Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (guided meditation)
Patients listen to 10 minutes of guided meditation prior to surgery.
  • Behavioral: Behavioral Intervention
    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
  • Other: Electronic Health Record Review
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
Active Comparator
Arm II (noise cancelling headphones)
Patients wear noise cancelling headphones for 10 minutes prior to surgery.
  • Behavioral: Behavioral Intervention
    Wear noise cancelling headphones
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
  • Other: Electronic Health Record Review
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Maryanna Klatt, PhD
614-366-1056
Maryanna.Klatt@Osumc.edu

More Details

NCT ID
NCT06949943
Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

The Ohio State University Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.