Investigating the Effect of Simulated Live Piano Music on Preoperative Cancer Patients, Health Care Providers and Hospital Volunteers Using Validated Questionnaires and Proteomic Analysis

August 11, 2023 updated by: M.D. Anderson Cancer Center

Investigating the Effect of Simulated Live Piano Music on Preoperative Cancer Patients, Health Care Providers and Hospital Volunteers Using Validated Questionnaires, Proteomic Analysis, and Neuroimaging

The goal of this research study is to learn if simulated live piano music can change the amount of stress felt in patients with cancer before surgery, health care providers caring for cancer patients, and/or hospital volunteers.

This is an investigational study.

Up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be enrolled in this study. All will take part at MD Anderson.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. Participants in the first group will wait for 30 minutes in a standard pre-surgery waiting area without music. Participants in the other group will go to a waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

A Steinway Spirio grand piano is a special type of piano that plays music by itself (also called a player piano). The music will be chosen by the study staff and pre-recorded on the piano. Although the keys will move on the piano as if someone is playing the piano, you will be alone in the room.

You will have an equal chance (50/50) of being assigned to either group. Both you and the person in charge of this study will know to which group you have been assigned. You do not get to choose which group you are in.

Study Procedures:

Before and about 30 minutes after you either listen to music or stand in the waiting room without music:

  • Blood (about 1½ teaspoons each time) will be drawn to learn how your body is responding to the music or silence by measuring the amount of cortisol in your body (a type of hormone related to stress) and for biomarker testing. Biomarkers are found in the blood and may be related to your reaction to the music or silence. If you are a healthcare provider or volunteer, you will not have these blood draws.
  • You will complete 2 questionnaires about your anxiety and stress levels. It should take about 20-30 minutes to complete.

Length of Study:

You participation on this study will be over after the last blood draw and questionnaire are completed.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer participants waiting for surgery at UT MD Anderson Cancer Center.

Description

Inclusion Criteria:

1) Patients: To preserve a homogenous cohort and comply with the departmentally-organized research infrastructure, we will include pPreoperative abdominal cancer patients undergoing surgery, or healthcare provider from all specialties at MDACC or volunteer from MDACC Volunteer Service.

Exclusion Criteria:

  1. Cannot give informed consent
  2. Are deaf or hearing-disabled
  3. Less than 18 years in age
  4. Profess extreme dislike of music.
  5. Wait time is longer than 240 min.
  6. Underlying structural brain abnormality or neurologic comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Musical Intervention - Control Group

Participants wait for 30 minutes in a standard pre-surgery waiting area without music.

Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.

Participants complete 2 questionnaires about anxiety and stress levels.
Procedure: Blood Draws

No Musical Intervention - Control Group: Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.

Musical Intervention Group: Blood drawn before, and about 30 minutes after in waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

Behavioral: Questionnaires
Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.
Other Names:
  • Surveys
Musical Intervention Group

Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

Blood drawn before, and about 30 minutes after participant in the waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

Participants complete 2 questionnaires about anxiety and stress levels.
Procedure: Blood Draws

No Musical Intervention - Control Group: Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.

Musical Intervention Group: Blood drawn before, and about 30 minutes after in waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

Behavioral: Questionnaires
Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.
Other Names:
  • Surveys
Behavioral: Musical Intervention
Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Defined Musical Intervention on Perceived Stress in Preoperative Cancer Participants
Time Frame: 1 day
Effect of defined musical intervention on perceived stress measured by the Spielberger State-Trait Anxiety Inventory (STAI-S).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Claudius Conrad, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Actual)

April 24, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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