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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (guided meditation)

Patients listen to 10 minutes of guided meditation prior to surgery.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Listen to guided meditation

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (noise cancelling headphones)

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

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

Wear noise cancelling headphones

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Intervention

Listen to guided meditation

Intervention Type BEHAVIORAL

Behavioral Intervention

Wear noise cancelling headphones

Intervention Type BEHAVIORAL

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No