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Dog Presence and Oxytocin on Trust Towards Therapists

Plain-language guide to NCT06248710: phase 2, phase 3 randomized trial of Oxytocin, 176 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06248710
Phase
phase 2, phase 3
Status
recruiting participants
Start
2024-01-29
Completion (planned or actual)
2024-12-31
Participants
176 (estimated)
Design
randomized, quadruple-blind, basic_science
Conditions studied
Depressive Symptoms; Human-Animal Interaction
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Oxytocin.

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.

It had four arms (groups): Condition 1: Oxytocin + dog present (experimental), Condition 2: Oxytocin + no dog present (experimental), Condition 3: Placebo + dog present (experimental) and Condition 4: Placebo + no dog present (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

176 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age ≥ 18 years. Signed informed consent.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-01-29 with completion listed for 2024-12-31.

It ran at 1 site in Switzerland.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Trust in the therapist (time frame: immediately after the intervention).

It also tracked 9 secondary outcomes, for example Trust in the dog, perceived emotional closeness to the dog, perceived stress, perceived stress, level of difficulty and therapeutic alliance.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 176 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.