Clinical trial NCT07026786: Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery
Official title: Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain After Surgery
Anxiety After Surgery
Keywords: Colorectal surgery patients
Mindfulness
Enhanced Recovery After Surgery
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: UH Connor Whole Health
First posted: 2025-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Percentage of participants who completed all mindfulness interventions as measured by study logs
timeFrame: Up to one year
Secondary outcomes:
measure: Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs
timeFrame: Up to one year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Emily Steinhagen, MD
role: PRINCIPAL_INVESTIGATOR
References: