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Not yet recruitingNCT05703165Updated Sep 29, 2025

Horse-assisted Intervention, Heart Rate Variability & Stress

An interventional study of animal-assisted intervention and watching the countryside in Psychological Stress, sponsored by Medical University of Graz. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Psychological Stress

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Keywords

  • psychological stress
  • animal-assisted intervention
03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's planned enrollment of 123 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
123 participants (estimated)

Study arms

  • 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.

    Behavioral: animal-assisted intervention

  • Active comparator
    subjects with stress burden and without animal-assisted intervention

    Study participants only observe the natural environment.

    Behavioral: 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.

    Behavioral: animal-assisted intervention

Interventions

  • Behavioralanimal-assisted intervention

    horse-assisted intervention

  • Behavioralwatching the countryside

    just watching the countryside

06

What researchers measure

Primary outcomes

  1. 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 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 outcomes

  1. 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 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

07

Study locations

1 site
  • Medical University of Graz
    Graz, Styria 8036, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05703165
Lead sponsor
Medical University of Graz
Responsible party
Andreas Baranyi (Assoc.Prof. Dr., Medical University of Graz) — Principal investigator
First posted
Jan 27, 2023
Start date
May 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Sep 29, 2025

Study contacts

Andreas Baranyi, M.D.
Contact
an.baranyi@medunigraz.at
004331638586241
Bettina Frühwirth
Contact
bettina.fruehwirth@stud.medunigraz.at
Andreas Baranyi
principal investigator · Medical University of Graz, Graz, Austria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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