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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06452836
Other study ID # SelcukU004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date October 20, 2024

Study information

Verified date June 2024
Source Selcuk University
Contact Gökhan Gürses
Phone +905052595359
Email gokhangurses.akademik@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 20, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
Green color exposure
Patients will wear green colored glasses before and during the surgery.
Red color exposure
Patients will wear red colored glasses before and during the surgery.
Blue color exposure
Patients will wear blue colored glasses before and during the surgery.
control
Patients will wear translucent glasses before and during the surgery.

Locations

Country Name City State
Turkey Selcuk University, Faculty of Dentistry Konya Selçuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Anxiety Score Patients fill out the Dental Anxiety Scale(Visual Analogue Scale) when they sit 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 0-10. A lower score means better results. 1 minute after the participant sits the dental unit and 10 minutes after
Secondary Change in the oxygen saturation 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
Secondary Change in the pulsation 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
Secondary Intraoperative Pain Score 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
Secondary Change in the salivary cortisol level 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
Secondary Change in the salivary alfa-amilase level 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
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