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临床试验/NCT04696419
NCT04696419已完成不适用

Measuring the Effects of Different Intensities of Contact to Dogs

University of Aarhus2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Physiological measure, heart rate variablility

研究概览

简要总结

The study aims to identify and quantify objective non-invasive measures of the immediate effect of contact with dogs in a standardized experimental setup. Employing a within-subject design, the study includes healthy participants that are exposed to three different levels of contact to a dog compared with a no-dog control condition while obtaining measures of both physiological, behavioral, and psychological effects.

详细描述

Using a within-subjects design, we will compare four standardised and controlled test situations with different levels of dog contact:

  1. visual (V), 2) tactile and visual (TV), 3) tactile, visual, interaction (TVI), and 4)control (C).

The participants will be subjected to all four test situations on the same day, and will be randomly allocated to test order.

On the test day, we collect background information and baseline measures for the participants (baseline period, duration: 50 minutes), whereafter they rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the four test situations (10 minutes each) that are followed by rest intervals (30 minutes each).

The participants' interaction with the dog during the 10-minute test situations are standardised according to the specific contact treatment. Most physiological and all behavioural measures are recorded continuously throughout each test in order for us to link the "dosage" of dog (the different levels of contact) with the psychological responses and some physiological measures obtained before an after each test situation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • Normal cognitive functioning and physical movement
  • Ability to speak and read Danish

排除标准

  • Known medical, psychiatric or neurological disease
  • Use of psychotropic medications
  • Frequent use of pain medication
  • Use of illegal psychotropic drugs
  • Known allergies to dogs

结局指标

主要结局

Physiological measure, heart rate variablility

时间窗: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)

Heart rate variability is calculated from heart rate data

Salivary oxytocin

时间窗: After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes

Saliva is obtained from the testperson with a cotton swab which is chewed for one minute

Visual analogue scales measuring expected psychological and physiological effects of the test day including, including all four test situations

时间窗: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)

Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

The State-Trait Anxiety Inventory (STAI)

时间窗: Test periods: Measured immediately following the fourth test situation: t= 160 minutes

State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)

Physiological measure, heart rate

时间窗: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)

The test person wears self-adhesive electrodes and the heart rate is measured non-invasively,

Visual analogue scales measuring perceived psychological and physiological effects of of the test day including, including all four test situations

时间窗: After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes

Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

The Positive and Negative Affect Schedule (PANAS)

时间窗: Test periods: Measured immediately following the fourth test situation: t=160 minutes

Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from "very little /not at all" to "extremely much". The emotions differ in valens.

Physiological measure, galvanic skin response

时间窗: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)

The test person is fitted with electrodes on two fingers and galvanic skin response is measured non-invasively,

Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations

时间窗: Test periods: Measured immediately following the fourth test situation: t= 160 minutes

Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations

时间窗: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes

Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

Physiological measure, blood pressure

时间窗: After the last resting period: Measured at the end of the last resting period, following the last of the four test situations: t= 190 minutes

Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

Salivary cortisol

时间窗: After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes

Saliva is obtained from the testperson with a cotton swab which is chewed for one minute

次要结局

  • Quantitative behavioural measures - frequencies of behavioural elements(Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods))
  • Quantitative behavioural measures - duration of behavioural elements(Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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