Effectiveness of Green Color Exposure on Dental Anxiety

November 6, 2023 updated by: Gokhan Gurses, Selcuk University

Effectiveness of Green Color Exposure on Dental Anxiety for Third Molar Surgery

The investigator's aim in this study was to evaluate the preoperative anxiety and the pain felt during the operation due to exposure to green light. For this purpose, the participants will wear green or translucent glasses before the operation. The investigator will evaluate the patient's anxiety change and the pain she/he feels during the procedure.

Study Overview

Study Type

Interventional

Enrollment (Actual)

128

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
        • 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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Study Population

Study population is healthy volunteers who have not undergone any oral surgery procedure.

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Gökhan Gürses, Selcuk University, Faculty of Dentistry

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)

September 27, 2022

Primary Completion (Actual)

October 19, 2023

Study Completion (Actual)

October 26, 2023

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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

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.

Clinical Trials on Post Operative Pain

Clinical Trials on Green light exposure

3
Subscribe