Recruiting

Mindfulness Intervention

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07026786

Conditions

Pain After Surgery

Anxiety After Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Intervention

Study Details

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

Study ID

NCT07026786

Start date

Feb 20, 2026

Status verified date

Apr, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mindfulness 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 and complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires.

no intervention: Standard Care

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

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 outcome measure

  • Percentage of participants who completed all mindfulness interventions as measured by study logs [ Time Frame: Up to one year ]

Central Contacts and Locations

Central contacts

Emily Simon, MD

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

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Emily Simon

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

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Colorectal surgery patients
  • Mindfulness
  • Enhanced Recovery After Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-04-13.