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NCT Number: NCT06949943

Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery

This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery, influencing the success and quality of a patient's recovery. While medication is often prescribed to improve anxiety symptoms, research has showed that mindfulness techniques can be used to decrease anxiety, improve comfort, and can impact both psychological and physiologic symptoms. Completing pre-operative guided meditation may work well to reduce pre-operative anxiety in patients undergoing cancer directive surgery.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Maryanna Klatt, PhD

CONTACT

[email protected]

614-366-1056

Maryanna Klatt, PhD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To improve is pre-operative patient anxiety in surgical settings.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients listen to 10 minutes of guided meditation prior to surgery.

ARM II: Patients wear noise cancelling headphones for 10 minutes prior to surgery.

After completion of study intervention, patients are followed up for up to 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants will be recruited among patients who are scheduled for cancer-directed surgery
  • Participants must be 18 years or older

Exclusion criteria

  • Participants will be excluded from the study if they cannot speak English (as the meditation is recorded in English)
  • Currently incarcerated
  • Have a diagnosis of dementia
  • Are admitted to the intensive care unit (ICU)
  • Have a hearing impairment that would make them unable to hear the recorded meditation

Treatment and study plan

behavioral intervention

Behavioral

Listen to guided meditation

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Electronic Health Record Review

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Pre-operative anxiety (PROMIS Anxiety scale)

    Time frame: Pre and post intervention, approximately 10 minutes

    Measured with the Patient Reported Outcome Measurement Information System Anxiety. PROMIS Anxiety short form is an 8-item scale used to assess anxiety in individuals 18 years or older. Each item is on a 5-point scale to be summed, with higher scores indicating greater anxiety.

  2. Pre-operative anxiety (single-item visual analog scale)

    Time frame: Pre and post intervention, approximately 10 minutes

    Measured by a single-item visual analog scale. The single-item visual analog scale will be used to assess momentary anxiety. The item will ask, "On a scale of 1 to 10, how anxious do you feel right now?" and patients will rate the level of anxiety on a scale of 0 to 10 (0=not at all anxious, 10=extremely anxious).

Secondary outcomes

  1. Post-operative opiate use

    Time frame: Up to 6 months post intervention

    Will be extracted from the electronic medical record via chart review. Days of opioid use will be calculated and compared between intervention and control groups.

  2. Post-operative morphine equivalent dose

    Time frame: Up to 6 months post intervention

    Will be extracted from the electronic medical record via chart review. Daily morphine equivalent dose for each opioid prescribed will be calculated and compared between intervention and control groups.

  3. Post-operative average daily morphine

    Time frame: Up to 6 months post intervention

    Will be extracted from the electronic medical record via chart review. Average daily morphine equivalent dose will be calculated and compared between intervention and control groups.

  4. Length of stay

    Time frame: Up to 6 months post intervention

    Will be extracted from the electronic medical record via chart review.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
May 7, 2026

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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