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临床试验/NCT06248710
NCT06248710招募中2 期

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

Dr. Karin Hediger1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年1月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
176
试验地点
1
主要终点
Trust in the therapist

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Signed informed consent

排除标准

  • 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

研究组 & 干预措施

Condition 1: Oxytocin + dog present

Experimental

干预措施: Animal-Assisted Intervention (Other)

Condition 1: Oxytocin + dog present

Experimental

干预措施: Oxytocin nasal spray (Drug)

Condition 2: Oxytocin + no dog present

Experimental

干预措施: Oxytocin nasal spray (Drug)

Condition 3: Placebo + dog present

Experimental

干预措施: Animal-Assisted Intervention (Other)

Condition 3: Placebo + dog present

Experimental

干预措施: Placebo (Drug)

Condition 4: Placebo + no dog present

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Trust in the therapist

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Dr. Karin Hediger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Karin Hediger

Prof. Dr. Karin Hediger

University of Basel

研究点 (1)

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