About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
over 18 years old
fluent in English
free from diagnosed anxiety or stress-related disorders
Disqualifiers
cardiovascular conditions that may affect heart rate and blood pressure measurements
existing anxiety disorders or panic disorders.
Trial design
Parallel
Treatments tested in this trial
Paro Robotic Companion Seal
DeviceParo 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 Toy
DeviceA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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).
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: