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
1 other identifier
interventional
120
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
March 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2020
CompletedFirst Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedMay 19, 2021
May 1, 2021
6 months
May 14, 2021
May 14, 2021
Conditions
Keywords
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
EXPERIMENTALDetailed visual video information was given to the video group patients before endodontic treatment by the clinician.
Control Group
EXPERIMENTALBasic verbal information was given to the control group patients before endodontic treatment by the clinician.
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.
Eligibility Criteria
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)
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: 28298978BACKGROUNDCaprara 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: 12929693BACKGROUNDKazancioglu 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
- STUDY DIRECTOR
Hicran Dönmez Özkan
Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics
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