Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04630600 |
Other study ID # |
UZH_ABS_2020_1 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
June 2021 |
Study information
Verified date |
January 2021 |
Source |
University of Zurich |
Contact |
Andrea Lundberg, med. dent. |
Phone |
+41446343341 |
Email |
andrea.lundberg[@]zzm.uzh.ch |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.