NCT04017689

Brief Summary

The aim of this study is to evaluate the effects of preoperative and postoperative anxiety levels on patients using oral information, visual information with surgical photographs and visual information via audio-video. To evaluate anxiety levels, dental anxiety scale (DAS), modified dental anxiety scale (MDAS) and state anxiety scale (STAI-S, STAI-T) scales will be used.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

July 2, 2019

Last Update Submit

May 14, 2020

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

  • anxiety scores

    State-Trait Anxiety Inventory (STAI) scale for state anxiety inculude 20 question trait anxiety and 20 question state anxiety.each question has a point value (1 to 5) and higher point indicate worse anxiety

    before instruct about surgery and after instruct about surgery and postoperative 7th day

  • Visual analog scale (VAS) for pain

    scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain

    immediatly postoperative and postoperative 7th day

  • dental anxiety scores

    Modified Dental Anxiety Scale (MDAS) for dental anxiety include five question, each questions has a point value (1 to 5) and higher point indicate worse anxiety

    before instruct about surgery and after instruct about surgery and postoperative 7th day

Study Arms (3)

Verbal Information Group

Verbal Information

Photo Group

Information by photos

Video Group

Information by video

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18-55, who will receive 1 or 2 implants

You may qualify if:

  • Patients admitted to the investigator's clinic for implant surgery

You may not qualify if:

  • pregnant patients
  • patients using psychiatric drugs
  • patients with visual problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Faculty of Dentistry

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Dilek Menziletoglu, Dr

    Necmettin Erbakan University/Dentistry Faculty

    STUDY CHAIR

Central Study Contacts

Funda Baştürk, Dt

CONTACT

03322230026dtfunda.basturk@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student and research assistant in Oral and Maxillofacial surgery

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 12, 2019

Study Start

January 1, 2019

Primary Completion

May 1, 2020

Study Completion

June 14, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)