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Completed

NCT Number: NCT03889691

Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery

Third molar extraction is the most common surgical procedure in the field of oral and maxillofacial surgery and usually cause anxiety. Although different informed consent methods have been used previously, the most effective information method that provide the optimum anxiety management is still not clear. Therefore, investigators planned a clinical study to explore the effect of different information formats (verbal information with written document and verbal information with written document subsequent to watching video from internet) on peri-operative anxiety of the participants who scheduled to undergo impacted lower third molar surgery. Also, investigators aimed to explore the effect internet usage before the third molar surgery on the level of anxiety.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordu University

Ordu, 52200, Turkey (Türkiye)

About this study

The participants were randomly divided into two groups. The control group consisted of participants who informed verbally about the surgical procedure and the potential postoperative complications,. Also, a written informed consent document was given. Participants in the study group were asked to watch a video which was previously uploaded to the internet and was showed procedural details of an impacted right lower third molar extraction (with permission and written consent). Participants in the study group were also informed verbally about the surgical procedure-possible postoperative complications and was given with a written informed consent document. In both groups questions of the participants were answered by the same surgeon. To evaluate anxiety; participants were asked to complete 3 questionnaires one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure.

Who can participate

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

Inclusion criteria

patients;

  • without systemic disease,
  • have indication for third molar extraction,
  • radiographic degree of impaction according to the classification of Winter (vertical and mesio-angular) and the classification of Pell and Gregory 2, or 3 and B

Exclusion criteria

patients who;

  • has psychiatric illness and systemic disease,
  • refused to watch the video,
  • failed to fill out the forms for any reason,
  • had incomplete data and wanted to withdraw from the study,
  • had underwent a previous third molar surgery,
  • had history of anxiety attacks and/or anxiolytic treatment,
  • had unpleasant dental treatment experience could not cooperated,

Treatment and study plan

Third molar surgery

Procedure

Surgical extraction of impacted lower third molar tooth under local anesthesia

Primary outcomes

  1. Anxiety change being assessed with Spielberger State Anxiety Inventory (STAI-S)

    Time frame: one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

    There are total 40 questions in STAI-S (20). For each question the patients score ranged from 1 (almost never) to 4 (almost always) points. The sum of the scores range from 20-80. The score between 36 to 41 refer the mean anxiety level, and the values above 41 classified as high level of anxiety.

  2. Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS)

    Time frame: one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

    MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.

  3. Anxiety change being assessed with Amsterdam Preoperative Anxiety Inventory (APAIS)

    Time frame: one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

    APAIS is a scale consisting of 6 items, 3 of them are related to anesthesia and the others related to surgical procedure. The scoring ranges from 6 to 30 in total. The value of >11 is considered as high-anxiety level.

  4. Trait Anxiety assessed with Spielberger Trait Anxiety Inventory (STAI-T)

    Time frame: one week before the procedure

    There are total 40 questions in d STAI-T (20). For each question the patients score ranged from 1 (almost never) to 4 (almost always) points. The sum of the scores range from 20-80. The score between 36 to 41 refer the mean anxiety level, and the values above 41 classified as high level of anxiety.

Secondary outcomes

  1. Pain severity change

    Time frame: 1st, 3rd and 7th day after surgery

    Pain measured with Visual Analog scale (VAS) The pain levels of the patients were evaluated by a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extremely pain).

  2. Analgesic consumption per day

    Time frame: 1st, 3rd and 7th day after surgery

    Amount of analgesic consumption. High consumption show worse recovery

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Mar 26, 2019

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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