NCT05584696

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

September 27, 2022

Last Update Submit

November 6, 2023

Conditions

Outcome Measures

Primary Outcomes (11)

  • Pre-op Anxiety Score-1(VAS)

    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)

    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)

    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)

    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

  • Pre-op blood pressure-1

    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

    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

    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

    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

    heartbeat measurement by pulse oximeter. The avarage value is between 65-75.

    1 minute after the participant enters the clinic

  • Pre-op Pulsation-2

    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

  • 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

Study Arms (2)

Green Light Exposure Group

EXPERIMENTAL

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.

Other: Green light exposure

Control Group

PLACEBO COMPARATOR

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.

Other: Normal light exposure

Interventions

The experimental group wears green color glasses ten minutes before surgery until it ends.

Green Light Exposure Group

The control group wears green color glasses ten minutes before surgery until it ends.

Control 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 the VAS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Dentistry

Konya, Selçuklu, Turkey (Türkiye)

Location

Related Publications (1)

  • Gurses G, Omeroglu Akkoc FI, Akti A, Korez MK. Effectiveness of wearing glasses with green lenses on dental anxiety for third-molar surgery: A randomized clinical trial. J Am Dent Assoc. 2024 Jun;155(6):496-503.e1. doi: 10.1016/j.adaj.2024.02.006. Epub 2024 Mar 21.

MeSH Terms

Conditions

Anxiety DisordersPain, Postoperative

Condition Hierarchy (Ancestors)

Mental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gökhan Gürses

    Selcuk University, Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 18, 2022

Study Start

September 27, 2022

Primary Completion

October 19, 2023

Study Completion

October 26, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations