Post-surgical PainNCT07924735
Opioid Sparing Cognitive Behavioral Therapy (CBT) Intervention to Manage Acute Pain, and Pain Catastrophizing in Surgical Patients
A study testing In-person cognitive behavioral therapy and Virtual reality-delivered cognitive behavioral therapy in people with Post-surgical Pain, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-surgical Pain
- What is being tested?
- In-person cognitive behavioral therapy and Virtual reality-delivered cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for elective colorectal surgery at Mayo Clinic Jacksonville, and who have planned inpatient admission.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Post-surgical Pain
- Being tested
- In-person cognitive behavioral therapy, Virtual reality-delivered cognitive behavioral therapy
- Keywords
- Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person cognitive behavioral therapyBehavioural
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.
Virtual reality-delivered cognitive behavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants receive standard preoperative education and postoperative care processes for elective colorectal surgery. |
| In-Person CBT plus Usual Care | Experimental | Participants receive usual care plus a 1-hour preoperative CBT session at least 1 week before Receives: Behavioral: In-person cognitive behavioral therapy |
| VR-CBT plus Usual Care | Experimental | 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. Receives: Behavioral: Virtual reality-delivered cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours post-surgery (prior to hospital discharge), 1 month post-discharge
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.
Measured: From surgery completion through hospital discharge (approximately 5 days)
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
Measured: From surgery completion through hospital discharge (approximately 5 days)
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.
Measured: At hospital discharge after surgery (approximately 5 days)
Secondary outcomes (4)
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.
Measured: Within 24 hours before hospital discharge after surgery, 1 month post-discharge
Number of Participants With an Opioid Prescription Refill After Discharge
The number of participants with at least one opioid prescription refill after hospital
Measured: From hospital discharge through 1 month after discharge
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.
Measured: From hospital discharge through 1 month after discharge
Number of Participants Readmitted to the Hospital After Discharge
The number of participants with at least one hospital readmission after hospital discharge
Measured: From hospital discharge through 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start21 Jul 2020
- Primary completion31 Dec 2024
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorin T. Colibaseanu, M.D., Mayo Clinic
- Investigators
- Dorin Colibaseanu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924735
- Sponsor's protocol ID
- 20-004728
- Status last verified
- Nov 2026
- First submitted
- 17 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Sparing Cognitive Behavioral Therapy (CBT) Intervention to Manage Acute Pain, and Pain Catastrophizing in Surgical Patients
- ClinicalTrials.gov ID
- NCT07924735
- Acronym / sponsor ID
- 20-004728
- Conditions
- Post-surgical Pain
- Keywords
- Cognitive Behavioral Therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants receive standard preoperative education and postoperative care processes for elective colorectal surgery. |
| In-Person CBT plus Usual Care | Experimental | Behavioral: In-person cognitive behavioral therapyParticipants receive usual care plus a 1-hour preoperative CBT session at least 1 week before |
| VR-CBT plus Usual Care | Experimental | Behavioral: Virtual reality-delivered cognitive behavioral therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for elective colorectal surgery at Mayo Clinic Jacksonville, and who have planned inpatient admission.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person cognitive behavioral therapyThe 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. | Behavioural | In-Person CBT plus Usual Care |
| Virtual reality-delivered cognitive behavioral therapyThe 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. | Behavioural | VR-CBT plus Usual Care |
Primary outcome
Change in Pain Catastrophizing Scale Score
Time frame: Within 24 hours post-surgery (prior to hospital discharge), 1 month post-discharge
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.
Average Postoperative Numeric Pain Rating Scale Score During Inpatient Hospitalization
Time frame: From surgery completion through hospital discharge (approximately 5 days)
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.
Total Inpatient Opioid Use After Surgery
Time frame: From surgery completion through hospital discharge (approximately 5 days)
Total opioid medication administered after surgery during the inpatient postoperative hospitalization will be abstracted from the electronic medical record, reported as morphine milligram equivalents
Number of Participants Prescribed an Opioid at Hospital Discharge
Time frame: At hospital discharge after surgery (approximately 5 days)
The number of participants with an opioid medication prescribed at hospital discharge will be abstracted from the discharge medication record.
4 secondary outcomes
Change Surgical Recovery Scale Score
Time frame: Within 24 hours before hospital discharge after surgery, 1 month post-discharge
Number of Participants With an Opioid Prescription Refill After Discharge
Time frame: From hospital discharge through 1 month after discharge
Number of Participants With an Emergency Department Visit After Discharge
Time frame: From hospital discharge through 1 month after discharge
Number of Participants Readmitted to the Hospital After Discharge
Time frame: From hospital discharge through 1 month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorin Colibaseanu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person cognitive behavioral therapy and Virtual reality-delivered cognitive behavioral therapy in people with Post-surgical Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Catastrophizing Scale Score (time frame: Within 24 hours post-surgery (prior to hospital discharge), 1 month post-discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.