NCT04630600

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

November 3, 2020

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Blood pressure (systolic and diastolic)

    Stress levels

    Day 0

  • Heart rate

    Stress levels

    Day 0

  • STAI-6

    6-item Short State Trait Anxiety Inventory

    Day 0

  • Feeling scale

    Mood

    Day 0

  • Felt Arousal Scale

    Mood

    Day 0

Study Arms (3)

Control

OTHER

Normal waiting room

Other: No intervention

Intervention#1

EXPERIMENTAL

Waiting room with partially-equipped aquarium (without fish)

Other: Partially-equipped aquarium in the waiting area

Intervention#2

EXPERIMENTAL

Waiting room with fully-equipped aquarium (with fish)

Other: Fully-equipped aquarium in the waiting area

Interventions

Normal waiting room without an aquarium

Control

Waiting room with a partially-equipped Aquarium

Intervention#1

Waiting room with a fully-equipped Aquarium

Intervention#2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years
  • Able to give informed consent as documented by signature.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Murali Srinivasan

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Lundberg, med. dent.

CONTACT

Elena van der Heijden

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 16, 2020

Study Start

July 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations