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临床试验/NCT04630600
NCT04630600Unknown不适用

Effect of the Presence of an Aquarium in the Waiting Room on the Pre-treatment Stress and Anxiety Levels of Adult Patients and Reception Staff: a Controlled Clinical Trial

University of Zurich2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
360
试验地点
2
主要终点
Blood pressure (systolic and diastolic)

研究概览

简要总结

The participants in this study will be subjected to a specific clinic waiting area ambience (1- no aquarium, 2- presence of aquarium with no fish, and 3- aquarium with fish) for their period of waiting before their intended dental visit and their stress and anxiety levels will be measured. Heart rate, blood pressure will be measured and other upon their arrival into the dental clinic waiting area and then again after 20 minutes of waiting in the waiting area. Anxiety will be measured using a six-item State-Trait Anxiety Inventory (STAI-6) questionnaire and the mood of the participants were assessed for valence and arousal, using the feeling scale, and the felt arousal scale. The data from the three different waiting room settings will be compared and statistically analysed to investigate if an aquarium has an impact, and in that case how.

详细描述

Dental anxiety is a well-known, common dilemma affecting many adults, observed more frequently in children and women. It is an emotional apprehensive state which is multifactorial and the origin is most commonly attributed to the anticipation of the painful stimulus that may arise during treatment. It has been suggested that environmental factors contribute to dental stress. Although quite trivial, the environment of a waiting room as well as the time spent waiting are parameters that can cause pre- treatment stress. Therefore, the waiting room must be considered an important first port for dealing with the individual's pre-treatment dental anxiety. Evidence in literature suggest that waiting room ambience plays a significant role in reducing the patient anxiety, for example images, audio-visual effects like the lighting, music and/or videos, presence of natural light, suitable reading material, aquariums have shown positive results. Beneficial effects of the presence of animals on the reduction of stress have also been reported in literature, and especially fish have shown a positive effect on the psychological well-being and stress levels; higher relaxation, less anxiety and better mood was reported by participants after a period of observing live fish.

  • The primary null hypothesis is that there will be no effect of an aquarium present in the waiting area on the pre-treatment anxiety and stress levels of participants receiving dental care.
  • The secondary hypothesis is that there will be no effect of an aquarium present in the waiting area on the stress and anxiety levels of the reception staff.
  • The tertiary hypothesis for this study is that the treating dentist will not perceive any difference in the stress and anxiety levels of the participants after observing the aquarium in the waiting area.
  • Patients ≥18 years, who are able to sign a consent form are included. The participants are subjected to a specific clinic waiting area ambience (1- no aquarium, 2- presence of aquarium with no fish, and 3- aquarium with fish) for their period of waiting before their intended dental visit and their stress and anxiety levels are measured. Heart rate, blood pressure will be measured and other upon their arrival into the dental clinic waiting area. Three measurements will be taken and then after 20 minutes of waiting another three measurements of the same will be made in order to see if the presence of an aquarium gave a decrease. Anxiety will be measured using a six-item State-Trait Anxiety Inventory (STAI-6) questionnaire and the mood of the participants were assessed for valence and arousal, using the feeling scale, and the felt arousal scale. The data from the three different settings will be compared and statistically analysed to investigate if an aquarium has an impact, and in that case how.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Adults ≥18 years
  • Able to give informed consent as documented by signature.

排除标准

  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • Visually impaired.
  • Participants enrolled already in another clinical trial.

结局指标

主要结局

Blood pressure (systolic and diastolic)

时间窗: Day 0

Stress levels

Heart rate

时间窗: Day 0

Stress levels

STAI-6

时间窗: Day 0

6-item Short State Trait Anxiety Inventory

Feeling scale

时间窗: Day 0

Mood

Felt Arousal Scale

时间窗: Day 0

Mood

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murali Srinivasan

Professor

University of Zurich

研究点 (2)

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