The Effect of Music in Alzheimer's Patients
The Effect of Music on Decreasing of Adaptation Difficulty in Alzheimer's Patients: Randomized Controlled Study
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Apr 2018
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedNovember 18, 2021
November 1, 2021
3 months
October 22, 2021
November 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment Scale of Adaptation Difficulty for Elderly
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.
24 days
Study Arms (2)
Experimental group
EXPERIMENTALBefore 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 .
Control group
NO INTERVENTIONNo intervention was performed for the patients in the control group.
Interventions
Eligibility Criteria
You may qualify if:
- age range
- Were conscious able to communicate and active
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
October 22, 2021
First Posted
November 18, 2021
Study Start
April 16, 2018
Primary Completion
July 13, 2018
Study Completion
July 13, 2018
Last Updated
November 18, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share