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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01040611
Other study ID # EVA98-13
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 17, 2009
Last updated November 18, 2010
Start date October 2009
Est. completion date September 2010

Study information

Verified date November 2010
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Patient with TB (including patient with drug resistent).

2. Age between 18~65.

3. Conscious Patient without psychiatric/psychological disorders .

4. Patient without Visual, audio disorder.

5. Patient who is able to understand, speak Mandarin and/or Taiwanese, and is able to communicate with written or oral.

Exclusion Criteria:

1. Medical history of psychiatric/psychologic disorder, medication history of anti-anxiety or anti-depressant which might affect mental status.

2. Patient with Visual, audio disorder.

3. Patient who is not comply with 5 day music therapy.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Music therapy
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.

Locations

Country Name City State
Taiwan Taipei Medical University -WanFang Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of music therapy on anxiety, depression and physiological responses 30 minutes Yes
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