Preoperative Guided Imagery in Patients Undergoing Urologic Surgery

University of California San Francisco (UCSF)

Status: Completed

Conditions: Urologic Cancer

Treatments: Behavioral: Guided Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT05072639

NCI-2021-10906 (Registry Identifier)

15989

Details and patient eligibility

About

This is a prospective randomized controlled trial of patients undergoing major urologic-oncologic surgery at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center. This clinical trial examines the effect of guided meditation before surgery on the levels of anxiety, stress, sleep disturbance, and quality of life among patients scheduled to undergo a major urologic surgery for cancer. A cancer diagnosis and the treatments associated with it can be very stressful for patients, leading to depression, sleep disturbances, and lower quality of life. Mind-body practices such as guided meditation have been used for thousands of years to reduce the effects of chronic stress and to improve quality of life. This clinical trial examines the effects of guided meditation on the stress, depression, and quality of life levels of patients undergoing urologic surgery for their cancer.

Full description

PRIMARY OBJECTIVE:

I. To determine the effect of 14 days of preoperative guided visualization meditation on patients' anxiety undergoing major urologic-oncology surgery.

SECONDARY OBJECTIVES:

I. To determine the effect of preoperative guided visualization meditation on patients' depression, stress, and quality of life.

II. To examine the difference in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey question scores between the two study groups.

III. To determine the ability of patient to perform a daily 23 minute meditation.

IV. To examine the correlation between depression and emergency department (ED) visits and readmissions post-operations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients listen to guided meditation over 23 minutes daily for two weeks before their standard of care surgery. Patients also complete surveys over 10-15 minutes at baseline, after 10 days, 1 day before standard of care surgery, the day after discharge, and then 4 weeks after surgery.

ARM 2: Patients complete surveys over 10-15 minutes at baseline, after 10 days, 1 day before standard of care surgery, the day after discharge, and then 4 weeks after surgery.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age.
• Patients undergoing radical cystectomy, radical or partial nephrectomy, or radical prostatectomy at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center
• Access to an electronic device that can play mp3 recording and for survey completion
• At least a 2 week window from date of surgical booking to the scheduled surgery

Exclusion criteria

• Inability to consent for the study (ie, they have a surrogate decision maker).
• Non-English speaker (the meditations are only available in English)
• Patients scheduled for surgery less than 2 weeks away

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Meditation

Experimental group

Description:

Participants randomized to the meditation arm will receive an mp3 audio recording of the visual guided meditation will be sent an additional mp3 file specifically for the recovery phase of surgery. Participants will be asked to complete a series of pre-study questionnaires to determine their baseline anxiety, depression, stress, and quality of life scores. Subjects will then complete the same questionnaires at four additional time points: after 10 days of daily meditations, 1 day before their surgery, and day after discharge, and 4 weeks post-operation.

Treatment:

Behavioral: Guided Meditation

Control group

No Intervention group

Description:

Participants received standard of care, including the option to attend a free "Prepare for Surgery workshop". Participants will be asked to complete a series of pre-study questionnaires to determine their baseline anxiety, depression, stress, and quality of life scores. Subjects will then complete the same questionnaires at four additional time points: after 10 days of daily meditations, 1 day before their surgery, and day after discharge, and 4 weeks post-operation.