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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Conditions the study is for
Stress, Anxiety, Mood
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.

Andrea Lundberg, med. dent. contact

+41446343341

andrea.lundberg@zzm.uzh.ch

Elena van der Heijden contact

+41446343341

Elena.vanderHeijden@zzm.uzh.ch

Switzerland1 site, 1 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

    Recruiting

Other trials in Switzerland

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.
Conditions
Stress, Anxiety, Mood
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 groups in NCT04630600
Study groupRoleWhat they receive
ControlOtherNormal waiting room
Receives: Other: No intervention
Intervention#1ExperimentalWaiting room with partially-equipped aquarium (without fish)
Receives: Other: Partially-equipped aquarium in the waiting area
Intervention#2ExperimentalWaiting 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.

  1. Blood pressure (systolic and diastolic)

    Stress levels

    Measured: Day 0

  2. Heart rate

    Stress levels

    Measured: Day 0

  3. STAI-6

    6-item Short State Trait Anxiety Inventory

    Measured: Day 0

  4. Feeling scale

    Mood

    Measured: Day 0

  5. 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.

  1. First posted16 Nov 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

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)
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

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.

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