Horse-assisted Intervention, Heart Rate Variability & Stress

Study Overview
=================
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)

Official Title
-----------------
Horse-assisted Intervention and Heart Rate Variability in Participants Under Stressful Conditions

Conditions
-----------------
Psychological Stress

Intervention / Treatment
-----------------
* Behavioral: animal-assisted intervention
* Behavioral: watching the countryside


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subjects with stress burden and animal-assisted intervention<br>The 20-minute horse-assisted intervention takes place in compliance with basic safety precautions (safety bar between horse and participant) and after safety instruction in handling the therapy horse. The horse can be touched or stroked more or less intensively, depending on the needs and current state of mind of the study participant. | Behavioral: animal-assisted intervention<br>* horse-assisted intervention<br>|
| Active Comparator: subjects with stress burden and without animal-assisted intervention<br>Study participants only observe the natural environment. | Behavioral: watching the countryside<br>* just watching the countryside<br>|
| Active Comparator: subjects without stress burden and with animal-assisted intervention<br>The 20-minute horse-assisted intervention takes place in compliance with basic safety precautions (safety bar between horse and participant) and after safety instruction in handling the therapy horse. The horse can be touched or stroked more or less intensively, depending on the needs and current state of mind of the study participant. | Behavioral: animal-assisted intervention<br>* horse-assisted intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate variability | Change in heart rate variability immediately after animal-assisted intervention when compared with baseline heart rate variability before the animal assisted intervention. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in state of mood states (Profile of Mood States Questionnaire) | Change in state of mood states immediately after animal-assisted intervention when compared with baseline state of mood states before the animal assisted intervention (Profile of Mood States Questionnaire: minimum value= -24, maximum value = 177, lower scores indicative of people with more stable mood profiles). | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychological stress, animal-assisted intervention