An interventional study of mixed music in Music Intervention, Sleep Disturbance and Parkinson's Disease, sponsored by Taipei Medical University. Terminated at 1 site in Taiwan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention
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.
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.
769 studies on the registry are indexed under Parasomnias; 187 are open to participants now.
This study's enrollment of 10 is below the median of 66 across 579 interventional studies indexed under Parasomnias.
Browse Parasomnias studies →Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: mixed music
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.
Behavioral: mixed music
Conventional treatment group maintained their original lifestyle and were post-tested with the assistance of a single-blind study evaluator.
Learn about the effects of listening to music and doing activities with it on sleep.
Pittsburgh Sleep Quality Index
Sleep quality will be assessed by the Chinese version of the Pittsburgh Sleep Quality Scale, which is divided into subjective sleep quality, sleep quality and sleep quality. Lag period, total sleep hours, habitual sleep efficiency, sleep disturbance, sleep medication use, and daytime functional status. The total Pittsburgh sleep quality index is the total score of the seven major parts, so the total score is up to 21 points. If the total score is more than 5 points, it means sleep The quality is not good; on the contrary, the total score is ≤ 5 points, which means the sleep quality is good. Chinese version of Pittsburgh Sleep Quality Scale Internal Consistency (Cronbach's alpha) ranged from 0.82 to 0.83, with a sensitivity and specificity of 98% and 55%. Therefore, the scale is an accurate and reliable assessment tool.
Time frame: four-week intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Mar 2023, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.