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

NCT07026786 | Recruiting

• 1 other identifier: STUDY20250408
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain After Surgery; Anxiety After Surgery

Keywords

Colorectal surgery patients; Mindfulness; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who completed all mindfulness interventions as measured by study logs

  Up to one year

Secondary Outcomes (1)

• Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs

  Up to one year

Study Arms (2)

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.

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.

Interventions

Mindfulness Intervention BEHAVIORAL

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.

Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UH Connor Whole Health: collaborator
• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Study Officials

• Emily Steinhagen, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Simon, MD

CONTACT

(216) 844-5025; emily.simon2@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)