Clinical trial NCT06949943: Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery
Official title: Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-operative anxiety (PROMIS Anxiety scale)
timeFrame: Pre and post intervention, approximately 10 minutes
measure: Pre-operative anxiety (single-item visual analog scale)
timeFrame: Pre and post intervention, approximately 10 minutes
Secondary outcomes:
measure: Post-operative opiate use
timeFrame: Up to 6 months post intervention
measure: Post-operative morphine equivalent dose
timeFrame: Up to 6 months post intervention
measure: Post-operative average daily morphine
timeFrame: Up to 6 months post intervention
measure: Length of stay
timeFrame: Up to 6 months post intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Maryanna Klatt, PhD
role: PRINCIPAL_INVESTIGATOR
References: