NCT05596877

Brief Summary

This study explores the effects of music therapy intervention on anxiety and time perception during pulmonary rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2023

Completed
Last Updated

April 10, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

October 24, 2022

Last Update Submit

April 7, 2023

Conditions

Chronic Pulmonary Disease

Keywords

Music therapyPulmonary rehabilitationDepressionPercieved timeChronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

  • 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)

    25 minutes

Secondary Outcomes (2)

  • Respiratory rate

    25 minutes

  • Heart rate variability

    25 minutes

Study Arms (2)

Control Group

NO INTERVENTION

Recieved pulmonary rehabilitation

Intervention Group

EXPERIMENTAL

Recieved pulmonary rehabilitation with music therapy

Behavioral: Music therapy

Interventions

Music therapyBEHAVIORAL

Performing music therapy during a course of pulmonary rehabilitation (25 mins)

Intervention Group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recieved pulmonary rehabilitation at least three months
  • Recieved a negative ventilation during a pulmonary rehabilitation
  • A written informed consent

You may not qualify if:

  • impaired of hearing
  • decline to participate
  • cognitive communication deficits
  • acute exacerbation of copd within three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location

MeSH Terms

Conditions

DepressionPulmonary Disease, Chronic Obstructive

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

November 21, 2022

Primary Completion

February 11, 2023

Study Completion

February 11, 2023

Last Updated

April 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)