- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125536
The Effect of Music in Alzheimer's Patients
The Effect of Music on Decreasing of Adaptation Difficulty in Alzheimer's Patients: Randomized Controlled Study
This study was randomized controlled study conducted to determine the effect of Nihavent theme on reducing adjustment difficulties in Alzheimer's patients.
The study was carried out with 30 patients.15 patients constituted the experimental group and 15 patients formed the control group. Before the application, the scale was administered to both groups through face-to-face interviews. The patients in the experimental group were informed about the music session in advance.Instrumental songs in nihavent theme were played with the sound system to the experimental group. The sessions were lasted 12 weeks in total and there were two sessions per week, and each session took approximately 50 minutes to complete. While no intervention was performed for the patients in the control group. One week after the last music session, the the scale was re-administered to both groups.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Odunpazarı
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Eskisehir, Odunpazarı, Turkey, 26040
- Eskisehir Osmangazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-90 age range
- Were conscious able to communicate and active
Exclusion Criteria:
- Change in their diagnosis, medications, consciousness, and/or drug dose
- During the study period they a regression in emotional state (crying, sadness)
- Those with complex diseases such as cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Before the application, the "Descriptive Characteristics Data Form" and "Assessment Scale of Adaptation Difficulty in Elderly" were administered to the experimental group by the investigator through face-to-face interviews.
A cd containing songs in Nihavent theme (instrumental), computer and sound system were used during the application.
The patients in the experimental group were informed about the music session in advance.
The sessions lasted 12 weeks in total and there were two sessions per week (Monday and Wednesday), and each session took approximately 50 minutes to complete.
One week after the last music session (end of 12th week), the "Assessment Scale of Adaptation Difficulty in the Elderly" was re-administeredto the experimental group .
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rutin
Other Names:
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No Intervention: Control group
No intervention was performed for the patients in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment Scale of Adaptation Difficulty for Elderly
Time Frame: 24 days
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This scale was developed by Şişman et al. in 2016 in order to determine the adaptation of elderly individuals, and its validity and reliability were determined.
Chronbach alpha internal consistency coefficient was found to be 0.93.
It is a likert-type scale consisting of 24 questions.
The answers to each item were determined as 0 points for "never", 1 point for "some", 2 points for "quite a lot" and 3 points for "a lot".
The scores obtained from the items in the scoring of the scale are calculated by summing and dividing by the number of questions.
The average score that can be obtained from the scale is 0 points as the lowest and 3 points at the highest.
As the individual's score from the scale decreases, the level of compliance increases.
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24 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHMUGAE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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