NCT01040611

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

11 months

First QC Date

November 17, 2009

Last Update Submit

November 18, 2010

Conditions

Keywords

music therapyTuberculosisanxietyphysiological response

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of music therapy on anxiety, depression and physiological responses

    30 minutes

Study Arms (2)

Music therapy

EXPERIMENTAL

This study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis.

Behavioral: Music therapy

Placebo

NO INTERVENTION

No music therapy apply to this arm

Interventions

Music therapyBEHAVIORAL

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.

Music therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University -WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

TuberculosisAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

December 29, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations