NCT06687486

Brief Summary

Caregivers are also faced with multiple stress factors. Autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. Although there are various studies on this subject (Chegeni et al. 2018, Seo and Kim 2019, Ramiraz-Garcia et al. 2020, Wang et al. 2021, Bagheri et all 2021, Ozhanlı and Akyuz 2022), there is no study on caregivers as far as we could reach. As a result of this study, nurses will help caregivers, whom they work one-on-one in most areas, to relax, thus helping to increase the quality of patient care in home environments and contributing to the increase in the quality of life of the caregiver. Thus, caregivers will be able to manage care more actively and effectively both at home and in clinics. Based on this purpose, the aim of the study is to reduce the anxiety level of caregivers, increase the quality of life and reduce the burden of care after autogenic relaxation therapy to be applied to caregivers.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

November 7, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

November 13, 2024

Status Verified

June 1, 2024

Enrollment Period

23 days

First QC Date

November 7, 2024

Last Update Submit

November 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Principial

    A decrease in the perceived stress scale score indicates a decrease in stress, an increase in the quality of life scale score indicates an increase in the quality of life, and a decrease in the care burden scale score indicates a decrease in the care burden. The secondary outcome measure is the decrease in the Perceived Stress Scale score, the increase in the Quality of Life Scale Score, and the decrease in the care burden scale score after autogenic relaxation therapy applied to caregivers.

    1 month

Secondary Outcomes (1)

  • second

    3 month

Study Arms (2)

intervention

EXPERIMENTAL
Behavioral: relaxin

control

OTHER
Other: kontrol

Interventions

relaxinBEHAVIORAL

caregivers relaxing and care burden

intervention
kontrolOTHER

no intervention

control

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Being able to answer data collection forms
  • Being able to speak Turkish
  • Being able to provide continuous or partial care to a patient for at least 3 months
  • Being able to communicate

You may not qualify if:

  • Having epilepsy
  • Not speaking or understanding Turkish
  • Having a neurological disability
  • Having had an acute myocardial infarction
  • Being diagnosed with schizophrenia and major depression
  • Being addicted to alcohol or drugs
  • Having a history of loss of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversitesi

Konya, 42450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Relaxin

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Corpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Individuals assigned as intervention and control will complete the research in these groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 13, 2024

Study Start

November 7, 2024

Primary Completion

November 30, 2024

Study Completion

February 20, 2025

Last Updated

November 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations