StressNCT06975007
Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy
A study testing Paro Robotic Companion Seal and Weighted Sensory Toy in people with Stress, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
The goal of this trial is to learn whether interacting with a robotic pet (Paro) or holding a weighted sensory toy can reduce stress in healthy adults after an acute stressful experience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Paro Robotic Companion Seal and Weighted Sensory Toy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years old
- fluent in English
- free from diagnosed anxiety or stress-related disorders
Who cannot join
- cardiovascular conditions that may affect heart rate and blood pressure measurements
- existing anxiety disorders or panic disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy: A Randomised Experimental Study
The goal of this trial is to learn whether interacting with a robotic pet (Paro) or holding a weighted sensory toy can reduce stress in healthy adults after an acute stressful experience. The main questions it aims to answer are:
- Does interacting with Paro or holding a weighted toy lower self-reported stress and anxiety levels?
- Does interacting with Paro or holding a weighted toy lower physiological markers of stress, such as heart rate and blood pressure?
Read more
Researchers will compare interaction with Paro (robotic pet), interaction with a weighted sensory toy and a control group with no intervention to see which method is most effective in reducing stress.
Participants will:
- Complete a stress induction task (Trier Social Stress Test);
- Be randomly assigned to interact with Paro, hold a weighted toy, or sit quietly without intervention;
- Have their heart rate and blood pressure measured;
- Complete surveys about their stress, anxiety and mood before and after the intervention.
Read the detailed description
The study investigates the immediate effectiveness of interacting with an interactive robotic pet (Paro, a robotic seal) or a weighted sensory modulation toy for reducing acute stress and anxiety. It aims to determine the comparative efficacy of these interventions relative to a control condition involving quiet relaxation. Participants will be randomly assigned to one of three experimental conditions: interaction with Paro, interaction with a weighted sensory toy, or a control group with no intervention.
All participants will first complete baseline measurements, including self-reported anxiety and stress assessments using validated instruments (State-Trait Anxiety Inventory, Positive and Negative Affect Schedule, and Visual Analog Scale), as well as physiological indicators of stress (heart rate and blood pressure). Subsequently, participants will undergo the Trier Social Stress Test (TSST), a validated procedure involving a brief public speaking task and mental arithmetic performed under evaluative conditions designed to induce moderate stress. Following the stress induction, participants will repeat stress and anxiety assessments and physiological measurements. They will then engage in their assigned intervention for 15 minutes. Post-intervention measurements of stress and anxiety, physiological markers, and perceived enjoyment/ engagement will be collected. Participants will also provide qualitative feedback regarding their intervention experiences.
- Conditions
- Stress
- Being tested
- Paro Robotic Companion Seal, Weighted Sensory Toy
- Keywords
- Stress reduction, Robotic pet, Paro, Weighted sensory toy, Deep pressure stimulation, Acute stress, Trier Social Stress Test (TSST), Heart rate, Blood pressure, Human-robot interaction, Sensory modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paro Robotic Companion SealDevice
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.
Weighted Sensory ToyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Paro Robot Interaction | Experimental | Participants will interact with Paro, a robotic companion seal, for 15 minutes following a stress induction task. Paro responds to touch and sound. Receives: Device: Paro Robotic Companion Seal |
| Weighted Toy Interaction | Experimental | 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. Receives: Device: Weighted Sensory Toy |
| Control Group (No Intervention) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in affect (Positive and Negative Affect Schedule - PANAS)
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.
Measured: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Change in state anxiety scores (STAI-State short form)
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.
Measured: Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
Change in subjective stress levels (Visual Analog Scale for stress)
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.
Measured: Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
Secondary outcomes (4)
Change in heart rate
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).
Measured: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Change in blood pressure
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.
Measured: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Participant ratings of enjoyment and engagement (VAS scales)
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.
Measured: Immediately after intervention (within approximately 1 hour of study start)
Qualitative feedback on participant experience
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.
Measured: Immediately after intervention (within approximately 1 hour of study start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startMay 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: interaction with a robotic companion (Paro), interaction with a weighted sensory toy or a control group with no intervention. Each participant will experience only one intervention condition following the stress induction task.
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Akulova, University of Auckland, New Zealand
- Investigators
- Elizabeth Broadbent, Professor, Principal investigator, Department of Psychological Medicine, The University of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975007
- Sponsor's protocol ID
- 23002
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential. Ethical requirements are to keep individual data confidential.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy: A Randomised Experimental Study
- ClinicalTrials.gov ID
- NCT06975007
- Acronym / sponsor ID
- 23002
- Conditions
- Stress
- Keywords
- Stress reduction, Robotic pet, Paro, Weighted sensory toy, Deep pressure stimulation, Acute stress, Trier Social Stress Test (TSST), Heart rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to learn whether interacting with a robotic pet (Paro) or holding a weighted sensory toy can reduce stress in healthy adults after an acute stressful experience. The main questions it aims to answer are:
- Does interacting with Paro or holding a weighted toy lower self-reported stress and anxiety levels?
- Does interacting with Paro or holding a weighted toy lower physiological markers of stress, such as heart rate and blood pressure?
Researchers will compare interaction with Paro (robotic pet), interaction with a weighted sensory toy and a control group with no intervention to see which method is most effective in reducing stress.
Participants will:
- Complete a stress induction task (Trier Social Stress Test);
- Be randomly assigned to interact with Paro, hold a weighted toy, or sit quietly without intervention;
- Have their heart rate and blood pressure measured;
- Complete surveys about their stress, anxiety and mood before and after the intervention.
Detailed description
The study investigates the immediate effectiveness of interacting with an interactive robotic pet (Paro, a robotic seal) or a weighted sensory modulation toy for reducing acute stress and anxiety. It aims to determine the comparative efficacy of these interventions relative to a control condition involving quiet relaxation. Participants will be randomly assigned to one of three experimental conditions: interaction with Paro, interaction with a weighted sensory toy, or a control group with no intervention.
All participants will first complete baseline measurements, including self-reported anxiety and stress assessments using validated instruments (State-Trait Anxiety Inventory, Positive and Negative Affect Schedule, and Visual Analog Scale), as well as physiological indicators of stress (heart rate and blood pressure). Subsequently, participants will undergo the Trier Social Stress Test (TSST), a validated procedure involving a brief public speaking task and mental arithmetic performed under evaluative conditions designed to induce moderate stress. Following the stress induction, participants will repeat stress and anxiety assessments and physiological measurements. They will then engage in their assigned intervention for 15 minutes. Post-intervention measurements of stress and anxiety, physiological markers, and perceived enjoyment/ engagement will be collected. Participants will also provide qualitative feedback regarding their intervention experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: interaction with a robotic companion (Paro), interaction with a weighted sensory toy or a control group with no intervention. Each participant will experience only one intervention condition following the stress induction task.
| Arm | Type | Receives |
|---|---|---|
| Paro Robot Interaction | Experimental | Device: Paro Robotic Companion SealParticipants will interact with Paro, a robotic companion seal, for 15 minutes following a stress induction task. Paro responds to touch and sound. |
| Weighted Toy Interaction | Experimental | Device: Weighted Sensory ToyParticipants 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. |
| Control Group (No Intervention) | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years old
- fluent in English
- free from diagnosed anxiety or stress-related disorders
Key exclusion criteria (2 listed)
- cardiovascular conditions that may affect heart rate and blood pressure measurements
- existing anxiety disorders or panic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paro Robotic Companion SealParo 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. | Device | Paro Robot Interaction |
| Weighted Sensory ToyA 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. | Device | Weighted Toy Interaction |
Primary outcome
Change in affect (Positive and Negative Affect Schedule - PANAS)
Time frame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
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.
Change in state anxiety scores (STAI-State short form)
Time frame: Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
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.
Change in subjective stress levels (Visual Analog Scale for stress)
Time frame: Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
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.
4 secondary outcomes
Change in heart rate
Time frame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Change in blood pressure
Time frame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
Participant ratings of enjoyment and engagement (VAS scales)
Time frame: Immediately after intervention (within approximately 1 hour of study start)
Qualitative feedback on participant experience
Time frame: Immediately after intervention (within approximately 1 hour of study start)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No. confidential. Ethical requirements are to keep individual data confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Broadbent, Professor principal investigator
Department of Psychological Medicine, The University of Auckland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paro Robotic Companion Seal and Weighted Sensory Toy in people with Stress, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Akulova (+64220903778, naku935@aucklanduni.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in affect (Positive and Negative Affect Schedule - PANAS) (time frame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.