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The Effect of Music in Alzheimer's Patients

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music therapy
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer's disease, Music, Adaptation difficulty, Nursing care

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eskisehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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 .

No intervention was performed for the patients in the control group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2021
Last Updated
November 8, 2021
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05125536
Brief Title
The Effect of Music in Alzheimer's Patients
Official Title
The Effect of Music on Decreasing of Adaptation Difficulty in Alzheimer's Patients: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
July 13, 2018 (Actual)
Study Completion Date
July 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Adaptation levels of Alzheimer's patients should be determined before planning nursing interventions. Institutions should support healthcare personnel in organizing music sessions for patients. It is believed that further studies examining the effect of the Nihavent theme in decreasing adaptation difficulty in Alzheimer's patients should be conducted with larger sample groups. The effects of verbal and non-verbal music on Alzheimer's patients should also be evaluated and compared to gain further insight on this important matter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, Music, Adaptation difficulty, Nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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 .
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention was performed for the patients in the control group.
Intervention Type
Other
Intervention Name(s)
Music therapy
Other Intervention Name(s)
rutin
Intervention Description
rutin
Primary Outcome Measure Information:
Title
Assessment Scale of Adaptation Difficulty for Elderly
Description
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.
Time Frame
24 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
State/Province
Odunpazarı
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Music in Alzheimer's Patients

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