Behavioural and Physiological Responses to Dog Visits in Nursing Homes

Behavior Clinical Trial

Official title:

Behavioural and Physiological Responses to Dog Visits in Nursing Homes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516264
• Other study ID #: ANIMAL CONTACT 4
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: University of Aarhus
• Contact: Karen Thodberg, PhD
• Phone: +45 93522604
• Email: karen.thodberg[@]anis.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Mood
• Physiological Responses

Intervention

Behavioral:
• Dog visits/control visits
See arm description above
• Control visits/dog visits
See arm description above

Locations

Country	Name	City	State
Denmark	Karen Thodberg	Højslev

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	The test person wears a device placed on the upper arm	During visit no. 1, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate	The test person wears a device placed on the upper arm	During visit no. 2, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate	The test person wears a device placed on the upper arm	During visit no. 3, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate	The test person wears a device placed on the upper arm	During visit no. 4, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate	The test person wears a device placed on the upper arm	During visit no. 5, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate	The test person wears a device placed on the upper arm	During visit no. 6, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate variability	Heart rate variability is calculated from heart rate data	During visit no. 1, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate variability	Heart rate variability is calculated from heart rate data	During visit no. 2, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate variability	Heart rate variability is calculated from heart rate data	During visit no. 3, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate variability	Heart rate variability is calculated from heart rate data	During visit no. 4, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate variability	Heart rate variability is calculated from heart rate data	During visit no. 5, from 30 minutes before the visit to 30 minutes after
Primary	Heart rate variability	Heart rate variability is calculated from heart rate data	During visit no. 6, from 30 minutes before the visit to 30 minutes after
Primary	Behaviour during visits	The test persons behaviour is observed	During visit no. 1, from 30 minutes before the visit to 30 minutes after
Primary	Behaviour during visits	The test persons behaviour is observed	During visit no. 2, from 30 minutes before the visit to 30 minutes after
Primary	Behaviour during visits	The test persons behaviour is observed	During visit no. 3, from 30 minutes before the visit to 30 minutes after
Primary	Behaviour during visits	The test persons behaviour is observed	During visit no. 4, from 30 minutes before the visit to 30 minutes after
Primary	Behaviour during visits	The test persons behaviour is observed	During visit no. 5, from 30 minutes before the visit to 30 minutes after
Primary	Behaviour during visits	The test persons behaviour is observed	During visit no. 6, from 30 minutes before the visit to 30 minutes after
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 1, 2 minutes before visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 2, 2 minutes before visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 3, 2 minutes before visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 4, 2 minutes before visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 5, 2 minutes before visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 6, 2 minutes before visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 1, 5 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 2, 5 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 3, 5 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 4, 5 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 5, 5 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 6, 5 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 1, 30 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 2, 30 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 3, 30 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 4, 30 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 5, 30 minutes after visit
Primary	Salivary cortisol	Saliva is obtained from the testperson with a swab which held his/her mouth for one minute	Visit 6, 30 minutes after visit
Secondary	The visitor's and observer's perception of how the visit was experienced by the test person.	Minimum value 0 (worst possible visit) to 100 (best possible visit)	5 minutes after visit 1
Secondary	The visitor's and observer's perception of how the visit was experienced by the test person.	Minimum value 0 (worst possible visit) to 100 (best possible visit)	5 minutes after visit 2
Secondary	The visitor's and observer's perception of how the visit was experienced by the test person.	Minimum value 0 (worst possible visit) to 100 (best possible visit)	5 minutes after visit 3
Secondary	The visitor's and observer's perception of how the visit was experienced by the test person.	Minimum value 0 (worst possible visit) to 100 (best possible visit)	5 minutes after visit 4
Secondary	The visitor's and observer's perception of how the visit was experienced by the test person.	Minimum value 0 (worst possible visit) to 100 (best possible visit)	5 minutes after visit 5
Secondary	The visitor's and observer's perception of how the visit was experienced by the test person.	Minimum value 0 (worst possible visit) to 100 (best possible visit)	5 minutes after visit 6
Secondary	Visual analoque scale of the testpersons' evaluation of the visit	Minimum value 0 (worst possible experience) to 100 (best possible experience)	5 minutes after visit 1
Secondary	Visual analoque scale of the testpersons' evaluation of the visit	Minimum value 0 (worst possible experience) to 100 (best possible experience)	5 minutes after visit 2
Secondary	Visual analoque scale of the testpersons' evaluation of the visit	Minimum value 0 (worst possible experience) to 100 (best possible experience)	5 minutes after visit 3
Secondary	Visual analoque scale of the testpersons' evaluation of the visit	Minimum value 0 (worst possible experience) to 100 (best possible experience)	5 minutes after visit 4
Secondary	Visual analoque scale of the testpersons' evaluation of the visit	Minimum value 0 (worst possible experience) to 100 (best possible experience)	5 minutes after visit 5
Secondary	Visual analoque scale of the testpersons' evaluation of the visit	Minimum value 0 (worst possible experience) to 100 (best possible experience)	5 minutes after visit 6