Clinical trial NCT06975007: Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy
Official title: Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy: A Randomised Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
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
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

1. Complete a stress induction task (Trier Social Stress Test);
2. Be randomly assigned to interact with Paro, hold a weighted toy, or sit quietly without intervention;
3. Have their heart rate and blood pressure measured;
4. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in affect (Positive and Negative Affect Schedule - PANAS)
timeFrame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
measure: Change in state anxiety scores (STAI-State short form)
timeFrame: Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
measure: Change in subjective stress levels (Visual Analog Scale for stress)
timeFrame: Baseline, immediately after stress induction, and immediately after intervention (~1 hour total)
Secondary outcomes:
measure: Change in heart rate
timeFrame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
measure: Change in blood pressure
timeFrame: Baseline, immediately after stress induction and immediately after intervention (approximately 1 hour total)
measure: Participant ratings of enjoyment and engagement (VAS scales)
timeFrame: Immediately after intervention (within approximately 1 hour of study start)
measure: Qualitative feedback on participant experience
timeFrame: Immediately after intervention (within approximately 1 hour of study start)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
affiliation: Department of Psychological Medicine, The University of Auckland
name: Elizabeth Broadbent, Professor
role: PRINCIPAL_INVESTIGATOR
References: