- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05584696
Effectiveness of Green Color Exposure on Dental Anxiety
Effectiveness of Green Color Exposure on Dental Anxiety for Third Molar Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
-
Konya, Selçuklu, Turkey
- Selcuk University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
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 the VAS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Green Light Exposure Group
When patients enter the clinic, toss a coin to determine which group they will belong to. Before the patient puts on the green glasses, the anxiety level is measured with the help of VAS. Then the patient is seated in the dental unit and green glasses will be put on. After 10 minutes the anxiety level will be measured again with the help of VAS. The level of pain felt during surgery was determined by VAS. All operations will be performed by a single experienced surgeon. Since the patients enter the clinic, their heart rate, oxygen saturation and blood pressure will be measured continuously. |
The experimental group wears green color glasses ten minutes before surgery until it ends.
|
Placebo Comparator: Control Group
When patients enter the clinic, toss a coin to determine which group they will belong to. Before the patient puts on transparent glasses, the anxiety level is measured with the help of VAS. Then the patient is seated in the dental unit and transparent glasses will be put on. After 10 minutes the anxiety level will be measured again with the help of VAS. The level of pain felt during surgery was determined by VAS. All operations will be performed by a single experienced surgeon. Since the patients enter the clinic, their heart rate, oxygen saturation and blood pressure will be measured continuously. |
The control group wears green color glasses ten minutes before surgery until it ends.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-op blood pressure-1
Time Frame: 1 minute after the participant enters the clinic
|
Brachial tension measurement.
ideally it should be 120-80 mm/hg.
Çeviri sonuçları After the patient enters the clinic
|
1 minute after the participant enters the clinic
|
Pre-op blood pressure-2
Time Frame: 10 minutes after the glasses are put on
|
Brachial tension measurement.
ideally it should be 120-80 mm/hg.
|
10 minutes after the glasses are put on
|
Pre-op blood oxygen level-1
Time Frame: 1 minute after the participant enters the clinic
|
saturation measurement from finger tip by pulse oximeter.
The avarage value is above %90.
|
1 minute after the participant enters the clinic
|
Pre-op blood oxygen level-2
Time Frame: 10 minutes after the glasses are put on
|
saturation measurement from finger tip by pulse oximeter.
The avarage value is above %90.
|
10 minutes after the glasses are put on
|
Pre-op Pulsation-1
Time Frame: 1 minute after the participant enters the clinic
|
heartbeat measurement by pulse oximeter.
The avarage value is between 65-75.
|
1 minute after the participant enters the clinic
|
Pre-op Pulsation-2
Time Frame: 10 minutes after the glasses are put on and the patient sits in the chair
|
heartbeat measurement by pulse oximeter.
The avarage value is between 65-75.
|
10 minutes after the glasses are put on and the patient sits in the chair
|
Pre-op Anxiety Score-1(VAS)
Time Frame: 1 minute after the participant enters the clinic
|
Patients fill out the Dental Anxiety Scale(Visual Analogue Scale) when he/she arrives dental clinic.
The range of Scala is 0-10.
A lower score means better results.
|
1 minute after the participant enters the clinic
|
Pre-op Anxiety Score-1(STAI-State)
Time Frame: 1 minute after the participant enters the clinic
|
Patients fill out the State-Trait Anxiety Inventory-State when he/she arrives dental clinic.
The range of Scala is 0-10.
A lower score means better results.
|
1 minute after the participant enters the clinic
|
Pre-op Anxiety Score-2(VAS)
Time Frame: 10 minutes after the glasses put on
|
Patients fill out the Dental Anxiety Scale(Visual Analogue Scale) ten minutes after wearing green or translucent glasses in the dental unit.
The range of Scala is 0-10.
A lower score means better results.
|
10 minutes after the glasses put on
|
Pre-op Anxiety Score-2(STAI-State)
Time Frame: 10 minutes after the glasses put on
|
Patients fill out the State-Trait Anxiety Inventory-State ten minutes after wearing green or translucent glasses in the dental unit.
The range of Scala is 0-10.
A lower score means better results.
|
10 minutes after the glasses put on
|
Intraoperative Pain Score
Time Frame: 1 minutes after
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gökhan Gürses, Selcuk University, Faculty of Dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukU001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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