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临床试验/NCT06975007
NCT06975007尚未招募不适用

Comparing the Stress-Reducing Effects of a Robotic Pet and a Weighted Toy: A Randomised Experimental Study

University of Auckland, New Zealand1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
Change in affect (Positive and Negative Affect Schedule - PANAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Paro Robotic Companion Seal (Device)

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.

干预措施: Weighted Sensory Toy (Device)

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.

结局指标

主要结局

Change in affect (Positive and Negative Affect Schedule - PANAS)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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))

研究者

发起方
University of Auckland, New Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Akulova

student

University of Auckland, New Zealand

研究点 (1)

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