Mental Stress Symptoms in Family Caregivers of Palliative Patients

Family Caregivers Clinical Trial

Official title:

Mental Stress Symptoms in Family Caregivers of Palliative Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054647
• Other study ID #: 33-332
• Secondary ID: 33-332
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: Andreas Baranyi, MD
• Phone: 004331638586241
• Email: an.baranyi[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Family Caregivers
• Palliative Patients
• Stress, Psychological

Intervention

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)

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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