Clinical trial NCT04017689: Evaluation of Verbal and Visual Information Techniques
Official title: THE ASSESSMENT OF THE EFFECTS OF DIFFERENT INFORMATION TECHNIQUES ON PATIENTS ANXIETY LEVELS IN IMPLANT SURGERY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-55, who will receive 1 or 2 implants

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: anxiety scores
timeFrame: before instruct about surgery and after instruct about surgery and postoperative 7th day
measure: Visual analog scale (VAS) for pain
timeFrame: immediatly postoperative and postoperative 7th day
measure: dental anxiety scores
timeFrame: before instruct about surgery and after instruct about surgery and postoperative 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University Faculty of Dentistry
Study officials:
affiliation: Necmettin Erbakan University/Dentistry Faculty
name: Dilek Menziletoglu, Dr
role: STUDY_CHAIR
References: