NCT05703165

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jan 2028

First Submitted

Initial submission to the registry

January 10, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
3.3 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

January 10, 2023

Last Update Submit

September 23, 2025

Conditions

Psychological Stress

Keywords

psychological stressanimal-assisted intervention

Outcome Measures

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 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)

    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

Study Arms (3)

subjects with stress burden and animal-assisted intervention

EXPERIMENTAL

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

subjects with stress burden and without animal-assisted intervention

ACTIVE COMPARATOR

Study participants only observe the natural environment.

Behavioral: watching the countryside

subjects without stress burden and with animal-assisted intervention

ACTIVE COMPARATOR

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

animal-assisted interventionBEHAVIORAL

horse-assisted intervention

subjects with stress burden and animal-assisted interventionsubjects without stress burden and with animal-assisted intervention
watching the countrysideBEHAVIORAL

just watching the countryside

subjects with stress burden and without animal-assisted intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Andreas Baranyi

    Medical University of Graz, Graz, Austria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Baranyi, M.D.

CONTACT

004331638586241an.baranyi@medunigraz.at

Bettina Frühwirth

CONTACT

bettina.fruehwirth@stud.medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof. Dr.

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 27, 2023

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)