Clinical trial NCT05703165: Horse-assisted Intervention, Heart Rate Variability & Stress
Official title: Horse-assisted Intervention and Heart Rate Variability in Participants Under Stressful Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Stress
Keywords: psychological stress
animal-assisted intervention
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: In this study, the effects of an animal-assisted intervention on people with increased stress levels are investigated. The data collected will be compared with those of participants with high stress levels but without animal-assisted intervention (participants only observe nature) and with a control group consisting of people without stress exposure.

The study will be performed in the following setting: Questionnaire examination on chronic stress, questionnaire on current well-being and heart rate variability (HRV) measurement before the horse-assisted intervention, one HRV measurement and one questionnaire examination (POMS) on current well-being after the horse-assisted intervention, one questionnaire (POMS) on current well-being 5 days after the horse-assisted intervention.

Detailed description: The early recognition of chronic stressors, which are often neglected by those affected until physical symptoms appear, is of essential importance. In addition to psychopharmacological therapy modalities, complementary methods such as animal-assisted intervention should also be considered in order to expand the therapeutic spectrum and thus prevent stress-associated consequential harms as early as possible.

Stress has gained importance in recent years not only in the medical context, but also due to its economic relevance. Chronic stress in particular leads to numerous medically relevant secondary diseases and to increased sick leaves and even permanent incapacity to work. One possible intervention to reduce stress could be animal-assisted intervention.

Primary hypothesis: The use of animal-assisted intervention in people diagnosed with chronic stressful situations will lead to measurable increases in heart rate variability.

Secondary hypothesis: The use of animal-assisted intervention in people diagnosed with chronic stressful situations leads to improved well-being (target parameter: POMS questionnaire)

Eligibility criteria: Inclusion Criteria:

* Male, female and diverse
* Age between 18-75 years

Exclusion criteria:

* Animal hair allergies (especially horse hair allergies, fear of horses)
* Acute severe psychiatric conditions (e.g. psychosis)
* Persons, unable to give signed informed consent,
* All persons, who have not signed the informed consent form.

Primary outcomes:
measure: Change in heart rate variability
timeFrame: Time point 1: Baseline heart rate variability before the animal assisted intervention, Time point 2: heart rate variability immediately after the animal-assisted intervention
Secondary outcomes:
measure: Change in state of mood states (Profile of Mood States Questionnaire)
timeFrame: Time point 1: Baseline state of mood states before the animal assisted intervention, Time point 2: state of mood states immediately after the animal-assisted intervention
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz, Graz, Austria
name: Andreas Baranyi
role: PRINCIPAL_INVESTIGATOR
References: