Mindfulness to support recovery after colorectal surgery
Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study
This study will try teaching adults having colorectal surgery simple mindfulness exercises to help them feel calmer and manage pain after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07026786 on ClinicalTrials.gov |
What this trial studies
Participants having colorectal bowel resection and enrolled in the hospital's ERAS pathway will be randomly assigned to a mindfulness intervention or to standard treatment. Those in the mindfulness arm receive a 30-minute preoperative Zoom session teaching simple exercises (deep breathing, sensory grounding, present-moment focus) and watch a short review video the day after surgery. All participants complete questionnaires about pain, anxiety, and medication use, and a subset will do a semi-structured Zoom interview 2 weeks to 1 month after surgery. Investigators will also collect demographic and surgical details and track postoperative pain scores and opioid consumption, and access to the mindfulness curriculum will be provided to those not originally randomized to it.
Who should consider this trial
Good fit: Adults (18+) scheduled for bowel resection enrolled in the University Hospitals ERAS pathway who will stay at least one night in the hospital, speak English, and have internet access for Zoom are ideal candidates.
Not a fit: Patients having only same-day discharge, undergoing palliative or ostomy take-down procedures, those with active substance use disorder, severe sensory or cognitive impairment, no internet access, or insufficient English proficiency are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could help reduce postoperative anxiety and pain and may lower the need for opioid pain medication.
How similar studies have performed: Mindfulness interventions have shown some benefit for anxiety and pain in surgical and pain-management settings, but integrating mindfulness into an ERAS protocol for colorectal surgery is relatively novel and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Emily Steinhagen, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Emily Simon, MD
- Email: emily.simon2@uhhospitals.org
- Phone: (216) 844-5025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.