Music Therapy in Pulmonary Rehabilitation
Primary Purpose
Chronic Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Music therapy
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pulmonary Disease focused on measuring Music therapy, Pulmonary rehabilitation, Depression, Percieved time, Chronic obstructive pulmonary disease
Eligibility Criteria
Inclusion Criteria:
- Recieved pulmonary rehabilitation at least three months
- Recieved a negative ventilation during a pulmonary rehabilitation
- A written informed consent
Exclusion Criteria:
- impaired of hearing
- decline to participate
- cognitive communication deficits
- acute exacerbation of copd within three months
Sites / Locations
- Fu Jen Catholic University Hospital, Fu Jen Catholic University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Recieved pulmonary rehabilitation
Recieved pulmonary rehabilitation with music therapy
Outcomes
Primary Outcome Measures
Beck Anxiety Inventory's score
Beck Anxiety Inventory's score (0 present as minimal and 63 present as maximal, higher scores mean a worse outcome)
Secondary Outcome Measures
Respiratory rate
Respiratory rate during a course of pulmonary rehabilitation
Heart rate variability
Heart rate variability during a course of pulmonary rehabilitation
Full Information
NCT ID
NCT05596877
First Posted
October 24, 2022
Last Updated
April 7, 2023
Sponsor
Fu Jen Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT05596877
Brief Title
Music Therapy in Pulmonary Rehabilitation
Official Title
The Effect of Music Therapy on Anxiety and Perceived Time in Pulmonary Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
February 11, 2023 (Actual)
Study Completion Date
February 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study explores the effects of music therapy intervention on anxiety and time perception during pulmonary rehabilitation.
Detailed Description
Background:
In recent years, in many domestic and foreign music therapy literature, it can be found that the intervention of music therapy can alleviate the anxiety of patients in the treatment, surgery, and even patients with critical care using ventilators, and then affect the patient's physiological indicators, in addition, there are also studies that mention that background music affects people's waiting time perception, reduces people's waiting time, can reduce the generation of negative emotions, and improve the quality of hospital medical care. The objective of this study was to explore the effects of music therapy on anxiety and time perception during pulmonary rehabilitation.
Study Design:
This case is a one-year single-center, prospective block randomizied trial.
Methods:
The study is expected to be 50 people, randomly assigned to two groups (control group, experimental group) will be carried out in the pulmonary rehabilitation room on the sixth floor of the Fu Jen Catholic University Hospital, using the Baker Anxiety Scale, physiological monitoring instruments and cardiac output monitor as tools to test the effects of anxiety sensations, physiological responses (heartbeat, breathing times, blood pressure, heart rate variability) and perceptual time in two situations of interventional music therapy and non-interventional music therapy during the rehabilitation of negative pressure respirators.
Effect:
It was mainly found that the intervention of music therapy can reduce anxiety, number of heartbeats, number of breaths and blood pressure, and shorten the perceptual time of patients with pulmonary rehabilitation.
Key words:
Music therapy; pulmonary rehabilitation; depression; percieved time; chronic obstructive pulmonary disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pulmonary Disease
Keywords
Music therapy, Pulmonary rehabilitation, Depression, Percieved time, Chronic obstructive pulmonary disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Recieved pulmonary rehabilitation
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Recieved pulmonary rehabilitation with music therapy
Intervention Type
Behavioral
Intervention Name(s)
Music therapy
Intervention Description
Performing music therapy during a course of pulmonary rehabilitation (25 mins)
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory's score
Description
Beck Anxiety Inventory's score (0 present as minimal and 63 present as maximal, higher scores mean a worse outcome)
Time Frame
25 minutes
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
Respiratory rate during a course of pulmonary rehabilitation
Time Frame
25 minutes
Title
Heart rate variability
Description
Heart rate variability during a course of pulmonary rehabilitation
Time Frame
25 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recieved pulmonary rehabilitation at least three months
Recieved a negative ventilation during a pulmonary rehabilitation
A written informed consent
Exclusion Criteria:
impaired of hearing
decline to participate
cognitive communication deficits
acute exacerbation of copd within three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, PhD
Organizational Affiliation
Fu Jen Catholic University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fu Jen Catholic University Hospital, Fu Jen Catholic University
City
New Taipei City
ZIP/Postal Code
24352
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Music Therapy in Pulmonary Rehabilitation
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