Mental Stress Symptoms in Family Caregivers of Palliative Patients

Receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. New perspectives often arise, as well as feelings of worry, sadness and powerlessness. Caregiving is often an extreme physical challenge, but above all a psychological one.

Aims of the study

1. To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.
2. To investigate whether family caregivers of palliative patients with increased stress levels and burnout-promoting work-related behaviour suffer more from burnout symptoms, health-related anxiety and psychosomatic complaints.
3. To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.

Study Overview

• Status: Recruiting
• Conditions: Family Caregivers; Palliative Patients
• Intervention / Treatment: Other: psychometric questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Andreas Baranyi, MD; Phone Number: 004331638586241; Email: an.baranyi@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz
    • Contact: Andreas Baranyi, M.D.; Phone Number: 0043-316-385-86241; Email: an.baranyi@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Family caregivers of palliative patients

Description

Inclusion criteria:

• Women and men between 18 and 90 years of age
• Current palliative care situation of a relative with a life-limiting diagnosis.

Exclusion criteria:

• Persons incapable of giving consent (e.g. dementia, delirium, etc.)
• Failure to meet the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
family caregivers of palliative patients; psychometric questionnaires	Other: psychometric questionnaires; Perceived Stress Scale (PSS-10); Trier-Inventory on Chronic Stress; State/Trait Anxiety Inventory (STAI); AVEM-Work-related behaviour and experience pattern; Maslach Burn-out Inventory - Human Services Survey (MBI - HSS) health-related anxiety: Whiteley Index (WI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
burn-out syndrome, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)	Maslach Burn-out Inventory (MBI), The MBI does not provide a single score but a profile.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health-related anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)	Whiteley Index/Illness Attitude Scale (WI-IAS). Whitely-Index: The Whitely-Index is formed by the sum of the points for each answer - the higher the score, the more likely one is to be hypochondriacal. IAS: The total score ranges from 0 to108.	2 months
State/Trait anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)	State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores correlating with greater anxiety.	2 months
Work-related behaviour and experience pattern, Outcome is the difference between measurement 1 (Baseline) and measurement 2.	Work-related behaviour and experience pattern (AVEM), The AVEM questionnaire does not provide a single score but a profile.	2 months

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Andreas Baranyi, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 33-332 (Other Identifier: Ethikkommission Medizinische Universität Graz)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No