- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040611
Effectiveness of Music Therapy (TMT)
November 18, 2010 updated by: Taipei Medical University WanFang Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- Taipei Medical University -WanFang Hospital
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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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music therapy
This study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis.
|
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.
|
|
No Intervention: Placebo
No music therapy apply to this arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effectiveness of music therapy on anxiety, depression and physiological responses
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
October 1, 2009
Primary Completion (Anticipated)
September 1, 2010
Study Completion (Anticipated)
September 1, 2010
Study Registration Dates
First Submitted
November 17, 2009
First Submitted That Met QC Criteria
December 28, 2009
First Posted (Estimate)
December 29, 2009
Study Record Updates
Last Update Posted (Estimate)
November 19, 2010
Last Update Submitted That Met QC Criteria
November 18, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVA98-13
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.