Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed 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: Behavioral Intervention, Behavioral Intervention, Electronic Health Record Review, Survey Administration.
- Who it may be relevant to
- Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. 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
Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety
Overview
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.
Interventions
- Behavioral Behavioral Intervention
Listen to guided meditation - Behavioral Behavioral Intervention
Wear noise cancelling headphones - Other Electronic Health Record Review
Ancillary studies - Other Survey Administration
Ancillary studies
Primary outcome measures
- Pre-operative anxiety (PROMIS Anxiety scale) [Time frame: Pre and post intervention, approximately 10 minutes]
- Pre-operative anxiety (single-item visual analog scale) [Time frame: Pre and post intervention, approximately 10 minutes]
Secondary outcome measures (4)
- Post-operative opiate use [Time frame: Up to 6 months post intervention]
- Post-operative morphine equivalent dose [Time frame: Up to 6 months post intervention]
- Post-operative average daily morphine [Time frame: Up to 6 months post intervention]
- Length of stay [Time frame: Up to 6 months post intervention]
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
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
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT06949943 · OSU-24146 · NCI-2025-01389