NCT03752255

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

December 26, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

November 21, 2018

Last Update Submit

December 24, 2018

Conditions

Impacted Third Molar Tooth

Keywords

VideoAnxiety

Outcome Measures

Primary Outcomes (1)

  • The anxiety levels will be examined using DAS and STAI.

    first day

    first day

Study Arms (2)

Anxiety measurement method

EXPERIMENTAL

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.

Other: Anxiety measurement method

Control

PLACEBO COMPARATOR

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.

Other: Anxiety measurement method

Interventions

Anxiety measurement methodOTHER

Two different techniques (video or verbal information) will be examined about impacted third molar surgery.

Anxiety measurement methodControl

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Karatay, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Dilek Menziletoglu, Dr

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 23, 2018

Study Start

November 21, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

December 26, 2018

Record last verified: 2018-11

Locations

TU(1)