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NCT Number: NCT04892394

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

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.

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Key information

Conditions

Dental Anxiety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aydin, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Information Types Before Endodontic Treatment

Other

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 outcomes

  1. Anxiety level comparison after endodontic treatment with two preoperative information types

    Time frame: Immediately after treatment

    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.

  2. Anxiety level comparison after endodontic treatment with two preoperative information types

    Time frame: Immediately after treatment

    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.

  3. Anxiety level comparison after endodontic treatment with two preoperative information types

    Time frame: Immediately after treatment

    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.

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

    Time frame: During endodontic treatment process

    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 outcomes

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

    Time frame: Before Endodontic Treatment

    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.

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

    Time frame: Before Endodontic Treatment

    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.

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

    Time frame: Before Endodontic Treatment

    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.

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

    Time frame: Before Endodontic Treatment

    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.

Other outcomes

  1. Evaluation of patients satisfaction about information types

    Time frame: Immediately after treatment

    A feedback-satisfaction form containing 4 items about information types was applied to all patients after the endodontic treatment.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 19, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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