TuberculosisTMTNCT01040611
Effectiveness of Music Therapy
A study testing Music therapy in people with Tuberculosis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long period, admission to negative pressure isolation wards, and restrictions on visitors. During the in-patient admission, patients are vulnerable to social isolation and separation anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Sep 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with TB (including patient with drug resistent).
- Age between 18~65.
- Conscious Patient without psychiatric/psychological disorders .
- Patient without Visual, audio disorder.
- Patient who is able to understand, speak Mandarin and/or Taiwanese, and is able to communicate with written or oral.
Who cannot join
- Medical history of psychiatric/psychologic disorder, medication history of anti-anxiety or anti-depressant which might affect mental status.
- Patient with Visual, audio disorder.
- Patient who is not comply with 5 day music therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Music Therapy on Anxiety, Depression and Physiological Responses for Inpatients of Tuberculosis
Tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long period, admission to negative pressure isolation wards, and restrictions on visitors. During the in-patient admission, patients are vulnerable to social isolation and separation anxiety. If anxiety sustained, patients' quality of life would be affected. Thus, it is important to improve patients' experience of anxiety. Music has the effectiveness of relaxation, and is helpful to patients' anxious status and physiological responses. This study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis.
Read the detailed description
The experimental study was conducted on a medical center of North Taiwan. 66 patients with Tuberculosis were included in this study. Patients who fit the inclusion criteria were randomly assigned to either experimental or control group. Patients in experimental group could choose a piece of CD and listen to music with earphone for 30 minutes. Patients in control group just rest for 30 minutes. The procedure was implemented once a day, and sustained for total 5 days.
- Conditions
- Tuberculosis
- Being tested
- Music therapy
- Keywords
- music therapy, Tuberculosis, anxiety, physiological response
- Medical subject headings
- Tuberculosis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Patients who fit the inclusion criteria were random assigned to either experimental or control group. Patients in experimental group could choose a piece of CD and listen to music with earphone for 30 minutes. Patients in control group just rest for 30 minutes. The procedure was implemented once a day, and sustained for total 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Experimental | This study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis. Receives: Behavioral: Music therapy |
| Placebo | No intervention | No music therapy apply to this arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of music therapy on anxiety, depression and physiological responses
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040611
- Sponsor's protocol ID
- EVA98-13
- Acronym
- TMT
- Status last verified
- Nov 2010
- First submitted
- 17 Nov 2009
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Music Therapy on Anxiety, Depression and Physiological Responses for Inpatients of Tuberculosis
- ClinicalTrials.gov ID
- NCT01040611
- Acronym / sponsor ID
- TMT / EVA98-13
- Conditions
- Tuberculosis
- Keywords
- music therapy, Tuberculosis, anxiety, physiological response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 29 Dec 2009 (estimated)
- 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.
Tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long period, admission to negative pressure isolation wards, and restrictions on visitors. During the in-patient admission, patients are vulnerable to social isolation and separation anxiety. If anxiety sustained, patients' quality of life would be affected. Thus, it is important to improve patients' experience of anxiety. Music has the effectiveness of relaxation, and is helpful to patients' anxious status and physiological responses. This study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis.
Detailed description
The experimental study was conducted on a medical center of North Taiwan. 66 patients with Tuberculosis were included in this study. Patients who fit the inclusion criteria were randomly assigned to either experimental or control group. Patients in experimental group could choose a piece of CD and listen to music with earphone for 30 minutes. Patients in control group just rest for 30 minutes. The procedure was implemented once a day, and sustained for total 5 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Behavioral: Music therapyThis study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis. |
| Placebo | No intervention | –No music therapy apply to this arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with TB (including patient with drug resistent).
- Age between 18~65.
- Conscious Patient without psychiatric/psychological disorders .
- Patient without Visual, audio disorder.
- Patient who is able to understand, speak Mandarin and/or Taiwanese, and is able to communicate with written or oral.
Key exclusion criteria (3 listed)
- Medical history of psychiatric/psychologic disorder, medication history of anti-anxiety or anti-depressant which might affect mental status.
- Patient with Visual, audio disorder.
- Patient who is not comply with 5 day music 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 |
|---|---|---|
| Music therapyPatients who fit the inclusion criteria were random assigned to either experimental or control group. Patients in experimental group could choose a piece of CD and listen to music with earphone for 30 minutes. Patients in control group just rest for 30 minutes. The procedure was implemented once a day, and sustained for total 5 days. | Behavioural | Music therapy |
Primary outcome
Effectiveness of music therapy on anxiety, depression and physiological responses
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy in people with Tuberculosis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Nov 2010. 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 Taiwan. 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?
Results are not available in the source record.
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?
Effectiveness of music therapy on anxiety, depression and physiological responses (time frame: 30 minutes). 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 19 Nov 2010.