- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630600
Presence of Aquarium in the Waiting Room of a Geriatric Dental Clinic
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
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8032
- Recruiting
- Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich
-
Contact:
- Andrea Lundberg, med. dent.
- Phone Number: +41446343341
- Email: andrea.lundberg@zzm.uzh.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults ≥18 years
- Able to give informed consent as documented by signature.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Normal waiting room
|
Normal waiting room without an aquarium
|
|
Experimental: Intervention#1
Waiting room with partially-equipped aquarium (without fish)
|
Waiting room with a partially-equipped Aquarium
|
|
Experimental: Intervention#2
Waiting room with fully-equipped aquarium (with fish)
|
Waiting room with a fully-equipped Aquarium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure (systolic and diastolic)
Time Frame: Day 0
|
Stress levels
|
Day 0
|
|
Heart rate
Time Frame: Day 0
|
Stress levels
|
Day 0
|
|
STAI-6
Time Frame: Day 0
|
6-item Short State Trait Anxiety Inventory
|
Day 0
|
|
Feeling scale
Time Frame: Day 0
|
Mood
|
Day 0
|
|
Felt Arousal Scale
Time Frame: Day 0
|
Mood
|
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Murali Srinivasan, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UZH_ABS_2020_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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