Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Intervention.
- Who it may be relevant to
- Registry conditions: Pain After Surgery, Anxiety After Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study
Overview
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.
Interventions
- Behavioral 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 measures
- Percentage of participants who completed all mindfulness interventions as measured by study logs [Time frame: Up to one year]
Secondary outcome measures (1)
- Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs [Time frame: Up to one year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University Hospitals Cleveland Medical Center — Cleveland
Identifiers
NCT: NCT07026786 · STUDY20250408