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Clinical Trials/NCT06248710
NCT06248710
Recruiting
Phase 2

Effects of Intranasal Oxytocin on Trust Towards Therapists and Dogs: A Randomized Controlled Trial in Healthy Adults

Dr. Karin Hediger1 site in 1 country176 target enrollmentJanuary 29, 2024

Overview

Phase
Phase 2
Intervention
Animal-Assisted Intervention
Conditions
Depressive Symptoms
Sponsor
Dr. Karin Hediger
Enrollment
176
Locations
1
Primary Endpoint
Trust in the therapist
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Oxytocin has been proposed as a neuroendocrine mechanism that may mediate the relationship between dog ownership and positive health outcomes and be linked to human-dog interactions and is thought to be a mechanism of interspecies bonding. While the role of oxytocin in human bonding behaviours and social behaviour, in general, is becoming well-established the role of oxytocin in human-animal interaction and Animal-Assisted Interventions (AAI) remains unclear. This research gap calls for more high-quality research investigating this possible neuroendocrine underlying mechanism to advance knowledge about AAI. If oxytocin indeed might be involved in interspecies bonding, intranasally administered oxytocin should not only enhance trust toward a human but also towards a dog.

Registry
clinicaltrials.gov
Start Date
January 29, 2024
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Karin Hediger
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Karin Hediger

Prof. Dr. Karin Hediger

University of Basel

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Signed informed consent

Exclusion Criteria

  • Pregnancy
  • Being scared of dogs or dog hair allergy by self-report
  • Any acute or chronic disease (e.g., chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes, respiratory disease, skin pathologies etc.)
  • Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
  • Drug consumption (THC, cocaine, heroin, etc.) within the past 24h before study appointment
  • Ongoing psychotherapy treatment
  • Sexual Intercourse within the past 24h before study appointment
  • Current disease involving respiratory system (e.g., influence, asthma etc.)
  • Insufficient German language skills to understand the instructions

Arms & Interventions

Condition 1: Oxytocin + dog present

Intervention: Animal-Assisted Intervention

Condition 1: Oxytocin + dog present

Intervention: Oxytocin nasal spray

Condition 2: Oxytocin + no dog present

Intervention: Oxytocin nasal spray

Condition 3: Placebo + dog present

Intervention: Animal-Assisted Intervention

Condition 3: Placebo + dog present

Intervention: Placebo

Condition 4: Placebo + no dog present

Intervention: Placebo

Outcomes

Primary Outcomes

Trust in the therapist

Time Frame: immediately after the intervention

The main outcome is trust in the therapist, measured by the Trust and Respect Scale. The current questionnaire contains 8 items, four for trust and four for respect. Each item is measured on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"), of which 4 are formulated negatively. High values indicate high trust toward the therapist for the positively framed items, and for the negatively framed items low values mean high trust toward the therapist.

Secondary Outcomes

  • therapeutic climate(immediately after the intervention)
  • Trust in the dog(immediately after the intervention)
  • therapeutic alliance(immediately after the intervention)
  • psychological flexibility(immediately after the intervention)
  • perceived emotional closeness to the dog(immediately after the intervention)
  • perceived stress(immediately after the intervention)
  • level of difficulty(immediately after the intervention)

Study Sites (1)

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