NCT05125536

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

October 22, 2021

Last Update Submit

November 8, 2021

Conditions

Keywords

Alzheimer's diseaseMusicAdaptation difficultyNursing care

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

EXPERIMENTAL

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 .

Other: Music therapy

Control group

NO INTERVENTION

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

Interventions

rutin

Also known as: rutin
Experimental group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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)

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Music TherapyRutin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesFlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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

Locations