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Completed

NCT Number: NCT06233253

Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy

This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVE:

I. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive usual care prior to their scheduled screening colonoscopy.

GROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy.

After completion of study intervention, patients are followed up 1-2 days post-colonoscopy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients must be ages 45-75
  • Patients must be at average risk for colorectal cancer (CRC)
  • Patients must have scheduled their first-time screening colonoscopy as an outpatient at Ohio State University (OSU) at least 14 days in advance
  • Patients must be able to speak and read English
  • Patients must have daily access to a working telephone, email address, and internet connection
  • Patients must provide consent

Exclusion criteria

  • Previous colonoscopy
  • Colonoscopy for diagnostic purposes
  • Auditory or visual impairment that prevents internet use
  • Previous cancer diagnosis (other than skin cancer)
  • Previous diagnosis of a mental health disorder
  • Current mental health treatment
  • Family history of CRC
  • Personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Confirmed or suspected hereditary CRC syndrome, such as familial adenomatous polyposis or Lynch syndrome

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

medical chart review

Other

Ancillary studies

Other names: Chart Review

Online Mindfulness Meditation

Behavioral

Receive an online mindfulness intervention

Other names: Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress Reduction, Web-Based Mindfulness Meditation

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Retention rate (Feasibility)

    Time frame: Up to 4 weeks

    Feasibility will be assessed by the number of patients referred, number of participants recruited, and missing data from surveys and medical records. Feasibility will be achieved with a retention rate of 90% throughout the intervention. An independent samples t-test will be conducted to compare State-Trait Anxiety Inventory: State-Subscale (STAI-S) scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.

  2. Satisfaction with the intervention (Acceptability)

    Time frame: At follow-up (1-2 days after the colonoscopy)

    Acceptability will be assessed by the number of intervention materials accessed and time to complete study activities (infographics, meditations, and surveys) via embedded REDCap metrics. Participants within the MBI group will also report meditation satisfaction and state mindfulness immediately after each meditation in addition to intervention satisfaction during the follow-up survey. Will report an average satisfaction score with the intervention >= 6.0, measured using a 7-point Likert scale. An independent samples t-test will be conducted to compare STAI-S scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.

Secondary outcomes

  1. Colonoscopy nervousness

    Time frame: At pre-colonoscopy assessment

    Anxiety specific to the bowel prep and colonoscopy will be assessed using a visual analogue scale. Will be analyzed using t-test.

  2. Mindfulness

    Time frame: At follow-up (1-2 days after the colonoscopy)

    Will measure the trait mindfulness using The Philadelphia Mindfulness Scale, a 20-item self-report with subscales of awareness and acceptance. Will be analyzed using t-test.

  3. Mindfulness knowledge

    Time frame: At follow up (1-2 days after the colonoscopy)

    Will be assessed using a 5-item score about mindfulness. An independent samples t-test will be conducted to compare STAI-S scores.

  4. Colorectal screening knowledge

    Time frame: At follow up (1-2 days after the colonoscopy)

    Will be assessed using a 5-item score about colorectal (CRC) screening. Will be analyzed using t-test.

  5. Attitudes about CRC and CRC screening

    Time frame: At follow up (1-2 days after the colonoscopy)

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

  6. Bowel prep adherence

    Time frame: At pre-colonoscopy assessment

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using chi-square test.

  7. Bowel prep difficulty

    Time frame: At pre-colonoscopy assessment

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

  8. Bowel prep quality

    Time frame: Up to 4 weeks

    Will be measured using the Boston Bowel Preparation Scale or 5-point Likert scale and medical chart review. Will be analyzed using t-test.

  9. Cancellation/no-show

    Time frame: At pre-colonoscopy assessment

    Will be measured by attendance. Will be analyzed using chi-square test.

  10. Heart rate

    Time frame: Up to 4 weeks

    Will be measured in beats per minute using medical chart review. Will be analyzed using t-test.

  11. Blood pressure

    Time frame: Up to 4 weeks

    Will be measured in millimeter of mercury using chart review at time of check-in (the first recorded) to the endoscopy suite holding area. Will be analyzed using t-test.

  12. Sedative dose

    Time frame: Up to 4 weeks

    Will be measured in milligrams using chart review. Will be analyzed using t-test.

  13. Procedural time

    Time frame: Up to 4 weeks

    Will be measured in minutes using medical chart review. Will be analyzed using t-test.

  14. Cecal intubation time

    Time frame: At post-colonoscopy

    Will be measured in minutes using medical chart review. Will be analyzed using t-test.

  15. Endoscopy suite time

    Time frame: Up to 4 weeks

    Will be measured in minutes using medical chart review. Will be analyzed using t-test.

  16. Procedure satisfaction

    Time frame: At follow up (1-2 days after the colonoscopy)

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

  17. Intent for future CRC screening

    Time frame: At follow up (1-2 days after the colonoscopy)

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2024
Registry last updated
Feb 24, 2025

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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