Symptoms and Signs Involving Cognition Perception Emotion & BehaviourNCT03239587
Investigating the Effect of Simulated Live Piano Music on Preoperative Cancer Patients, Health Care Providers and Hospital Volunteers Using Validated Questionnaires and Proteomic Analysis
An observational study of Symptoms and Signs Involving Cognition Perception Emotion & Behaviour and Abdominal Cancer Patients, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptoms and Signs Involving Cognition Perception Emotion & Behaviour, Abdominal Cancer Patients
- What is being tested?
- Musical Intervention, Blood Draws and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2017to 24 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer participants waiting for surgery at UT MD Anderson Cancer Center.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Symptoms and Signs Involving Cognition Perception Emotion & Behaviour, Abdominal Cancer Patients
- Being tested
- Musical Intervention, Blood Draws, Questionnaires
- Keywords
- Symptoms and signs involving cognition perception emotion & behaviour, Abdominal cancer patients, Musical preop intervention, Surveys, Questionnaires, Blood draws
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical InterventionBehavioural
Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.
Blood DrawsProcedure or surgery
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.
QuestionnairesBehavioural
Also called Surveys
Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood Draws; Behavioral: 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. Receives: Behavioral: Musical Intervention; Procedure: Blood Draws; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start24 Jul 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and Signs Involving Cognition Perception Emotion & BehaviourStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudius Conrad, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239587
- Sponsor's protocol ID
- 2016-0808
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03239587
- Acronym / sponsor ID
- 2016-0808
- Conditions
- Symptoms and Signs Involving Cognition Perception Emotion & Behaviour, Abdominal Cancer Patients
- Keywords
- Symptoms and signs involving cognition perception emotion & behaviour, Abdominal cancer patients, Musical preop intervention, Surveys, Questionnaires, Blood draws
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Musical Intervention - Control Group | – | Procedure: Blood Draws, Behavioral: QuestionnairesParticipants 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. |
| Musical Intervention Group | – | Behavioral: Musical Intervention, Procedure: Blood Draws, Behavioral: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer participants waiting for surgery at UT MD Anderson Cancer Center.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical InterventionParticipants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music. | Behavioural | Musical Intervention Group |
| Blood DrawsNo 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. | Procedure or surgery | Musical Intervention Group, No Musical Intervention - Control Group |
| QuestionnairesAlso: SurveysParticipants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete. | Behavioural | Musical Intervention Group, No Musical Intervention - Control Group |
Primary outcome
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudius Conrad, MD, PHD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Symptoms and Signs Involving Cognition Perception Emotion & Behaviour and Abdominal Cancer Patients, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Defined Musical Intervention on Perceived Stress in Preoperative Cancer Participants (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.