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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06975007




Registration number
NCT06975007
Ethics application status
Date submitted
28/04/2025
Date registered
16/05/2025

Titles & IDs
Public title
Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy
Scientific title
Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy: A Randomised Experimental Study
Secondary ID [1] 0 0
23002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Paro Robotic Companion Seal
Treatment: Devices - Weighted Sensory Toy

Experimental: Paro Robot Interaction - Participants will interact with Paro, a robotic companion seal, for 15 minutes following a stress induction task. Paro responds to touch and sound.

Experimental: Weighted Toy Interaction - Participants will hold and interact with a weighted sensory toy for 15 minutes following a stress induction task. The weighted toy provides deep pressure stimulation for calming effects.

No intervention: Control Group (No Intervention) - Participants will sit quietly for 15 minutes without any intervention following a stress induction task. This group allows natural recovery from stress without external aids.


Treatment: Devices: Paro Robotic Companion Seal
Paro is an interactive robotic companion designed to simulate the behaviour of a baby harp seal. It responds to touch, light, sound, posture and temperature, providing tactile and social interaction for stress relief.

Treatment: Devices: Weighted Sensory Toy
A soft, weighted animal-shaped toy (dog) designed to provide deep pressure stimulation. Participants hold or interact with the toy for 15 minutes following a stress induction task to promote relaxation and stress reduction.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in affect (Positive and Negative Affect Schedule - PANAS)
Timepoint [1] 0 0
Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Primary outcome [2] 0 0
Change in state anxiety scores (STAI-State short form)
Timepoint [2] 0 0
Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
Primary outcome [3] 0 0
Change in subjective stress levels (Visual Analog Scale for stress)
Timepoint [3] 0 0
Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
Secondary outcome [1] 0 0
Change in heart rate
Timepoint [1] 0 0
Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Secondary outcome [2] 0 0
Change in blood pressure
Timepoint [2] 0 0
Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Secondary outcome [3] 0 0
Participant ratings of enjoyment and engagement (VAS scales)
Timepoint [3] 0 0
Immediately after intervention (within approximately 1 hour of study start)
Secondary outcome [4] 0 0
Qualitative feedback on participant experience
Timepoint [4] 0 0
Immediately after intervention (within approximately 1 hour of study start)

Eligibility
Key inclusion criteria
* over 18 years old
* fluent in English
* free from diagnosed anxiety or stress-related disorders
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* cardiovascular conditions that may affect heart rate and blood pressure measurements
* existing anxiety disorders or panic disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Broadbent, Professor
Address 0 0
Department of Psychological Medicine, The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nina Akulova
Address 0 0
Country 0 0
Phone 0 0
+64220903778
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06975007