- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06452836
Colors, Can They Reduce the Dental Anxiety
April 17, 2026 updated by: Gokhan Gurses, Selcuk University
The investigator's aim in this study was to evaluate the preoperative anxiety and pain felt during the operation due to exposure to green, red, and blue light.
For this purpose, the participants will wear colored glasses before the operation.
The investigator will evaluate the patient's anxiety change and the pain she/he feels during the procedure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Selçuklu
-
Konya, Selçuklu, Turkey (Türkiye)
- Selcuk University, Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- ASA 1 and ASA 2 patient population
- not having had a third molar surgery before
- volunteer to participate in the study
Exclusion Criteria:
- dental phobia
- patients who will be treated under general anesthesia
- refusing the measurements
- not filling out the VAS
- encountering complications during surgery
- operations lasting more than 45 minutes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Green Colored Glasses Group
|
Patients will wear green colored glasses before and during the surgery.
|
|
Experimental: Red Colored Glasses Group
|
Patients will wear red colored glasses before and during the surgery.
|
|
Experimental: Blue Colored Glasses Group
|
Patients will wear blue colored glasses before and during the surgery.
|
|
Placebo Comparator: Translucent Glasses Group
|
Patients will wear translucent glasses before and during the surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Anxiety Score
Time Frame: 1 minute after the participant sits the dental unit and 10 minutes after
|
Patients complete the State-Trait Anxiety Inventory (STAI) while seated in the dental unit.
Ten minutes after the glasses are worn, patients fill out the anxiety scale again.
Changes in the scores are the primary outcome of the study.
The scale range is 20-40.
A lower score means better results.
|
1 minute after the participant sits the dental unit and 10 minutes after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Pain Score
Time Frame: 1 minutes after the surgery
|
Measuring the pain felt by the patient after the operation with the help of the visual analog scale.
The range of Scala is 0-10.
A lower score means better results.
|
1 minutes after the surgery
|
|
Change in the salivary cortisol level
Time Frame: 1 minute after the participant sits the dental unit and 10 minutes after
|
Measuring the salivary cortisol level one minute after the patient sits in the dental unit and after ten minutes.
Changes in the levels are the secondary outcome of the study.
|
1 minute after the participant sits the dental unit and 10 minutes after
|
|
Change in the oxygen saturation
Time Frame: 1 minute after the participant sits the dental unit and 10 minutes after
|
Saturation measurement is done from the fingertip using a pulse oximeter one minute after the patient sits in the dental unit and after ten minutes.
Changes in the scores are the secondary outcome of the study.
The average value is above %90.
|
1 minute after the participant sits the dental unit and 10 minutes after
|
|
Change in the pulsation
Time Frame: 1 minute after the participant sits the dental unit and 10 minutes after
|
Pulsation was measured from the fingertip by a pulse oximeter one minute after the patient sat in the dental unit and after ten minutes.
Changes in the scores are the secondary outcome of the study.
The average value is between 65 and 75.
|
1 minute after the participant sits the dental unit and 10 minutes after
|
|
Change in the salivary alfa-amilase level
Time Frame: 1 minute after the participant sits the dental unit and 10 minutes after
|
Measuring the salivary alfa-amylase level one minute after the patient sits in the dental unit and after ten minutes.
Changes in the levels are the secondary outcome of the study.
|
1 minute after the participant sits the dental unit and 10 minutes after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gökhan Gürses, Selcuk University, Faculty of Dentistry
- Principal Investigator: İsmail Okumuş, Selcuk University, Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Actual)
September 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
June 5, 2024
First Submitted That Met QC Criteria
June 10, 2024
First Posted (Actual)
June 11, 2024
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukU004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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