AnxietyNCT04017689
Evaluation of Verbal and Visual Information Techniques
An observational study of Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anxiety
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 14 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: Patients between the ages of 18-55, who will receive 1 or 2 implants
Who may be able to join
- Patients admitted to the investigator's clinic for implant surgery
Who cannot join
- pregnant patients
- patients using psychiatric drugs
- patients with visual problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University Faculty of Dentistry
Konya
Funda Baştürk, Dt, 03322230026, dtfunda.basturk@gmail.com
About this study
Official title: THE ASSESSMENT OF THE EFFECTS OF DIFFERENT INFORMATION TECHNIQUES ON PATIENTS ANXIETY LEVELS IN IMPLANT SURGERY
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.
Read the 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.
- Conditions
- Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Verbal Information Group | Verbal Information | |
| Photo Group | Information by photos | |
| Video Group | Information by video |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety scores
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
Measured: before instruct about surgery and after instruct about surgery and postoperative 7th day
Visual analog scale (VAS) for pain
scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain
Measured: immediatly postoperative and postoperative 7th day
dental anxiety scores
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
Measured: before instruct about surgery and after instruct about surgery and postoperative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Jan 2019
- Primary completion1 May 2020
- Study completion14 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Bastürk, Necmettin Erbakan University
- Investigators
- Dilek Menziletoglu, Dr, Study chair, Necmettin Erbakan University/Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017689
- Sponsor's protocol ID
- NecmettinEU2
- Status last verified
- May 2020
- First submitted
- 2 Jul 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ASSESSMENT OF THE EFFECTS OF DIFFERENT INFORMATION TECHNIQUES ON PATIENTS ANXIETY LEVELS IN IMPLANT SURGERY
- ClinicalTrials.gov ID
- NCT04017689
- Acronym / sponsor ID
- NecmettinEU2
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 14 Jun 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verbal Information Group | – | –Verbal Information |
| Photo Group | – | –Information by photos |
| Video Group | – | –Information by video |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients between the ages of 18-55, who will receive 1 or 2 implants
Key inclusion criteria (1 listed)
- Patients admitted to the investigator's clinic for implant surgery
Key exclusion criteria (3 listed)
- pregnant patients
- patients using psychiatric drugs
- patients with visual problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Menziletoglu, Dr study chair
Necmettin Erbakan University/Dentistry Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Funda Baştürk, Dt (03322230026, dtfunda.basturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety scores (time frame: before instruct about surgery and after instruct about surgery and postoperative 7th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.