NCT06975007

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

April 28, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

Stress reductionRobotic petParoWeighted sensory toyDeep pressure stimulationAcute stressTrier Social Stress Test (TSST)Heart rateBlood pressureHuman-robot interactionSensory modulation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)

Secondary Outcomes (4)

  • Change in heart rate

    Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)

  • Change in blood pressure

    Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)

  • Participant ratings of enjoyment and engagement (VAS scales)

    Immediately after intervention (within approximately 1 hour of study start)

  • Qualitative feedback on participant experience

    Immediately after intervention (within approximately 1 hour of study start)

Study Arms (3)

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.

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.

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.

Interventions

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.

Paro Robot Interaction

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.

Weighted Toy Interaction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years old
  • fluent in English
  • free from diagnosed anxiety or stress-related disorders

You may not qualify if:

  • cardiovascular conditions that may affect heart rate and blood pressure measurements
  • existing anxiety disorders or panic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Auckland

Auckland, 1023, New Zealand

Location

Study Officials

  • Elizabeth Broadbent, Professor

    Department of Psychological Medicine, The University of Auckland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 16, 2025

Study Start

May 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

confidential. Ethical requirements are to keep individual data confidential.

Locations