NCT06452836

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

June 5, 2024

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the Anxiety Score

    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 Outcomes (5)

  • Change in the oxygen saturation

    1 minute after the participant sits the dental unit and 10 minutes after

  • Change in the pulsation

    1 minute after the participant sits the dental unit and 10 minutes after

  • Intraoperative Pain Score

    1 minutes after the surgery

  • Change in the salivary cortisol level

    1 minute after the participant sits the dental unit and 10 minutes after

  • Change in the salivary alfa-amilase level

    1 minute after the participant sits the dental unit and 10 minutes after

Study Arms (4)

Translucent Glasses Group

PLACEBO COMPARATOR
Other: control

Green Colored Glasses Group

EXPERIMENTAL
Other: Green color exposure

Red Colored Glasses Group

EXPERIMENTAL
Other: Red color exposure

Blue Colored Glasses Group

EXPERIMENTAL
Other: Blue color exposure

Interventions

Patients will wear green colored glasses before and during the surgery.

Green Colored Glasses Group
controlOTHER

Patients will wear translucent glasses before and during the surgery.

Translucent Glasses Group

Patients will wear red colored glasses before and during the surgery.

Red Colored Glasses Group

Patients will wear blue colored glasses before and during the surgery.

Blue Colored Glasses Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1 and ASA 2 patient population
  • not having had a third molar surgery before
  • volunteer to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Dentistry

Konya, Selçuklu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Gökhan Gürses

    Selcuk University, Faculty of Dentistry

    STUDY CHAIR
  • İsmail Okumuş

    Selcuk University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 11, 2024

Study Start

February 1, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations