Clinical trial NCT05516264: Behavioural and Physiological Responses to Dog Visits in Nursing Homes
Official title: Behavioural and Physiological Responses to Dog Visits in Nursing Homes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physiological Responses
Behavior
Mood
Keywords: Human-animal contact
Non-invasive measure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants from 2 nursing homes (25+25) are all receive three visit with a dog and three without a dog. It is randomised whter participents receive the dog visits first or last.
Primary purpose: BASIC_SCIENCE

Brief summary: In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural measurements to quantity the activity and the actual amount and intensity of contact to the dog.

Detailed description: The residents will receive six 10-minute visits, three visits with a dog and three without a dog, with a week-long break in between the two visit types. The participants will be randomly assigned to receive either the three dog visits or the three visits without a dog first. The visits will be from the same person, and the dog visits will be accompanied with the same dog each time. During dog visits, the dog will be available for touch, and the resident will be encouraged to interact with the dog.

Before each visit the resident is fitted with the equipment for measuring continuously recorded physiological measures and then relaxes for 30 minutes. Immediately before and five and 30 minutes after each visit, the investigators obtain a saliva sample to detect cortisol levels.

The behaviour of the participants will be video recorded during the visits to quantify the frequency and duration of predefined behavioural elements, using ethological methodology. The investigators will quantify the participants' activity during the visits as well as the frequency and duration of tactile contact with the dog, and verbal communication with the dog and the visitor.

In addition, the visitor and the observer present during the visit will subjectively assess the resident's perception of the visit.

Eligibility criteria: Inclusion Criteria:

* Age of 65 years or more
* Able to sit during visits (either in a chair or in a bed)

Exclusion Criteria:

* Known allergy to dogs
* Known fear of dogs

Primary outcomes:
measure: Heart rate
timeFrame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
measure: Heart rate
timeFrame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
measure: Heart rate
timeFrame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
measure: Heart rate
timeFrame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
measure: Heart rate
timeFrame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
measure: Heart rate
timeFrame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
measure: Heart rate variability
timeFrame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
measure: Heart rate variability
timeFrame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
measure: Heart rate variability
timeFrame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
measure: Heart rate variability
timeFrame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
measure: Heart rate variability
timeFrame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
measure: Heart rate variability
timeFrame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
measure: Behaviour during visits
timeFrame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
measure: Behaviour during visits
timeFrame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
measure: Behaviour during visits
timeFrame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
measure: Behaviour during visits
timeFrame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
measure: Behaviour during visits
timeFrame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
measure: Behaviour during visits
timeFrame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
measure: Salivary cortisol
timeFrame: Visit 1, 2 minutes before visit
measure: Salivary cortisol
timeFrame: Visit 2, 2 minutes before visit
measure: Salivary cortisol
timeFrame: Visit 3, 2 minutes before visit
measure: Salivary cortisol
timeFrame: Visit 4, 2 minutes before visit
measure: Salivary cortisol
timeFrame: Visit 5, 2 minutes before visit
measure: Salivary cortisol
timeFrame: Visit 6, 2 minutes before visit
measure: Salivary cortisol
timeFrame: Visit 1, 5 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 2, 5 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 3, 5 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 4, 5 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 5, 5 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 6, 5 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 1, 30 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 2, 30 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 3, 30 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 4, 30 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 5, 30 minutes after visit
measure: Salivary cortisol
timeFrame: Visit 6, 30 minutes after visit
Secondary outcomes:
measure: The visitor's and observer's perception of how the visit was experienced by the test person.
timeFrame: 5 minutes after visit 1
measure: The visitor's and observer's perception of how the visit was experienced by the test person.
timeFrame: 5 minutes after visit 2
measure: The visitor's and observer's perception of how the visit was experienced by the test person.
timeFrame: 5 minutes after visit 3
measure: The visitor's and observer's perception of how the visit was experienced by the test person.
timeFrame: 5 minutes after visit 4
measure: The visitor's and observer's perception of how the visit was experienced by the test person.
timeFrame: 5 minutes after visit 5
measure: The visitor's and observer's perception of how the visit was experienced by the test person.
timeFrame: 5 minutes after visit 6
measure: Visual analoque scale of the testpersons' evaluation of the visit
timeFrame: 5 minutes after visit 1
measure: Visual analoque scale of the testpersons' evaluation of the visit
timeFrame: 5 minutes after visit 2
measure: Visual analoque scale of the testpersons' evaluation of the visit
timeFrame: 5 minutes after visit 3
measure: Visual analoque scale of the testpersons' evaluation of the visit
timeFrame: 5 minutes after visit 4
measure: Visual analoque scale of the testpersons' evaluation of the visit
timeFrame: 5 minutes after visit 5
measure: Visual analoque scale of the testpersons' evaluation of the visit
timeFrame: 5 minutes after visit 6
Other outcomes:
Locations:
city: Højslev
country: Denmark
facility: Karen Thodberg
Study officials:
References: