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NCT Number: NCT07026786

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

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.

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Key information

Conditions

Pain After Surgery Anxiety After Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Emily Simon

CONTACT

[email protected]

(216) 844-5025

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to one year

Secondary outcomes

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

    Time frame: Up to one year

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Simon, MD

CONTACT

[email protected]

(216) 844-5025

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • UH Connor Whole Health

Registry information

Official study title

Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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