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

NCT ID: NCT07036354

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-06

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Graduate students often experience high levels of stress and anxiety due to academic demands, financial pressures, and time constraints. These stresses can stem from rigorous coursework, competitive environments, and the pressure to meet academic and personal expectations. Additionally, many students must manage part-time jobs, clinical rotations, or other academic obligations while maintaining personal relationships and responsibilities. The financial strain of student loans, tuition costs, and daily living often can add to the many plates graduate students handle. Time constraints, particularly the need to balance multiple responsibilities with limited hours in the day, frequently result in students prioritizing academics over self-care. As a result, the cumulative toll of these stressors can lead to the presentation of chronic stress and anxiety, which research has linked to increased pain sensitivity. This heightened pain sensitivity can negatively impact overall well-being and academic performance, making it more difficult for students to concentrate, remain motivated, and succeed in their programs.1

One intervention to combat these effects is human-animal interaction (HAI), which has been shown to reduce self-reported stress and anxiety scores, enhance mood, and promote relaxation.2 Additionally, HAI has also been shown to significantly reduce heart rate in participants.2 Previous research has explored the psychological benefits of HAI, but its effects on physiological measures such as pain pressure thresholds (PPT) remain unclear. PPTs are commonly used to estimate pain sensitivity, which is often heightened in individuals experiencing chronic stress and anxiety due to dysregulation of the body's stress response systems.1 Examining the relationship between anxiety and pain sensitivity through PPTs may provide insight into the potential physiological benefits of interventions such as human-animal interaction (HAI).

PPT refers to the minimum amount of pressure that induces pain in the participant and is commonly used to assess pain sensitivity.3 Pain sensitivity refers to an individual's perception of and ability to tolerate an enduring painful stimulus. Although pain is a subjective measure, it can be influenced by the individual's perception. Research has shown that if an individual's stress tolerance is low, then they are more likely to experience elevated intensity of pain.4,5 Furthermore, research shows that if an individual has experienced an adverse life experience that they are more likely to experience a heightened sensitivity and impaired regulation of stress and pain responses.6,7 This stress and anxiety can affect PPT measures, making individuals more sensitive to perceived pain, thus lowering an individual's PPT. Recent studies using cortical testing have found that pain sensitivity is also linked to activity and neurotransmitter levels in brain regions associated with pain processing.7 Elevated glutamate levels in these cortical areas, for instance, have been correlated with greater pain perception, further highlighting the connection between the brain's stress response and physical pain.7 On the other hand, relaxation techniques and positive social environments, including those with animals, may help increase PPT measurements in individuals who have stress-related anxiety.6,7 The purpose of this study is to evaluate the effects of HAI on both pain pressure thresholds and anxiety levels in graduate students. Specifically, this study aims to determine whether repeated HAI sessions influence pre- and post-intervention measures of PPT and anxiety.

Materials and Methods Participants The sample for this study will be a sample of convenience. The research project will be presented in person to graduate students at Wichita State University and followed up with an email to seek participants. Participants will be randomly placed into two groups - experimental (HAI) and control (GHE).

Informed Consent Informed consent will be read and signed by all participants prior to beginning the study. This study has been submitted to the Wichita State University Institutional Review Board for approval; status is pending as of this writing.

Animal A therapy-dog-in-training, "Ellie", will be provided by the handler for the duration of the research. Ellie is in the process of being certified through PawPartners. She has completed the proper health and behavior screenings to ensure her fitness for human-animal interaction.

Interaction Environments The HAI sessions will be held in a quiet, temperature-controlled room furnished with comfortable seating. Subjects in the experimental group will be given 60 minutes (15 minutes over 4 weeks) of unstructured interaction with Ellie. The experimental group was able to interact with Ellie in any way that they choose, including playing with a toy, playing fetch, or regular petting, if it is safe for both Ellie and the subject. The control group was given similar accommodation and focused on general health education to assist with the management of stress and anxiety. The control group was given handouts and the opportunity to engage in discussions regarding the benefits of walking, sleep hygiene, ways to recognize stress and anxiety, and different methods to deal with stress and anxiety.

Data Analysis A paired t-test will be used to analyze the data for statistically significant differences for both the HAI, within group, and GHE group, within groups. The variable analyzed by the paired t-test was self-reported anxiety scores done at the beginning and end of the study by both the experimental group and the control group. The independent variable was time, and the dependent variable was the anxiety levels measured with the GAD-7 Scale and AAS, as well as PPTs, BP, HR, and salivary cortisol.

A mixed design ANOVA was used to separately evaluate if there were statistically significant differences for both the experimental group, within group, and for the control group, within group. The measure analyzed by the repeated measures ANOVA was pain pressure threshold (PPT) testing performed once a week for 4 weeks. Data will be recorded during each testing session. The independent variable was time, split into 4 weeks, and the dependent variable was pressure values.

Two separate independent t-tests will be used to evaluate if there were statistically significant differences between the experimental and control groups in graduate students. The first measure analyzed by an independent t-test was self-reported anxiety scores for the experimental and control groups at the end of the study. The independent variable for this test was human animal interaction, and the dependent variable was self-reported anxiety scores. The second measure analyzed by an independent t-test was final pressure values at the end of the study for the experiment and the control group. The independent variable for this test was human animal interaction, and the dependent variable was pain pressure threshold values.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human-animal Interaction Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Human-Animal Interaction

Group Type EXPERIMENTAL

Human-Animal Interaction

Intervention Type OTHER

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

General Health Education

Group Type ACTIVE_COMPARATOR

General Health Education

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Human-Animal Interaction

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

Intervention Type OTHER

General Health Education

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wichita State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nicole D Windsor, PT, DPT, PhD, FAAOMPT

Associate Teaching Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wichita State University

Wichita, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27649042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25902791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28795169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36624753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29882342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36983246 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB6006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.