Experimental Study Testing the Self-regulation Effects of a Social Assistive Robot Prototype During Moments of Emotional Stress
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of change in scores on the State Anxiety subscale of the State-Trait Anxiety Inventory for Children (STAI-CH; Spielberger, 1973) between the groups
研究概览
简要总结
The present experimental study aims to explore the effect of an interactive smart toy on children's stress modulation during a stressful experience compared to a non-interactive prototype. It is expected that children given the interactive prototype will experience faster and more effective stress modulation, in comparison to those being given the non-interactive prototype.
These findings will complement the ecologically valid data from week-long at-home deployments of the interactive prototype with families with low socioeconomic status.
详细描述
The proposed experimental design relies on an established task that can induce a short-term stress response to enable us to the test of efficacy of the smart toy in helping children regulate their emotions in controlled settings. The investigators will use an adapted version of the well-established Trier Social Stress Test for Children (TSST-C). The TSST-C was chosen as it is one of the most popular and standardised methods to induce a strong psychosocial stress response in experimental settings, due to its socio-evaluative character and uncontrollability. Prior literature shows that (i) the TSST-C is suitable for children in our age range; and (ii) stress returns to normal levels shortly after children receive positive feedback from the experimenters.
The original TSST-C protocol consists of a preparation period, public speaking task and mental arithmetic task. The investigators have chosen to only use the preparation period, public speaking task and anticipation of the mental arithmetic task as stressors, as pilots suggest that these suffice to elicit a strong-enough stress response that will allow us to test the toy's efficacy; and it would be unethical to subject children to unnecessary tasks.
== Study protocol: ==
On arrival to the room where the experiment will take place, children in both groups will be informed that there are three tasks involved in the study:
- giving a speech,
- a calculation task, and
- helping a newly discovered creature (the toy) which appears to be anxious calm down.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will not be aware of the other condition, i.e., that the device could be interactive/non-interactive.
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 7-10 years
- •Understand English sufficiently to take part and complete study materials
排除标准
- •Aged <7 years or >10 years
- •Does not understand English sufficiently to take part and complete study materials
研究组 & 干预措施
Control group: Non-interactive toy prototype
30 children will be given the same toy as participants in the experimental group, but without the interactive features (haptic feedback).
干预措施: Non-interactive toy prototype (Device)
Experimental: Interactive toy prototype
30 children will be given the same toy as participants in the control group, but with the interactive features (haptic feedback).
干预措施: Interactive toy prototype (Device)
结局指标
主要结局
Comparison of change in scores on the State Anxiety subscale of the State-Trait Anxiety Inventory for Children (STAI-CH; Spielberger, 1973) between the groups
时间窗: 4 timepoints during a single study visit: (i) baseline ; (ii) right before participants are asked to perform the speech task; (iii) right after the speech task; and (iv) right after the 5-minute exposure to one of the two conditions
The STAI-CH is a widely used instrument for measuring anxiety in children. The state subscale consists of 20 items which measure anxiety as a fleeting emotional state. Each STAI-CH item is a 3-point rating scale for which values of 1, 2, or 3 are assigned for each of the three alternative choices. Thus, scores on the subscale can range from a minimum of 20 to a maximum score of 60. Higher scores indicate greater anxiety.
Comparison of change in physiological stress levels between the groups
时间窗: Continuously from baseline until the end of the experimental session (approximately 1 hour).
Physiological stress reactivity will be measured by an Empatica E4 wristband which will continuously and non-intrusively monitor participants' heart rate and electrodermal activity throughout the experimental session. The change in physiological stress levels between the preparation for the speech task and post-exposure to one of the two conditions will be compared between the two participant groups.
次要结局
未报告次要终点