Pain After SurgeryNCT07026786
Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery
A study testing Mindfulness Intervention in people with Pain After Surgery and Anxiety After Surgery, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. Participants will be randomized (like a flip of a coin) into one of two groups: Mindfulness Intervention or Standard Treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain After Surgery, Anxiety After Surgery
- What is being tested?
- Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2026to 1 Sep 2027
- 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
- Patients scheduled for a bowel resection and enrolled in the UH Institutional ERAS pathway
- Patients will be admitted to the inpatient hospital for at least one day postoperatively
- Aged 18 or older
- Receiving surgery at designated University Hospitals locations (Cleveland Medical Center, Ahuja, St. John's Medical Center)
- English-speaking
- Access to the internet via phone, laptop, or iPad
Who cannot join
- Surgery for palliative purposes only
- Surgery for ostomy take-down only
- Discharged on day of surgery
- History of substance use disorder
- Allergy or intolerance to all opioids
- Insufficient English proficiency
- No access to the internet outside clinical settings
- Significant visual, hearing or cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Emily Simon, (216) 844-5025, emily.simon2@uhhospitals.org
About this study
Official title: Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study
This study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. Participants will be randomized (like a flip of a coin) into one of two groups: Mindfulness Intervention or Standard Treatment. Those in the Mindfulness group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present.
On the day after surgery, participants will watch a short video review of the mindfulness exercises.
Read more
Regardless of the group assigned, participants may be asked to complete questionnaires, and some participants will be asked to complete a semi-structured interview via Zoom, about 2 weeks to 1 month after surgery. Additionally, access to the mindfulness curriculum will be provided to those not randomized to that group. Investigators will collect information such as age, surgery details, pain levels, and pain medication usage. Participants will also fill out surveys before and after surgery to assess physical and mental well-being. All personal information will be kept safe, and interviews or Zoom sessions will be deleted after notes are taken without names attached.
Participants will be in this study for about 4 weeks.
- Conditions
- Pain After Surgery, Anxiety After Surgery
- Being tested
- Mindfulness Intervention
- Keywords
- Colorectal surgery patients, Mindfulness, Enhanced Recovery After Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
Those in the Mindfulness Intervention group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. After surgery, these participants will receive a refresher on the mindfulness curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | Those in the Mindfulness Intervention group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. After surgery, these participants will receive a refresher on the mindfulness curriculum and complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires. Receives: Behavioral: Mindfulness Intervention |
| Standard Care | No intervention | Participants will undergo standard of care protocols prior to and after surgery, with no specific intervention related to the study protocol. After surgery, these participants will complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who completed all mindfulness interventions as measured by study logs
Measured: Up to one year
Secondary outcomes (1)
Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start20 Feb 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UH Connor Whole Health
- Responsible party
- Principal investigator, Emily Steinhagen, University Hospitals Cleveland Medical Center
- Investigators
- Emily Steinhagen, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026786
- Sponsor's protocol ID
- STUDY20250408
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2025
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study
- ClinicalTrials.gov ID
- NCT07026786
- Acronym / sponsor ID
- STUDY20250408
- Conditions
- Pain After Surgery, Anxiety After Surgery
- Keywords
- Colorectal surgery patients, Mindfulness, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- UH Connor Whole Health
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Jun 2025 (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.
This study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. Participants will be randomized (like a flip of a coin) into one of two groups: Mindfulness Intervention or Standard Treatment. Those in the Mindfulness group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present.
On the day after surgery, participants will watch a short video review of the mindfulness exercises.
Regardless of the group assigned, participants may be asked to complete questionnaires, and some participants will be asked to complete a semi-structured interview via Zoom, about 2 weeks to 1 month after surgery. Additionally, access to the mindfulness curriculum will be provided to those not randomized to that group. Investigators will collect information such as age, surgery details, pain levels, and pain medication usage. Participants will also fill out surveys before and after surgery to assess physical and mental well-being. All personal information will be kept safe, and interviews or Zoom sessions will be deleted after notes are taken without names attached.
Participants will be in this study for about 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness InterventionThose in the Mindfulness Intervention group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. After surgery, these participants will receive a refresher on the mindfulness curriculum and complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires. |
| Standard Care | No intervention | –Participants will undergo standard of care protocols prior to and after surgery, with no specific intervention related to the study protocol. After surgery, these participants will complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for a bowel resection and enrolled in the UH Institutional ERAS pathway
- Patients will be admitted to the inpatient hospital for at least one day postoperatively
- Aged 18 or older
- Receiving surgery at designated University Hospitals locations (Cleveland Medical Center, Ahuja, St. John's Medical Center)
- English-speaking
Key exclusion criteria (8 listed)
- Surgery for palliative purposes only
- Surgery for ostomy take-down only
- Discharged on day of surgery
- History of substance use disorder
- Allergy or intolerance to all opioids
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 |
|---|---|---|
| Mindfulness InterventionThose in the Mindfulness Intervention group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. After surgery, these participants will receive a refresher on the mindfulness curriculum. | Behavioural | Mindfulness Intervention |
Primary outcome
Percentage of participants who completed all mindfulness interventions as measured by study logs
Time frame: Up to one year
1 secondary outcome
Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs
Time frame: Up to one year
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 13 Apr 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.
Emily Steinhagen, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention in people with Pain After Surgery and Anxiety After Surgery, run by University Hospitals Cleveland Medical Center 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Apr 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?
Contact Emily Simon, MD ((216) 844-5025, emily.simon2@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who completed all mindfulness interventions as measured by study logs (time frame: Up to one year). 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 13 Apr 2026.