Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
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)
Assessment method [1] 0 0
Positive and negative affect will be assessed using the PANAS at three time points. The primary outcome is the change in both subscale scores from post-stress to post-intervention across groups.
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)
Assessment method [2] 0 0
Participants' state anxiety will be measured at baseline, after the stress induction task, and after the intervention using the six-item short-form State-Trait Anxiety Inventory (STAI-State). The primary comparison will be change in scores from post-stress to post-intervention across the three groups.
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)
Assessment method [3] 0 0
Participants will rate their current level of stress on a 100 mm Visual Analog Scale at three time points. The change from post-stress induction to post-intervention will be compared across groups.
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
Assessment method [1] 0 0
Participants' heart rate will be measured at three time points (baseline, post-stress induction and post-intervention) using an automated digital monitor. HR will be measured in beats per minute (BPM).
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
Assessment method [2] 0 0
Participants' blood pressure will be measured at three time points (baseline, post-stress induction and post-intervention) using an automated digital monitor. BP will be recorded in millimeters of mercury (mmHg), capturing both systolic (SBP) and diastolic (DBP) values.
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)
Assessment method [3] 0 0
Participants in the Paro and Weighted Sensory Toy groups will complete visual analog scales (VAS) rating their enjoyment and engagement with the intervention. Each scale is 100 mm in length, anchored with "Not at all" (0 mm) to "Extremely" (100 mm). Higher scores indicate greater enjoyment or engagement.
Timepoint [3] 0 0
Immediately after intervention (within approximately 1 hour of study start)
Secondary outcome [4] 0 0
Qualitative feedback on participant experience
Assessment method [4] 0 0
Participants will provide open-ended qualitative feedback about their experience with their assigned intervention (Paro, Weighted Toy or Control). Responses will be analysed using thematic analysis to identify common themes.
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Nina Akulova
Address 0 0
Country 0 0
Phone 0 0
+64220903778
Email 0 0
naku935@aucklanduni.ac.nz
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