NCT04368780

Brief Summary

The increase in the elderly population, insufficiencies in chronic diseases cause an increase in the number of dependent and dependent elderly. This situation negatively affects caregivers with elderly individuals. nonpharmacological interventions are commonly used to reduce the negative emotions of caregivers due to care. One of these applications is progressive relaxation exercises. This study was planned in a randomized controlled experimental study design to investigate the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers who care for bed dependent elderly individuals. The study will consist of 10 interventions, 10 control groups, and 20 caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

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 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

April 27, 2020

Last Update Submit

February 16, 2022

Conditions

Keywords

caregiverolder peopledepressionprogressive muscle relaxation

Outcome Measures

Primary Outcomes (1)

  • the Carer's Assessment of Satisfaction Index

    The caregivers measure satisfaction with care.

    2 months

Secondary Outcomes (2)

  • the Zarit Caregiver Burden Scale

    2 months

  • the Beck Depression Scale

    2 months

Study Arms (2)

Control group

NO INTERVENTION

Individuals who provide home care to an elderly person who is dependent on the bed

Experimental group

EXPERIMENTAL

Individuals who provide home care to an elderly person who is dependent on the bed. It is planned that the exercises will be conducted two days a week with the researcher and on the other days by the caregiver herself for a total of eight weeks.

Other: Effect of Progressive Muscle Relaxation Combined With Music

Interventions

The CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 30-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The age of the caregiver is 18 years old.
  • Giving care to the elderly patient who is dependent on the bed for at least 3 months and above,
  • No psychiatric disease diagnosed,
  • No vision, speech or hearing problems that would prevent the information given from being understood and the implementation of PMR exercise,
  • Individuals providing voluntary care will be included in participating in the research.

You may not qualify if:

  • The age of the caregiver under 18
  • Giving care to an elderly person dependent on bed for less than 3 months
  • With a diagnosis of psychiatric illness
  • Has a vision, speech or hearing problem that will prevent the information given from being understood and the implementation of the PMR exercise,
  • Caregivers who do not agree to participate in the research will not be included in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aksaray University Faculty of Health Science

Aksaray, 68100, Turkey (Türkiye)

Location

Aksaray University Health Science Faculty

Aksaray, 68100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No Intervention: Control group Experimental: Experimental group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
2019/24

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

March 15, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

We have no plans.

Locations