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Active, not recruitingNCT07924735Updated Nov 9, 2026

Opioid Sparing Cognitive Behavioral Therapy (CBT) Intervention to Manage Acute Pain, and Pain Catastrophizing in Surgical Patients

An interventional study of In-person cognitive behavioral therapy and Virtual reality-delivered cognitive behavioral therapy in Post-surgical Pain, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 2 months after the study started (first participant enrolled Jul 2020, registered Oct 2026).
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research is to compare post-surgical pain of patients having the cognitive behavioral therapy (CBT) to those patients not receiving the additional intervention.

02

Conditions studied

  • Post-surgical Pain

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Keywords

  • Cognitive Behavioral Therapy (CBT)
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Candidates for elective colorectal surgery at Mayo Clinic Jacksonville, and who have planned inpatient admission.

Exclusion criteria

Exclusion Criteria:

  • Patients who are expected to have a multi-organ resection for cancer
  • Patients who have an established diagnosis of cognitive disorders including dementia
  • Unable to communicate in English
  • From a vulnerable population
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • No intervention
    Usual Care

    Participants receive standard preoperative education and postoperative care processes for elective colorectal surgery.

  • Experimental
    In-Person CBT plus Usual Care

    Participants receive usual care plus a 1-hour preoperative CBT session at least 1 week before

    Behavioral: In-person cognitive behavioral therapy

  • Experimental
    VR-CBT plus Usual Care

    Participants receive usual care plus a 30-minute virtual reality (VR) immersive CBT intervention before surgery using a Meta Quest 2 headset and a 30-minute check-in call within 48 hours of surgery.

    Behavioral: Virtual reality-delivered cognitive behavioral therapy

Interventions

  • BehavioralIn-person cognitive behavioral therapy

    The intervention consists of a 1-hour, in-person cognitive behavioral therapy session delivered at least 1 week before surgery. The session is intended to address pain-related thoughts, expectations, coping strategies, and behavioral approaches for managing acute postoperative pain. Participants also receive a 30-minute check-in telephone call within 48 hours before surgery and may receive a QR code or website link to review intervention content after the session.

  • BehavioralVirtual reality-delivered cognitive behavioral therapy

    The intervention consists of a 30-minute, non-interactive virtual reality immersive experience delivered before surgery using a Meta Quest 2 headset in the clinic setting. The virtual reality content is designed to provide cognitive behavioral therapy material similar to the in-person CBT arm, including pain education, expectation setting, coping strategies, and behavioral approaches for managing acute postoperative pain. Participants also receive a 30-minute check-in telephone call within 48 hours before surgery and may receive a QR code or website link to review intervention content after the session.

06

What researchers measure

Primary outcomes

  1. Change in Pain Catastrophizing Scale Score

    The Pain Catastrophizing Scale is a participant-reported questionnaire that measures catastrophic thinking related to pain. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.

    Time frame: Within 24 hours post-surgery (prior to hospital discharge), 1 month post-discharge

  2. Average Postoperative Numeric Pain Rating Scale Score During Inpatient Hospitalization

    Postoperative pain intensity will be measured using the Numeric Pain Rating Scale documented in the electronic medical record. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. The average score during the inpatient postoperative hospitalization will be summarized for each participant.

    Time frame: From surgery completion through hospital discharge (approximately 5 days)

  3. Total Inpatient Opioid Use After Surgery

    Total opioid medication administered after surgery during the inpatient postoperative hospitalization will be abstracted from the electronic medical record, reported as morphine milligram equivalents

    Time frame: From surgery completion through hospital discharge (approximately 5 days)

  4. Number of Participants Prescribed an Opioid at Hospital Discharge

    The number of participants with an opioid medication prescribed at hospital discharge will be abstracted from the discharge medication record.

    Time frame: At hospital discharge after surgery (approximately 5 days)

Secondary outcomes

  1. Change Surgical Recovery Scale Score

    The Surgical Recovery Scale is a participant-reported questionnaire used to assess recovery after surgery. The scale consists of 13 questions, scored on a scale of 0 = Not at All and 5 = All of the Time. Higher scores indicate better recovery toward pre-surgical physical, functional, and social status.

    Time frame: Within 24 hours before hospital discharge after surgery, 1 month post-discharge

  2. Number of Participants With an Opioid Prescription Refill After Discharge

    The number of participants with at least one opioid prescription refill after hospital

    Time frame: From hospital discharge through 1 month after discharge

  3. Number of Participants With an Emergency Department Visit After Discharge

    The number of participants with at least one emergency department visit after hospital discharge will be abstracted from the medical record.

    Time frame: From hospital discharge through 1 month after discharge

  4. Number of Participants Readmitted to the Hospital After Discharge

    The number of participants with at least one hospital readmission after hospital discharge

    Time frame: From hospital discharge through 1 month after discharge

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924735
Lead sponsor
Mayo Clinic
Responsible party
Dorin T. Colibaseanu, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 9, 2026
Start date
Jul 21, 2020
Primary completion
Dec 31, 2024
Completion
Jul 31, 2030 (estimated)
Last update
Nov 9, 2026

Study contacts

Dorin Colibaseanu, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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