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Horse-assisted Intervention, Heart Rate Variability & Stress

Primary Purpose

Psychological Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
animal-assisted intervention
watching the countryside
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Stress focused on measuring psychological stress, animal-assisted intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

subjects with stress burden and animal-assisted intervention

subjects with stress burden and without animal-assisted intervention

subjects without stress burden and with animal-assisted intervention

Arm Description

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.

Study participants only observe the natural environment.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 10, 2023
Last Updated
January 19, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05703165
Brief Title
Horse-assisted Intervention, Heart Rate Variability & Stress
Official Title
Horse-assisted Intervention and Heart Rate Variability in Participants Under Stressful Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
psychological stress, animal-assisted intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subjects with stress burden and animal-assisted intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
subjects with stress burden and without animal-assisted intervention
Arm Type
Active Comparator
Arm Description
Study participants only observe the natural environment.
Arm Title
subjects without stress burden and with animal-assisted intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
animal-assisted intervention
Intervention Description
horse-assisted intervention
Intervention Type
Behavioral
Intervention Name(s)
watching the countryside
Intervention Description
just watching the countryside
Primary Outcome Measure Information:
Title
Change in heart rate variability
Description
Change in heart rate variability immediately after animal-assisted intervention when compared with baseline heart rate variability before the animal assisted intervention.
Time Frame
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 Measure Information:
Title
Change in state of mood states (Profile of Mood States Questionnaire)
Description
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 Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Baranyi, M.D.
Phone
004331638586241
Email
an.baranyi@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Bettina Frühwirth
Email
bettina.fruehwirth@stud.medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Baranyi
Organizational Affiliation
Medical University of Graz, Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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Horse-assisted Intervention, Heart Rate Variability & Stress

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