NCT06143826

Brief Summary

Dementia, which leads to deterioration in cognitive and behavioral functions, is a chronic progressive disease. Since the diagnosis is made, the care needs of the patients increase. In the later stages of the disease, it becomes completely dependent on the caregiver. they are coming. Caregiving is performed by family members in developing countries such as Turkey. Family members face many difficulties in their social, work, and daily lives after they start to care. These difficulties are the burden of caregiving is called. Caregivers who perceive the burden of care also experience anxiety, stress, and depression. Jacobson progressive muscle relaxation in coping with these problems exercises can be used. This study was planned to examine the effects of progressive muscle relaxation exercises on anxiety, stress, depression, and caregiver burden in dementia caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

November 11, 2023

Last Update Submit

June 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Caregiver burden

    The Zarit caregiver burden scale will be evaluated before and after the intervention. Five-point Likert-type scale and it consists of 22 statements. The scale has no subgroups. According to the score obtained from the scale: 88-61 points is a severe burden, 60-41 points is moderately severe, 40-21 points is mild to moderate, and less than 21 points is a mild or no burden.

    At the end of the 3 months, the Zarit caregiver burden scale will be applied.

Secondary Outcomes (1)

  • Depression, anxiety and stress

    At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.

Study Arms (1)

Dementia caregiver

EXPERIMENTAL

Caregivers will be asked to perform progressive muscle relaxation exercises 3 days a week for 3 months.

Other: Progressive muscle relaxation exercises

Interventions

Progressive muscle relaxation exercises involve contracting and relaxing 16 muscle groups in the body (hand, upper arm, forearm, forehead, nose, cheek, chin, neck, shoulder, chest, abdomen, waist, stomach, calf, hip, foot). During the exercise, the individual perceives the changes in the muscles during the contraction and relaxation of the muscles. Relaxation exercise is applied along with correct and deep breathing.

Dementia caregiver

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be over 18 years old
  • Being literate
  • Not having difficulties in verbal communication
  • Have been caring for at least 3 months
  • Being able to provide care for free
  • Being the primary caregiver of the patient
  • Not having a psychiatric diagnosis
  • Not using medication for psychiatric illness

You may not qualify if:

  • Providing care for less than 3 months
  • Providing paid care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alzheimer daily life home

Istanbul, 34450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver BurdenDementia

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The research is a pre-test, post-test, cross-sectional, descriptive research.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 11, 2023

First Posted

November 22, 2023

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations