Dog Presence and Oxytocin on Trust Towards Therapists

NCT ID: NCT06248710

Last Updated: 2024-11-05

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Symptoms Human-Animal Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Condition 1: Oxytocin + dog present

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

Syntocinon nose spray is usually applied in the context of labour and breast feeding. In this study, however, it will be used to induce an oxytocin (OT) release. Participants will apply three sprays in each nostril which will result in a dose of 24 I.U of oxytocin per participant

Animal-Assisted Intervention

Intervention Type OTHER

The dogs involved in the study are trained and used to work with different people in animal-assisted interventions. The dog will be familiarized with the room and the material as well as the staff of the study. The dog will be specifically trained for this study. The dog will be involved for a maximum of 3 sessions per day (approx. 20 minutes in total) and 2 days per week.

Condition 2: Oxytocin + no dog present

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

Syntocinon nose spray is usually applied in the context of labour and breast feeding. In this study, however, it will be used to induce an oxytocin (OT) release. Participants will apply three sprays in each nostril which will result in a dose of 24 I.U of oxytocin per participant

Condition 3: Placebo + dog present

Group Type EXPERIMENTAL

Animal-Assisted Intervention

Intervention Type OTHER

The dogs involved in the study are trained and used to work with different people in animal-assisted interventions. The dog will be familiarized with the room and the material as well as the staff of the study. The dog will be specifically trained for this study. The dog will be involved for a maximum of 3 sessions per day (approx. 20 minutes in total) and 2 days per week.

Placebo

Intervention Type DRUG

The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.

Condition 4: Placebo + no dog present

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.

Interventions

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Oxytocin nasal spray

Syntocinon nose spray is usually applied in the context of labour and breast feeding. In this study, however, it will be used to induce an oxytocin (OT) release. Participants will apply three sprays in each nostril which will result in a dose of 24 I.U of oxytocin per participant

Intervention Type DRUG

Animal-Assisted Intervention

The dogs involved in the study are trained and used to work with different people in animal-assisted interventions. The dog will be familiarized with the room and the material as well as the staff of the study. The dog will be specifically trained for this study. The dog will be involved for a maximum of 3 sessions per day (approx. 20 minutes in total) and 2 days per week.

Intervention Type OTHER

Placebo

The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Karin Hediger

OTHER

Sponsor Role lead

Responsible Party

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Dr. Karin Hediger

Prof. Dr. Karin Hediger

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Basel

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Karin Hediger, Prof. Dr.

Role: CONTACT

+41 (0)61 207 65 80

Elena Pauli, MSc

Role: CONTACT

+41 (0)61 207 69 58

Facility Contacts

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Karin Hediger

Role: primary

+41795197885

Fabio Carbone

Role: backup

References

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Algoe SB, Kurtz LE, Grewen K. Oxytocin and Social Bonds: The Role of Oxytocin in Perceptions of Romantic Partners' Bonding Behavior. Psychol Sci. 2017 Dec;28(12):1763-1772. doi: 10.1177/0956797617716922. Epub 2017 Oct 2.

Reference Type BACKGROUND
PMID: 28968183 (View on PubMed)

Bakermans-Kranenburg MJ, van I Jzendoorn MH. Sniffing around oxytocin: review and meta-analyses of trials in healthy and clinical groups with implications for pharmacotherapy. Transl Psychiatry. 2013 May 21;3(5):e258. doi: 10.1038/tp.2013.34.

Reference Type BACKGROUND
PMID: 23695233 (View on PubMed)

Feldman R, Weller A, Zagoory-Sharon O, Levine A. Evidence for a neuroendocrinological foundation of human affiliation: plasma oxytocin levels across pregnancy and the postpartum period predict mother-infant bonding. Psychol Sci. 2007 Nov;18(11):965-70. doi: 10.1111/j.1467-9280.2007.02010.x.

Reference Type BACKGROUND
PMID: 17958710 (View on PubMed)

Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.

Reference Type BACKGROUND
PMID: 15931222 (View on PubMed)

Nagasawa M, Mitsui S, En S, Ohtani N, Ohta M, Sakuma Y, Onaka T, Mogi K, Kikusui T. Social evolution. Oxytocin-gaze positive loop and the coevolution of human-dog bonds. Science. 2015 Apr 17;348(6232):333-6. doi: 10.1126/science.1261022. Epub 2015 Apr 16.

Reference Type BACKGROUND
PMID: 25883356 (View on PubMed)

Powell, L., Guastella, A. J., McGreevy, P. D., Bauman, A., Edwards, K. M., & Stamatakis, E. (2018). The physiological function of oxytocin in humans and its acute response to human-dog interactions: A review of the literature. Journal of Veterinary Behavior, 30, 25-32. https://doi.org/10.1016/j.jveb.2018.10.008

Reference Type BACKGROUND

Crits-Christoph P, Rieger A, Gaines A, Gibbons MBC. Trust and respect in the patient-clinician relationship: preliminary development of a new scale. BMC Psychol. 2019 Dec 30;7(1):91. doi: 10.1186/s40359-019-0347-3.

Reference Type BACKGROUND
PMID: 31888759 (View on PubMed)

Coleman, J. A., Green, B., Garthe, R. C., Worthington Jr, E. L., Barker, S. B., & Ingram, K. M. (2016). The Coleman Dog Attitude Scale (C-DAS): development, refinement, validation, and reliability. Applied Animal Behaviour Science, 176, 77-86.

Reference Type BACKGROUND

Gloster, A. T., Block, V. J., Klotsche, J., Villanueva, J. E., Rinner, M. T. B., Benoy, C., Walter, M., Karekla, M., & Bader, K. (2021). Psy-Flex: A contextually sensitive measure of psychological flexibility. Journal of Contextual Behavioral Science, 22, 13-23. https://doi.org/10.1016/j.jcbs.2021.09.001

Reference Type BACKGROUND

Other Identifiers

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2023-00523

Identifier Type: -

Identifier Source: org_study_id

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