Evaluation of the Effects of Human-Animal Interaction on Anxiety in Graduate Students

NCT07036354 | Active Not Recruiting

• 1 other identifier: IRB6006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study's purpose is to evaluate the effects of human-animal interaction on physiological and psychological markers in graduate students. Graduate students face significant anxiety due to demanding coursework, long hours of studying, intense academic challenges, and the pressure to excel. Chronic stress in this population can contribute to elevated anxiety levels and measurable physiological changes, such as increased heart rate and blood pressure. Human-animal interaction (HAI) and its effect on student stress, test anxiety, and physiological markers have been studied on college campuses, largely focusing on undergraduate students. However, research investigating the impact of HAI on graduate student stress, test anxiety, and physiological markers in high-stakes programs is limited. This study will evaluate the effectiveness of repeated HAI on graduate students' physiological markers and anxiety. The results of this study will assist participants, students outside this study, and the program administrators to appreciate the immense value of a full-time therapy dog on campus, facilitating the human-animal bond in higher education.

Conditions

Human-animal Interaction; Anxiety

Outcome Measures

Primary Outcomes (2)

• Pain pressure threshold measurement

  The pain pressure threshold (PPT) is the level of pressure at which a stimulus, initially perceived as non-painful, becomes painful. It's a measure of how sensitive a tissue is to pressure and is often used in clinical settings to assess pain perception and identify potential pain-related conditions. PPT testing helps healthcare providers assess pain sensitivity, muscle tenderness, and potential underlying conditions. It's typically measured using a pressure algometer, a device that applies controlled pressure to a specific area of the body. Pressure is gradually increased on the area being tested until the subject reports that the pressure sensation changes to pain. The pressure at which the pain sensation is reported is recorded as the PPT. PPT may be measured at different locations on the body, both near and far from the area where pain is experienced. The pressure at which pain is first reported is recorded, often in units like kilopascals (kPa) or kilograms-force (kgf).

  From beginning of study to end of 4 weekly sessions of interventions

• Salivatory Cortisol Levels

  Salivary cortisol testing assesses free cortisol levels in saliva, which reflect the biologically active portion of cortisol in the body. Normal ranges vary based on the time of day, with higher levels in the morning and lower levels at night. Cortisol levels naturally fluctuate throughout the day, with the highest levels typically in the early morning and the lowest in the evening. Salivary cortisol levels are often measured in nanograms per milliliter (ng/mL) or nanomoles per liter (nmol/L). Saliva collection is convenient and non-invasive, making it suitable for repeated measurements and for individuals who may have difficulty with blood draws.

  From beginning of study to end of 4 weekly sessions

Secondary Outcomes (3)

• Generalized Anxiety Disorder-7 (GAD-7)

  Beginning of the study to end of 4 weekly sessions of interventions

• Academic Anxiety Scale (AAS)

  Beginning of study to end of 4 weekly sessions of interventions

• Canine Behavioral Assessment & Research Questionnaire (C-BARQ)

  Beginning of the study to the end of the 4 weekly interventions

Study Arms (2)

Human-Animal Interaction

EXPERIMENTAL

Other: Human-Animal Interaction

General Health Education

ACTIVE COMPARATOR

Other: General Health Education

Interventions

Human-Animal Interaction OTHER

HAI - participants spend a specific amount of time with a therapy dog in a controlled environment.

Human-Animal Interaction

General Health Education OTHER

GHE - participants will be educated on strategies to assist in managing general and academic anxiety.

General Health Education

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Enrolled and active first-year graduate students at Wichita State University,
• Between the ages of 20-35 years.

You may not qualify if:

• Participants diagnosed with allergies to dogs,
• Participants with a fear of dogs,
• Participants diagnosed with mental health disorders,
• Participants with on-going mental health treatment, counseling or medications,
• Participants with a known history of cardiac pathology and/or cardiac medications.

Sponsors & Collaborators

• Wichita State University: lead

Study Sites (1)

Wichita State University

Wichita, Kansas, 67202, United States

Location

Related Publications (6)

• Zunhammer M, Schweizer LM, Witte V, Harris RE, Bingel U, Schmidt-Wilcke T. Combined glutamate and glutamine levels in pain-processing brain regions are associated with individual pain sensitivity. Pain. 2016 Oct;157(10):2248-2256. doi: 10.1097/j.pain.0000000000000634.

  PMID: 27649042 BACKGROUND

• Generaal E, Vogelzangs N, Macfarlane GJ, Geenen R, Smit JH, de Geus EJ, Penninx BW, Dekker J. Biological stress systems, adverse life events and the onset of chronic multisite musculoskeletal pain: a 6-year cohort study. Ann Rheum Dis. 2016 May;75(5):847-54. doi: 10.1136/annrheumdis-2014-206741. Epub 2015 Apr 22.

  PMID: 25902791 BACKGROUND

• Abdallah CG, Geha P. Chronic Pain and Chronic Stress: Two Sides of the Same Coin? Chronic Stress (Thousand Oaks). 2017 Feb;1:2470547017704763. doi: 10.1177/2470547017704763. Epub 2017 Jun 8.

  PMID: 28795169 BACKGROUND

• Reezigt RR, Slager GEC, Coppieters MW, Scholten-Peeters GGM. Novice assessors demonstrate good intra-rater agreement and reliability when determining pressure pain thresholds; a cross-sectional study. PeerJ. 2023 Jan 4;11:e14565. doi: 10.7717/peerj.14565. eCollection 2023.

  PMID: 36624753 BACKGROUND

• Ein N, Li L, Vickers K. The effect of pet therapy on the physiological and subjective stress response: A meta-analysis. Stress Health. 2018 Oct;34(4):477-489. doi: 10.1002/smi.2812. Epub 2018 Jun 8.

  PMID: 29882342 BACKGROUND

• Wyns A, Hendrix J, Lahousse A, De Bruyne E, Nijs J, Godderis L, Polli A. The Biology of Stress Intolerance in Patients with Chronic Pain-State of the Art and Future Directions. J Clin Med. 2023 Mar 14;12(6):2245. doi: 10.3390/jcm12062245.

  PMID: 36983246 BACKGROUND

MeSH Terms

Conditions

Human-Animal Interaction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Teaching Professor

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 25, 2025
• Study Start: October 6, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data available 02/01/2026 and available for five (5) years.
• Access Criteria: Data will be available via www.figshare.com, a data repository

Locations

US (1)