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Evaluation of Verbal and Visual Information Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04017689
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 16, 2019
Information provided by (Responsible Party):
Funda Bastürk, Necmettin Erbakan University

Brief Summary:
The aim of this study is to evaluate the effects of preoperative and postoperative anxiety levels on patients using oral information, visual information with surgical photographs and visual information via audio-video. To evaluate anxiety levels, dental anxiety scale (DAS), modified dental anxiety scale (MDAS) and state anxiety scale (STAI-S, STAI-T) scales will be used.

Condition or disease

Detailed Description:

After giving written information about the study, an informed consent form will be distributed to patients who want to participate in the study and they will be asked to sign it. Patients who have signed the consent form will be asked to complete the DAS, MDAS, STAI-T and STAI-S questionnaires in the waiting room to assess preoperative anxiety levels.

Verbal, photos and video information used to inform patients. Patients will be randomly divided into 3 groups. A total of 60 patients with 20 patients in each group will be included in the study. Patients in all groups will be operated by the same surgeon. Oral information will be given to the patients in the first group. In the second group, visual information will be given to the patients by showing the photos of the operation process. Patients in group 3 will also be shown a video of an audio implant operation showing the operation process. The operation video of a previously implanted patient will be watched by the attending physician. This video will begin with the physician informing the patient about the implant and continue with anesthesia. Afterward, the video will be terminated by giving information about the implant operation video and the complications that the patient may encounter and the points to be considered after the operation.

A 7-day pain score will be obtained using the Smiley VAS scale to measure postoperative pain levels and patients will be asked to note how many painkillers they use. In addition, blood pressure and pulse measurements will be taken before and after surgery.

A common text was prepared in all groups in order to provide preoperative information in an ideal way. In group 1, information related to this text will be given orally. In the 2nd and 3rd groups, patients will be informed about the same information as well as visuality.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Verbal Information Group
Verbal Information
Photo Group
Information by photos
Video Group
Information by video

Primary Outcome Measures :
  1. anxiety scores [ Time Frame: before instruct about surgery and after instruct about surgery and postoperative 7th day ]
    State-Trait Anxiety Inventory (STAI) scale for state anxiety inculude 20 question trait anxiety and 20 question state anxiety.each question has a point value (1 to 5) and higher point indicate worse anxiety

  2. Visual analog scale (VAS) for pain [ Time Frame: immediatly postoperative and postoperative 7th day ]
    scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain

  3. dental anxiety scores [ Time Frame: before instruct about surgery and after instruct about surgery and postoperative 7th day ]
    Modified Dental Anxiety Scale (MDAS) for dental anxiety include five question, each questions has a point value (1 to 5) and higher point indicate worse anxiety

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients between the ages of 18-55, who will receive 1 or 2 implants

Inclusion Criteria:

  • Patients admitted to the investigator's clinic for implant surgery

Exclusion Criteria:

  • pregnant patients
  • patients using psychiatric drugs
  • patients with visual problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04017689

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Contact: Funda Baştürk, Dt 03322230026

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Necmettin Erbakan University Faculty of Dentistry Recruiting
Konya, Turkey
Contact: Funda Baştürk, Dt    03322230026   
Sponsors and Collaborators
Necmettin Erbakan University
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Study Chair: Dilek Menziletoglu, Dr Necmettin Erbakan University/Dentistry Faculty

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Responsible Party: Funda Bastürk, Master student and research assistant in Oral and Maxillofacial surgery, Necmettin Erbakan University Identifier: NCT04017689     History of Changes
Other Study ID Numbers: NecmettinEU2
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No