NCT03239587

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

August 2, 2017

Last Update Submit

August 11, 2023

Conditions

Symptoms and Signs Involving Cognition Perception Emotion & BehaviourAbdominal Cancer Patients

Keywords

Symptoms and signs involving cognition perception emotion & behaviourAbdominal cancer patientsMusical preop interventionSurveysQuestionnairesBlood draws

Outcome Measures

Primary Outcomes (1)

  • Effect of Defined Musical Intervention on Perceived Stress in Preoperative Cancer Participants

    Effect of defined musical intervention on perceived stress measured by the Spielberger State-Trait Anxiety Inventory (STAI-S).

    1 day

Study Arms (2)

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 DrawsBehavioral: Questionnaires

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.

Behavioral: Musical InterventionProcedure: Blood DrawsBehavioral: Questionnaires

Interventions

Musical InterventionBEHAVIORAL

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

Musical Intervention Group
Blood DrawsPROCEDURE

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.

Musical Intervention GroupNo Musical Intervention - Control Group
QuestionnairesBEHAVIORAL

Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.

Also known as: Surveys
Musical Intervention GroupNo Musical Intervention - Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \) 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood (about 1½ teaspoons each time) drawn before and about 30 minutes after participant either listens to music or stands in the waiting room without music.

MeSH Terms

Conditions

Behavior

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Claudius Conrad, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 4, 2017

Study Start

July 24, 2017

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

August 14, 2023

Record last verified: 2023-08