NCT04892394

Brief Summary

This study compared the effect of the detailed video visual information and basic verbal information on patients' anxiety levels (using anxiety scales) before endodontic treatment and stress levels (using electrodermal activity method) during endodontic treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 14, 2021

Last Update Submit

May 14, 2021

Conditions

Keywords

Video informationElectrodermal activityEndodontic treatment

Outcome Measures

Primary Outcomes (4)

  • Anxiety level comparison after endodontic treatment with two preoperative information types

    Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line.

    Immediately after treatment

  • Anxiety level comparison after endodontic treatment with two preoperative information types

    State Anxiety Scale (STAI-S) was used to assess anxiety levels. The STAI scales consisted of two scales, each with 20 questions, with a total score between 20 and 80. Every patient was asked to mark his or her perceived dental anxiety level on the line.

    Immediately after treatment

  • Anxiety level comparison after endodontic treatment with two preoperative information types

    The Visual Analogue Scale (VAS) was a scale consisting of a horizontal straight line 0-100 mm long with words describing the two extremes of the condition to be measured at both ends (i.e. zero - no anxiety, maximum - most severe anxiety). Every patient was asked to mark his or her perceived dental anxiety level on the line.

    Immediately after treatment

  • Electrodermal activity level comparison during endodontic treatment with two preoperative information types

    At the beginning of the endodontic treatment, the GSR device was attached to the patient's preferred wrist, and the measuring tapes of the device were placed on the patient's proximal phalanges of the index and middle finger. One-visit endodontic treatment was divided into 7 steps (anesthesia, cavity preparation, rubber dam placement, determination of root canal length, root canal shaping, root canal filling, coronal restoration and finishing) and recorded. All data transmitted to the computer via a wireless connection by a software program were recorded at the end of the treatment.

    During endodontic treatment process

Secondary Outcomes (4)

  • Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits

    Before Endodontic Treatment

  • Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits

    Before Endodontic Treatment

  • Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits

    Before Endodontic Treatment

  • Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits

    Before Endodontic Treatment

Other Outcomes (1)

  • Evaluation of patients satisfaction about information types

    Immediately after treatment

Study Arms (2)

Video Group

EXPERIMENTAL

Detailed visual video information was given to the video group patients before endodontic treatment by the clinician.

Other: Information Types Before Endodontic Treatment

Control Group

EXPERIMENTAL

Basic verbal information was given to the control group patients before endodontic treatment by the clinician.

Other: Information Types Before Endodontic Treatment

Interventions

The first aim of this study is to compare the effect of detailed video information or basic verbal information on the anxiety levels of patients by using anxiety scales before treatment. The second aim is to evaluate the effect of pretreatment video or verbal information on the stress level occurring in patients during the endodontic treatment steps by using electrodermal activity. The third aim is to investigate the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics which are thought to play a role in anxiety's etiology.

Control GroupVideo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 - 65 years of ages
  • Patients with healthy (ASA 1) and mild systemic disease (ASA 2) according to ASA classification
  • Patients with no mental disorders in their medical history
  • Patients who do not have a psychiatric disorder that they have started, and who do not use psychotherapeutic drugs.
  • Literate and not visually impaired patients
  • Patients presenting with single-rooted teeth with a single root canal diagnosed with asymptomatic irreversible pulpitis or single-rooted vital teeth with a single root canal requiring root canal treatment due to prosthetic reasons

You may not qualify if:

  • Patients who refuse to participate this study
  • Patients have existing pain caused by another tooth
  • Patients with dermatological disease in the medical histories
  • Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications)
  • The presence of spontaneous pain, swelling, or fistula in the relevant tooth
  • Teeth whose working length cannot be reached due to calcification and step formation in the root canal
  • The presence of foreign material in the root canal that prevents entry (broken instrument, post)
  • The presence of advanced periodontal disease (probing depth \> 4 mm) or root fracture in the relevant tooth
  • Patients using pain medication on the same day before treatment (within 24 hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (3)

  • Najafpour E, Asl-Aminabadi N, Nuroloyuni S, Jamali Z, Shirazi S. Can galvanic skin conductance be used as an objective indicator of children's anxiety in the dental setting? J Clin Exp Dent. 2017 Mar 1;9(3):e377-e383. doi: 10.4317/jced.53419. eCollection 2017 Mar.

    PMID: 28298978BACKGROUND
  • Caprara HJ, Eleazer PD, Barfield RD, Chavers S. Objective measurement of patient's dental anxiety by galvanic skin reaction. J Endod. 2003 Aug;29(8):493-6. doi: 10.1097/00004770-200308000-00001.

    PMID: 12929693BACKGROUND
  • Kazancioglu HO, Tek M, Ezirganli S, Demirtas N. Does watching a video on third molar surgery increase patients' anxiety level? Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Mar;119(3):272-7. doi: 10.1016/j.oooo.2014.10.012. Epub 2014 Nov 8.

    PMID: 25561389BACKGROUND

Study Officials

  • Hicran Dönmez Özkan

    Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 19, 2021

Study Start

March 12, 2020

Primary Completion

September 16, 2020

Study Completion

November 22, 2020

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations