Clinical trial NCT04892394: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Video information
Electrodermal activity
Endodontic treatment
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anxiety level comparison after endodontic treatment with two preoperative information types
timeFrame: Immediately after treatment
measure: Anxiety level comparison after endodontic treatment with two preoperative information types
timeFrame: Immediately after treatment
measure: Anxiety level comparison after endodontic treatment with two preoperative information types
timeFrame: Immediately after treatment
measure: Electrodermal activity level comparison during endodontic treatment with two preoperative information types
timeFrame: During endodontic treatment process
Secondary outcomes:
measure: Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
timeFrame: Before Endodontic Treatment
measure: Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
timeFrame: Before Endodontic Treatment
measure: Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
timeFrame: Before Endodontic Treatment
measure: Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits
timeFrame: Before Endodontic Treatment
Other outcomes:
measure: Evaluation of patients satisfaction about information types
timeFrame: Immediately after treatment
Locations:
city: Aydın
country: Turkey
facility: Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics
Study officials:
affiliation: Aydin Adnan Menderes University, Faculty of Dentistry, Department of Endodontics
name: Hicran Dönmez Özkan
role: STUDY_DIRECTOR
References:
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.
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.
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.