Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients

Determining the Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Information Types Before Endodontic Treatment

Detailed Description

Patients (n=120) aged between 18-65 with single-rooted teeth with the single canal that diagnosed with asymptomatic irreversible pulpitis and/or pre-prosthetic root canal treatment were included in this study. Patients were randomly divided into two groups after completing anxiety scales and socio-demographic/dental habits form. Before the treatment, visual video information was given to the video group patients, while the control group patients were routinely informed verbally. The stress levels during the endodontic treatment process were recorded by placing a electrodermal activity measurement device on the wrists of the patients. Anxiety scales and feedback-satisfaction forms were administered to all patients after the treatment process.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients between 18 - 65 years of ages
2. Patients with healthy (ASA 1) and mild systemic disease (ASA 2) according to ASA classification
3. Patients with no mental disorders in their medical history
4. Patients who do not have a psychiatric disorder that they have started, and who do not use psychotherapeutic drugs.
5. Literate and not visually impaired patients
6. 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Group; Detailed visual video information was given to the video group patients before endodontic treatment by the clinician.	Other: Information Types Before Endodontic Treatment; 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.
Experimental: Control Group; Basic verbal information was given to the control group patients before endodontic treatment by the clinician.	Other: Information Types Before Endodontic Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits	The patients were asked to fill in anxiety scales and sociodemographic/dental habits forms. 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.	Before Endodontic Treatment
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits	The patients were asked to fill in anxiety scales and sociodemographic/dental habits forms. State Anxiety Scale (STAI-S) was used to assess anxiety levels. The STAI-S 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.	Before Endodontic Treatment
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits	The patients were asked to fill in anxiety scales and sociodemographic/dental habits forms. Trait Anxiety Scale (STAI-T) was used to assess anxiety levels. The STAI-T 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.	Before Endodontic Treatment
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits	The patients were asked to fill in anxiety scales and sociodemographic/dental habits forms. 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.	Before Endodontic Treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of patients satisfaction about information types	A feedback-satisfaction form containing 4 items about information types was applied to all patients after the endodontic treatment.	Immediately after treatment

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Director: Hicran Dönmez Özkan, Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): November 22, 2020

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Electrodermal activity; Endodontic treatment; Video information
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ADÜDHF 2019/071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No