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

Sponsor
T.C. ORDU ÜNİVERSİTESİ (Other)
Overall Status
Completed
CT.gov ID
NCT04613947
Collaborator
(none)
80
1
4
8.9
9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Informed consent
  • Procedure: Third molar surgery
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dental anxiety [at operation day (before and after consent and immedialtely after operation)]

    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.

Secondary Outcome Measures

  1. Salivary cortisol level [at operation day (before and after consent and immediately after operation)]

    The amount of cortisol in saliva samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ordu University Ordu Turkey 52200

Sponsors and Collaborators

  • T.C. ORDU ÜNİVERSİTESİ

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Damla Torul, Assistant Professor, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier:
NCT04613947
Other Study ID Numbers:
  • 2020/192
First Posted:
Nov 3, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022