Horse-assisted Intervention, Heart Rate Variability & Stress

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05703165
• Other study ID #: 34-521
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: Andreas Baranyi, M.D.
• Phone: 004331638586241
• Email: an.baranyi[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 123
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• animal-assisted intervention
horse-assisted intervention
• watching the countryside
just watching the countryside

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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