Back to resultsEffect of Video Information on the Dental Anxiety Levels of the Endodontic Patients
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Information Types Before Endodontic Treatment
Sponsored by
About this trial
This is an interventional prevention trial for Dental Anxiety focused on measuring Video information, Electrodermal activity, Endodontic treatment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Video Group
Control Group
Arm Description
Detailed visual video information was given to the video group patients before endodontic treatment by the clinician.
Basic verbal information was given to the control group patients before endodontic treatment by the clinician.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04892394
First Posted
May 14, 2021
Last Updated
May 14, 2021
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT04892394
Brief Title
Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients
Official Title
Determining the Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
November 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
Video information, Electrodermal activity, Endodontic treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video Group
Arm Type
Experimental
Arm Description
Detailed visual video information was given to the video group patients before endodontic treatment by the clinician.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Basic verbal information was given to the control group patients before endodontic treatment by the clinician.
Intervention Type
Other
Intervention Name(s)
Information Types Before Endodontic Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety level comparison after endodontic treatment with two preoperative information types
Description
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.
Time Frame
Immediately after treatment
Title
Anxiety level comparison after endodontic treatment with two preoperative information types
Description
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.
Time Frame
Immediately after treatment
Title
Anxiety level comparison after endodontic treatment with two preoperative information types
Description
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.
Time Frame
Immediately after treatment
Title
Electrodermal activity level comparison during endodontic treatment with two preoperative information types
Description
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.
Time Frame
During endodontic treatment process
Secondary Outcome Measure Information:
Title
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
Description
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.
Time Frame
Before Endodontic Treatment
Title
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
Description
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.
Time Frame
Before Endodontic Treatment
Title
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
Description
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.
Time Frame
Before Endodontic Treatment
Title
Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
Description
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.
Time Frame
Before Endodontic Treatment
Other Pre-specified Outcome Measures:
Title
Evaluation of patients satisfaction about information types
Description
A feedback-satisfaction form containing 4 items about information types was applied to all patients after the endodontic treatment.
Time Frame
Immediately after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicran Dönmez Özkan
Organizational Affiliation
Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics
Official's Role
Study Director
Facility Information:
Facility Name
Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics
City
Aydın
ZIP/Postal Code
09100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28298978
Citation
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.
Results Reference
background
PubMed Identifier
12929693
Citation
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.
Results Reference
background
PubMed Identifier
25561389
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients
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