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Using Mindfulness in an Enhanced Recovery After Surgery Protocol 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07026786
Enrollment
50
Registered
2025-06-18
Start date
2026-02-20
Completion date
2027-09-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety After Surgery, Pain After Surgery

Keywords

Colorectal surgery patients, Mindfulness, Enhanced Recovery After Surgery

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.

Interventions

BEHAVIORALMindfulness Intervention

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.

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER
UH Connor Whole Health
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of participants who completed all mindfulness interventions as measured by study logsUp to one year

Secondary

MeasureTime frame
Percentage of participants who complete all study questionnaires/text message reminders as measured by study logsUp to one year

Countries

United States

Contacts

CONTACTEmily Simon, MD
emily.simon2@uhhospitals.org(216) 844-5025
PRINCIPAL_INVESTIGATOREmily Steinhagen, MD

University Hospitals Cleveland Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026