Anxiety, DentalNCT05584696
Effectiveness of Green Color Exposure on Dental Anxiety
A study testing Green light exposure and Normal light exposure in people with Anxiety, Dental and Post Operative Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Dental, Post Operative Pain
- What is being tested?
- Green light exposure and Normal light exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2022to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 and ASA 2 patient population
- not having had a third molar surgery before
- volunteer to participate in the study
Who cannot join
- dental phobia
- patients who will be treated under general anesthesia
- refusing the measurements
- not filling the VAS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Dentistry
Konya, Selçuklu
About this study
Official title: 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.
- Conditions
- Anxiety, Dental, Post Operative Pain
- Being tested
- Green light exposure, Normal light exposure
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green light exposureOther
The experimental group wears green color glasses ten minutes before surgery until it ends.
Normal light exposureOther
The control group wears green color glasses ten minutes before surgery until it ends.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 minute after the participant enters the clinic
Pre-op blood pressure-2
Brachial tension measurement. ideally it should be 120-80 mm/hg.
Measured: 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.
Measured: 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.
Measured: 10 minutes after the glasses are put on
Pre-op Pulsation-1
heartbeat measurement by pulse oximeter. The avarage value is between 65-75.
Measured: 1 minute after the participant enters the clinic
Pre-op Pulsation-2
heartbeat measurement by pulse oximeter. The avarage value is between 65-75.
Measured: 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.
Measured: 1 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start27 Sep 2022
- Primary completion19 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety, DentalStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Gurses, Selcuk University
- Investigators
- Gökhan Gürses, Study chair, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584696
- Sponsor's protocol ID
- SelcukU001
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38520420
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Green Color Exposure on Dental Anxiety for Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05584696
- Acronym / sponsor ID
- SelcukU001
- Conditions
- Anxiety, Dental, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Light Exposure Group | Experimental | Other: Green light exposureWhen 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. |
| Control Group | Placebo comparator | Other: Normal light exposureWhen 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA 1 and ASA 2 patient population
- not having had a third molar surgery before
- volunteer to participate in the study
Key exclusion criteria (4 listed)
- dental phobia
- patients who will be treated under general anesthesia
- refusing the measurements
- not filling the VAS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green light exposureThe experimental group wears green color glasses ten minutes before surgery until it ends. | Other | Green Light Exposure Group |
| Normal light exposureThe control group wears green color glasses ten minutes before surgery until it ends. | Other | Control Group |
Primary outcome
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 38520420Gurses 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökhan Gürses study chair
Selcuk University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green light exposure and Normal light exposure in people with Anxiety, Dental and Post Operative Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-op Anxiety Score-1(VAS) (time frame: 1 minute after the participant enters the clinic). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05584696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.