Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain After Surgery; Anxiety After Surgery

• Registration Number: NCT07026786
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2025-10-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of participants who completed all mindfulness interventions as measured by study logs	Up to one year

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs	Up to one year

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States