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

University Hospitals (UH)

Status: Not yet enrolling

Conditions: Anxiety After Surgery; Pain After Surgery

Treatments: Behavioral: Mindfulness Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07026786

STUDY20250408

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Mindfulness Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Intervention

Standard Care

No Intervention group

Description:

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.