Behavioural and Physiological Responses to Dog Visits in Nursing Homes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mood; Behavior; Physiological Responses
• Intervention / Treatment: Behavioral: Dog visits/control visits; Behavioral: Control visits/dog visits

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Højslev, Denmark, 7840
    • Karen Thodberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dog visits first; Participants receive the three dogs visits first and then, after a break, receive the three control visits	Behavioral: Dog visits/control visits; See arm description above
Other: Control visits first; Participants receive the three control visits first and then, after a break, receive the three dog visits	Behavioral: Control visits/dog visits; See arm description above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
Behaviour during visits	The test persons behaviour is observed	During visit no. 1, from 30 minutes before the visit to 30 minutes after
Behaviour during visits	The test persons behaviour is observed	During visit no. 2, from 30 minutes before the visit to 30 minutes after
Behaviour during visits	The test persons behaviour is observed	During visit no. 3, from 30 minutes before the visit to 30 minutes after
Behaviour during visits	The test persons behaviour is observed	During visit no. 4, from 30 minutes before the visit to 30 minutes after
Behaviour during visits	The test persons behaviour is observed	During visit no. 5, from 30 minutes before the visit to 30 minutes after
Behaviour during visits	The test persons behaviour is observed	During visit no. 6, from 30 minutes before the visit to 30 minutes after
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Human-animal contact; Non-invasive measure
• Other Study ID Numbers: ANIMAL CONTACT 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No