AnxietyNCT03527225
Music of Choice to Decrease Anxiety During Radiation Treatment
A study testing Music in people with Anxiety and Cancer, run by University of Florida at 1 site in United States.
Trial summary
The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 15 Jan 2020
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to receive radiotherapy for malignant tumor
- ECOG Performance Status 0-4
- Fluent in English Language
- Inclusion in this study will not be based on race or ethnicity
- Patients must be deemed able to comply with the treatment plan.
- Patients must provide study specific informed consent prior to study entry.
Who cannot join
- Prior history of radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health Cancer Center
Gainesville, Florida, 32608
About this study
Official title: A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer
The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.
Read the detailed description
Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.
- Being tested
- Music
- Keywords
- Music Therapy, First Radiotherapy, Anxiety Reduction, Psychosocial Functioning, State - Trait Anxiety Inventory (STAI), Symptom Distress Thermometer (SDT)
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource. Receives: Other: Music |
| No Music | No intervention | These patient's will have no music playing during the first radiotherapy session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety.
Measured: baseline
Secondary outcomes (5)
Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress.
Measured: baseline
Magnitude change of STAI Score
The magnitude of change in anxiety score of STAI in "high anxiety" patients (pre-treatment STAI ≥ 40) as a result of listening to music during the first radiotherapy session.
Measured: baseline
Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
The magnitude of change in anxiety score of SDT in "high anxiety" patients (pre-treatment SDT ≥ 4) as a result of listening to music during the first radiotherapy session. Scale of 0 - 10; with 10 being clinically significant distress.
Measured: baseline
STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using STAI scores. A score of 39-40 on each subset suggests clinically significant anxiety.
Measured: baseline
SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using SDT scores. Scale of 0 - 10; with 10 being clinically significant distress.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start22 Jan 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consented, eligible female subjects to be randomized to "Music" or "No Music" to evaluate pre and post treatment anxiety level via STAI and SDT anxiety questionnaire at their first radiotherapy treatment for cancer.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie A. Lockney, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527225
- Sponsor's protocol ID
- IRB201703352
- Other IDs
- OCR17059
- Status last verified
- Mar 2020
- First submitted
- 4 May 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer
- ClinicalTrials.gov ID
- NCT03527225
- Acronym / sponsor ID
- IRB201703352
- Keywords
- Music Therapy, First Radiotherapy, Anxiety Reduction, Psychosocial Functioning, State - Trait Anxiety Inventory (STAI), Symptom Distress Thermometer (SDT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 17 May 2018 (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 primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.
Detailed description
Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consented, eligible female subjects to be randomized to "Music" or "No Music" to evaluate pre and post treatment anxiety level via STAI and SDT anxiety questionnaire at their first radiotherapy treatment for cancer.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicPatients randomized to the music intervention arm will select a preferred genre of music from an internet based resource. |
| No Music | No intervention | –These patient's will have no music playing during the first radiotherapy session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to receive radiotherapy for malignant tumor
- ECOG Performance Status 0-4
- Fluent in English Language
- Inclusion in this study will not be based on race or ethnicity
- Patients must be deemed able to comply with the treatment plan.
Key exclusion criteria (1 listed)
- Prior history of radiation therapy
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 |
|---|---|---|
| MusicThe patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded. | Other | Music |
Primary outcome
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Time frame: baseline
Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety.
5 secondary outcomes
Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Time frame: baseline
Magnitude change of STAI Score
Time frame: baseline
Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Time frame: baseline
STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
Time frame: baseline
SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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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.
Natalie A. Lockney, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Anxiety and Cancer, run by University of Florida at 1 site in United States.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session. (time frame: baseline). 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 13 Mar 2020.