Mixed Music Intervention on Sleep Disturbance in Patients With Parkinson's Disease

NCT ID: NCT05489653

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2023-03-29

Brief Summary

Parkinson's disease is a disease that is prevalent in the elderly, and the risk increases with age. Sleep disturbance is a common complaint of patients with Parkinson's disease, with a prevalence of 60% to 96%. Long-term sleep disturbance in Parkinson's disease patients significantly reduces cognitive function and quality of life. Nursing staff are the first line of care and should seek appropriate strategies to address sleep disturbances in patients with Parkinson's disease.

This study is a feasibility and pilot study, which will be a single-blind, parallel randomized controlled trial. It is expected to include 30 patients with Parkinson's disease with poor sleep quality, and they will be equally allocated to the mixed music group (10 people), passive music group (10 people), and usual care group (10 people) in a 1:1:1 ratio. If assigned to the passive music group, they are required to listen to soft and low-pitched music at about 60 beats per minute for 30 minutes before sleep every day for four weeks. If assigned to the mixed music group, in order to synchronize active daytime music and passive music at bedtime, active daytime music will require patients to perform physical music activities once a week and watch a recorded music intervention video three times a week during the study period (The content is the same as the physical music activities) and follow the activities, and the intervention content before going to bed is the same as the intervention content of the pure passive music group. Subjects assigned to the usual care group maintained their original lifestyle and were assisted by study evaluators to complete pre-and post-test data. The researchers will establish a line group, and the three groups of patients or primary caregivers will be contacted by line every two days to care for the patient's condition. The variables measured included anxiety, depression, quality of life, and sleep quality, as assessed by the Hospital Anxiety and Depression Scale, Parkinson 's Disease. Questionnaire - 39, and the Pittsburgh Sleep Quality Scale . This study will use one-way ANOVA and linear mixed model for statistical analysis to test the hypothesis of this study.

If the effectiveness of this intervention can be confirmed, it will be implemented in Parkinson's disease patients in the future to reduce sleep disturbances and improve patients' quality of life.

Detailed Description

Parkinson's disease is a disease that is prevalent in the elderly, and the risk increases with age. Sleep disturbance is a common complaint of patients with Parkinson's disease, with a prevalence of 60% to 96%. Long-term sleep disturbance in Parkinson's disease patients significantly reduce cognitive function and quality of life. Nursing staff are the first line of care and should seek appropriate strategies to address sleep disturbances in patients with Parkinson's disease. In the past, it has been pointed out that passive music therapy can improve sleep disorders, but there is no active music intervention to improve sleep disorders in Parkinson's disease patients, and there is no combination of active and passive music intervention to improve the sleep disorders of this group. Therefore, this study will investigate the effect of active and passive music intervention in improving sleep disturbance in Parkinson's disease patients in a randomized controlled trial.

The purpose of this study was to investigate the effect of active and passive music intervention in improving sleep disturbance in Parkinson's disease patients. This study assumes that active and passive music interventions are feasible intervention measures. Compared with passive music intervention and conventional treatment, active combined passive music intervention is expected to improve the sleep quality and quality of life of patients with Parkinson's disease.

This study is a feasibility and pilot study, which will be a single-blind, parallel randomized controlled trial. It is expected to include 30 Pittsburgh patients with Parkinson's disease with a sleep quality expression of more than 5 points , and they will be equally allocated to the mixed music group (10 people), the pure passive music group (10 people) and conventional treatment in a 1:1:1 ratio. Group (10 people). If assigned to the pure passive music group, they are required to listen to soft and low-pitched music at about 60 beats per minute 30 minutes before bed every day for four weeks. If assigned to the mixed music group, in order to synchronize active daytime music and passive music at bedtime, active daytime music will require patients to perform physical music activities once a week and watch a recorded music intervention video three times a week during the study period (The content is the same as the physical music activities) and follow the activities, and the intervention content before going to bed is the same as the intervention content of the pure passive music group. Subjects assigned to the usual care group maintained their original lifestyle and were assisted by study evaluators to complete pre-and post-test data. The researchers will establish a line group, and the three groups of patients or primary caregivers will be contacted by line every two days to care for the patient's condition. The variables measured included anxiety, depression, quality of life, and sleep quality, as assessed by the Hospital Anxiety and Depression Scale, Parkinson 's Disease. Questionnaire - 39, and the Pittsburgh Sleep Quality Scale . This study will use one-way ANOVA and linear mixed model for statistical analysis to test the hypothesis of this study.

If the effectiveness of this intervention can be confirmed, it will be implemented in Parkinson's disease patients in the future to reduce sleep disturbances and improve patients' quality of life.

Conditions

Music Intervention; Sleep Disturbance; Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

mixed music group

If assigned to the mixed music group, in order to synchronize active daytime music and passive music at bedtime, active daytime music will require patients to perform physical music activities once a week and watch a recorded music intervention video three times a week during the study period (The content is the same as the physical music activities) and follow the activities, and the intervention content before going to bed is the same as the intervention content of the pure passive music group.

Group Type: EXPERIMENTAL

mixed music

Intervention Type: BEHAVIORAL

Learn about the effects of listening to music and doing activities with it on sleep.

pure passive music group

If assigned to the pure passive music group, they are required to listen to soft and low-pitched music at about 60 beats per minute 30 minutes before bed every day for four weeks.

Group Type: ACTIVE_COMPARATOR

mixed music

Intervention Type: BEHAVIORAL

Learn about the effects of listening to music and doing activities with it on sleep.

conventional treatment

Conventional treatment group maintained their original lifestyle and were post-tested with the assistance of a single-blind study evaluator.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mixed music

Learn about the effects of listening to music and doing activities with it on sleep.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The test subjects must be adults or elderly aged 30 to 80 years old, with clear consciousness (Glasgow Coma Scale score 15), no obvious hearing impairment, diagnosed with Parkinson's disease in the first to third stages, Pittsburgh sleep quality expression is more than 5 points, has the ability to move independently with assistance,can communicate in Chinese or Taiwanese, and usually be accompanied by the main caregiver or family members.

Exclusion Criteria

• Exclusions included skeletal injuries or medical orders that restricted or prohibited activities prior to the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202204014

Identifier Type: -

Identifier Source: org_study_id