StressNCT04630600
Presence of Aquarium in the Waiting Room of a Geriatric Dental Clinic
A study testing Partially-equipped aquarium in the waiting area and Fully-equipped aquarium in the waiting area in people with Stress and Anxiety, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Partially-equipped aquarium in the waiting area and Fully-equipped aquarium in the waiting area
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years
- Able to give informed consent as documented by signature.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich
Zurich, Canton of Zurich, 8032
Andrea Lundberg, med. dent., +41446343341, andrea.lundberg@zzm.uzh.ch
About this study
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
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.
Read the 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.
- Being tested
- No intervention, Partially-equipped aquarium in the waiting area, Fully-equipped aquarium in the waiting area
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Normal waiting room without an aquarium
Partially-equipped aquarium in the waiting areaOther
Waiting room with a partially-equipped Aquarium
Fully-equipped aquarium in the waiting areaOther
Waiting room with a fully-equipped Aquarium
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Normal waiting room Receives: Other: No intervention |
| Intervention#1 | Experimental | Waiting room with partially-equipped aquarium (without fish) Receives: Other: Partially-equipped aquarium in the waiting area |
| Intervention#2 | Experimental | Waiting room with fully-equipped aquarium (with fish) Receives: Other: Fully-equipped aquarium in the waiting area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (systolic and diastolic)
Stress levels
Measured: Day 0
Heart rate
Stress levels
Measured: Day 0
STAI-6
6-item Short State Trait Anxiety Inventory
Measured: Day 0
Feeling scale
Mood
Measured: Day 0
Felt Arousal Scale
Mood
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jul 2020
- Primary completion1 Jun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murali Srinivasan, University of Zurich
- Investigators
- Murali Srinivasan, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630600
- Sponsor's protocol ID
- UZH_ABS_2020_1
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04630600
- Acronym / sponsor ID
- UZH_ABS_2020_1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: No interventionNormal waiting room |
| Intervention#1 | Experimental | Other: Partially-equipped aquarium in the waiting areaWaiting room with partially-equipped aquarium (without fish) |
| Intervention#2 | Experimental | Other: Fully-equipped aquarium in the waiting areaWaiting room with fully-equipped aquarium (with fish) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years
- Able to give informed consent as documented by signature.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNormal waiting room without an aquarium | Other | Control |
| Partially-equipped aquarium in the waiting areaWaiting room with a partially-equipped Aquarium | Other | Intervention#1 |
| Fully-equipped aquarium in the waiting areaWaiting room with a fully-equipped Aquarium | Other | Intervention#2 |
Primary outcome
Blood pressure (systolic and diastolic)
Time frame: Day 0
Stress levels
Heart rate
Time frame: Day 0
Stress levels
STAI-6
Time frame: Day 0
6-item Short State Trait Anxiety Inventory
Feeling scale
Time frame: Day 0
Mood
Felt Arousal Scale
Time frame: Day 0
Mood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murali Srinivasan principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially-equipped aquarium in the waiting area and Fully-equipped aquarium in the waiting area in people with Stress and Anxiety, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Lundberg, med. dent. (+41446343341, andrea.lundberg@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (systolic and diastolic) (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.