- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05703165
Horse-assisted Intervention, Heart Rate Variability & Stress
Horse-assisted Intervention and Heart Rate Variability in Participants Under Stressful Conditions
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andreas Baranyi, M.D.
- Phone Number: 004331638586241
- Email: an.baranyi@medunigraz.at
Study Contact Backup
- Name: Bettina Frühwirth
- Email: bettina.fruehwirth@stud.medunigraz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8036
- Medical University of Graz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: subjects with stress burden and animal-assisted intervention
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.
|
horse-assisted intervention
|
|
Active Comparator: subjects with stress burden and without animal-assisted intervention
Study participants only observe the natural environment.
|
just watching the countryside
|
|
Active Comparator: subjects without stress burden and with animal-assisted intervention
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.
|
horse-assisted intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in heart rate variability
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
|
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)
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreas Baranyi, Medical University of Graz, Graz, Austria
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34-521
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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