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Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anxiety measurement method
Sponsored by
Konya Necmettin Erbakan Üniversitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Impacted Third Molar Tooth focused on measuring Video, Anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Impacted third molar (bone and mucosa retention, mesioangular position)
  • Patients with any chronic disease and allergy

Exclusion Criteria:

  • Pericoronitis
  • Patients with visual impairment
  • Patients with psychological disorders
  • Smoking
  • Pregnancy or lactation

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anxiety measurement method

Control

Arm Description

Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). Then patients will watch a video about impacted tooth. This video will include the complications that patients may face and what should be done after the procedure. After the watching the video, patients will fill the both DAS and STAI.

Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). The verbal information in detail will be given to the patients by the surgeon.This verbal information will include the complications that patients may face and what should be done after the procedure.

Outcomes

Primary Outcome Measures

The anxiety levels will be examined using DAS and STAI.
first day

Secondary Outcome Measures

Full Information

First Posted
November 21, 2018
Last Updated
December 24, 2018
Sponsor
Konya Necmettin Erbakan Üniversitesi
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1. Study Identification

Unique Protocol Identification Number
NCT03752255
Brief Title
Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery
Official Title
The Effects of Verbal and Visual Information Techniques on Anxiety in Impacted Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Necmettin Erbakan Üniversitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).
Detailed Description
This study will based on a prospective, observational investigation of two different patient education techniques about the effect of third molar removal on patients' anxiety level. A total of 240 patients will be divided into two groups. Information about operation procedures and a recovery will be given verbally in group 1 and information about operation procedures and recovery will be given in group 2. Anxiety levels were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for intra-group comparison of anxiety levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
Video, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxiety measurement method
Arm Type
Experimental
Arm Description
Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). Then patients will watch a video about impacted tooth. This video will include the complications that patients may face and what should be done after the procedure. After the watching the video, patients will fill the both DAS and STAI.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). The verbal information in detail will be given to the patients by the surgeon.This verbal information will include the complications that patients may face and what should be done after the procedure.
Intervention Type
Other
Intervention Name(s)
Anxiety measurement method
Intervention Description
Two different techniques (video or verbal information) will be examined about impacted third molar surgery.
Primary Outcome Measure Information:
Title
The anxiety levels will be examined using DAS and STAI.
Description
first day
Time Frame
first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Impacted third molar (bone and mucosa retention, mesioangular position) Patients with any chronic disease and allergy Exclusion Criteria: Pericoronitis Patients with visual impairment Patients with psychological disorders Smoking Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Menziletoglu, Dr
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
State/Province
Karatay
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery

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