Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery

Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery

The aim of this study is to investigate the effect of information provided in accordance with intelligence type on anxiety associated with wisdom tooth surgery.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Informed consent; Procedure: Third molar surgery

Detailed Description

The participants who will undergo third molar surgery divided into study and control groups. Study group divided further into three groups according to multiple intellegence test. Ultimately four groups created as follows;

1. Control: The group with standard (written and verbal) information without multiple intelligence test
2. Visual/Spatial: The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document.
3. Verbal/Linguistic: The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document
4. Bodily/Kinesthetic: The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document To evaluate anxiety; participants will asked to complete MDAS questionnairre before and after consent, and after operation. Also, saliva samples will obtained to evaluate the salivary cortisol before and after consent, and after operation.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52200
    • Ordu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with mandibular third molar tooth in vertical or mesioangular position according to Winter classification, class I and II ramus relationship according to Pell-Gregory classification and class B and C depth
• Patients who maintain their normal sleep patterns,
• Patients with ASA I status according to the American Society of Anesthesiologists (ASA) classification.

Exclusion Criteria:

• Patients did not agree to be a volunteer, and/or refused to watch videos or receive information in a different way from the standard procedure,
• Habits of Smoking and alcohol
• Patients who are pregnant or in the lactation period,
• Patients unable to cooperate,
• Patients having a psychiatric illness,
• Patients with systemic disease (local or systemic factors affecting salivary gland function, can cause changes in endocrine response)
• Patients using chronic medication and drugs that affect salivary cortisol levels, such as androgens, estrogens and corticosteroids.
• Patients with pericoronitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The group with standard (written and verbal) information without multiple intelligence test	Behavioral: Informed consent; The style of informing patients about the procedure they will undergo; Procedure: Third molar surgery; Surgical extraction of the third molar tooth
Experimental: Visual/Spatial: The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document	Behavioral: Informed consent; The style of informing patients about the procedure they will undergo; Procedure: Third molar surgery; Surgical extraction of the third molar tooth
Experimental: Verbal/Linguistic; The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document	Behavioral: Informed consent; The style of informing patients about the procedure they will undergo; Procedure: Third molar surgery; Surgical extraction of the third molar tooth
Experimental: Bodily/Kinesthetic; The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document	Behavioral: Informed consent; The style of informing patients about the procedure they will undergo; Procedure: Third molar surgery; Surgical extraction of the third molar tooth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental anxiety	Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS) MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.	at operation day (before and after operation and immediately after consent)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cortisol level	The amount of cortisol in saliva samples	at operation day (before and after operation and immediately after consent)

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Investigators: Principal Investigator: damla torul, DDS PhD, T.C. ORDU ÜNİVERSİTESİ; Study Director: mehmet M ömezli, DDS PhD, T.C. ORDU ÜNİVERSİTESİ

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 31, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2020/192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No