Trial ID: NCT03764839
Purpose
The primary purpose of this study is to determine the feasibility and preliminary efficacy of
a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma
surgery patients (compared to an active control group that receives digital health
education).
Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical
Success"
Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the
study (feasibility). Of those who complete My Surgical Success, the investigators expect 80%
satisfaction ratings, and 80% perceived utility of the information learned.
Aim 2: Determine group differences in time to post-surgical pain and opioid cessation.
Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical
pain and opioid cessation compared to the HE Control Group.
Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to
post-surgery).
Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain
catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE
Control group.
Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS
Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation,
Fatigue, and Pain Intensity).
Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function
and lower pain related interference compared to the HE Control Group.
The goal of this research is to advance our understanding regarding the feasibility and
effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine
treatment) and its impact on post-surgical outcomes.
Official Title
"My Surgical Success": A Randomized Controlled Trial of a Perioperative Digital Behavioral Pain Medicine Treatment Tested in Orthopedic Trauma Patients
Stanford Investigator(s)
Beth Darnall
Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain) and, by courtesy, of Psychiatry and Behavioral Sciences (General Psychiatry & Psychology (Adult))
Eligibility
Inclusion Criteria:
- Age 18-80 years
- Undergoing a scheduled surgery for orthopedic trauma
- Post-surgery up to 7 days
- English fluency
- Ability and willingness to complete electronic study procedures including
questionnaires, assessments, and receipt of treatment.
Exclusion Criteria:
- Any conditions causing inability to complete study procedures (e.g. cognitive ability,
mental status, medical status) or lack of access to internet and phone that would
prevent participation in study procedures - at the discretion of the staff member.
- long-term opioid use prior to surgery
- Known pregnancy
- Ongoing legal action related to pain or disability claim
- Multiple surgeries and/or infections
- Injury is not fracture related or non-trauma surgery
- Documented history of alcohol abuse
Intervention(s):
behavioral: Perioperative Digital Behavioral Pian Medicine "My Surgical Success"
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Natalie Tanner
650-723-8386