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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Surgery for palliative purposes only

Surgery for ostomy take-down only

Discharged on day of surgery

History of substance use disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mindfulness InterventionExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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