Presence of Aquarium in the Waiting Room of a Geriatric Dental Clinic
Primary Purpose
Stress, Anxiety, Mood
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
No intervention
Partially-equipped aquarium in the waiting area
Fully-equipped aquarium in the waiting area
Sponsored by
About this trial
This is an interventional other trial for Stress
Eligibility Criteria
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.
Sites / Locations
- Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of ZurichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Control
Intervention#1
Intervention#2
Arm Description
Normal waiting room
Waiting room with partially-equipped aquarium (without fish)
Waiting room with fully-equipped aquarium (with fish)
Outcomes
Primary Outcome Measures
Blood pressure (systolic and diastolic)
Stress levels
Heart rate
Stress levels
STAI-6
6-item Short State Trait Anxiety Inventory
Feeling scale
Mood
Felt Arousal Scale
Mood
Secondary Outcome Measures
Full Information
NCT ID
NCT04630600
First Posted
November 3, 2020
Last Updated
January 13, 2021
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04630600
Brief Title
Presence of Aquarium in the Waiting Room of a Geriatric Dental Clinic
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Mood
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Normal waiting room
Arm Title
Intervention#1
Arm Type
Experimental
Arm Description
Waiting room with partially-equipped aquarium (without fish)
Arm Title
Intervention#2
Arm Type
Experimental
Arm Description
Waiting room with fully-equipped aquarium (with fish)
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Normal waiting room without an aquarium
Intervention Type
Other
Intervention Name(s)
Partially-equipped aquarium in the waiting area
Intervention Description
Waiting room with a partially-equipped Aquarium
Intervention Type
Other
Intervention Name(s)
Fully-equipped aquarium in the waiting area
Intervention Description
Waiting room with a fully-equipped Aquarium
Primary Outcome Measure Information:
Title
Blood pressure (systolic and diastolic)
Description
Stress levels
Time Frame
Day 0
Title
Heart rate
Description
Stress levels
Time Frame
Day 0
Title
STAI-6
Description
6-item Short State Trait Anxiety Inventory
Time Frame
Day 0
Title
Feeling scale
Description
Mood
Time Frame
Day 0
Title
Felt Arousal Scale
Description
Mood
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Lundberg, med. dent.
Phone
+41446343341
Email
andrea.lundberg@zzm.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Elena van der Heijden
Phone
+41446343341
Email
Elena.vanderHeijden@zzm.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murali Srinivasan
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Lundberg, med. dent.
Phone
+41446343341
Email
andrea.lundberg@zzm.uzh.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Presence of Aquarium in the Waiting Room of a Geriatric Dental Clinic
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