Preoperative AnxietyNCT07394881
Visual Tools and Preoperative Anxiety in Orthognathic Surgery
A study testing Verbal İnformation, Animation Video Counseling and 3-D Skull Model Counseling in people with Preoperative Anxiety and Orthognathic Surgical Procedures, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether adding visual tools to standard preoperative counseling can reduce anxiety in patients scheduled for bimaxillary orthognathic surgery. Participants aged 18-36 years undergoing elective surgery was randomly assigned to one of three groups: (1) standard verbal information, (2) standard… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Orthognathic Surgical Procedures
- What is being tested?
- Verbal İnformation, Animation Video Counseling and 3-D Skull Model Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults (≥18 years).
- Scheduled to undergo elective bimaxillary orthognathic surgery under general anesthesia.
- Able to understand the study procedures and complete the anxiety questionnaires.
- Provided written informed consent.
Who cannot join
- Current diagnosis of a major psychiatric disorder or use of anxiolytic/antidepressant medication that could affect anxiety assessment.
- Cognitive impairment or inability to complete the questionnaires.
- Emergency surgery.
- Refusal to participate or withdrawal of consent.
- Any condition judged by the investigator to interfere with participation or outcome assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Video Animations and 3-D Skull Models Reduce Preoperative Anxiety in Bimaxillary Orthognathic Surgery Patients? Single Blinded Randomized Controlled Trial
This study evaluates whether adding visual tools to standard preoperative counseling can reduce anxiety in patients scheduled for bimaxillary orthognathic surgery. Participants aged 18-36 years undergoing elective surgery was randomly assigned to one of three groups: (1) standard verbal information, (2) standard verbal information with a short animation video, (3) standard verbal information with a 3-D anatomical skull model demonstration. Anxiety was assessed using the State-Trait Anxiety Inventory and a visual analog scale at two time points: before the information session and approximately one hour before surgery. The goal is to determine whether visual tools provide additional benefit beyond standard counseling in reducing preoperative anxiety.
Read the detailed description
This was a single-center, randomized, parallel-group study assessing the effect of different counseling tools on preoperative anxiety in patients undergoing elective bimaxillary orthognathic surgery. All participants received standardized verbal preoperative information delivered in a consistent setting. Group A received verbal information only; Group B received verbal information supplemented with an animation video; and Group C received verbal information supplemented with a 3-D anatomical skull model demonstration. Information sessions were standardized and lasted approximately 10 minutes. Anxiety was measured using the STAI (state and trait components) and a VAS at two predefined time points: baseline (before the information session) and approximately one hour before surgery. The main comparisons were changes in anxiety scores between groups to evaluate whether visual tools reduced preoperative anxiety beyond standard counseling. Data collection of anxiety assessments was performed by blinded personnel, and ethical approval and written informed consent were obtained.
- Being tested
- Verbal İnformation, Animation Video Counseling, 3-D Skull Model Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal İnformationBehavioural
Standardized preoperative verbal information provided to all participants.
Animation Video CounselingBehavioural
Standardized preoperative verbal counseling supplemented with an animation video explaining the surgical procedure and potential complications.
3-D Skull Model CounselingBehavioural
Standardized preoperative verbal counseling supplemented with a 3-D anatomical skull model demonstration to explain surgical anatomy and the planned procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standardized verbal preoperative information. Receives: Behavioral: Verbal İnformation |
| Video Animation Tools | Experimental | animation video used as a visual tool during counseling. Receives: Behavioral: Animation Video Counseling |
| 3D-Head Skull Tools | Experimental | Anatomical skull model demonstration used as a visual tool during counseling. Receives: Behavioral: 3-D Skull Model Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for Anxiety (VAS-A)
Change in preoperative anxiety level measured using the Visual Analogue Scale for Anxiety (VAS-A). The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).
Measured: From baseline (before preoperative counseling) to immediately before surgery
State-Trait Anxiety Inventory
Change in state anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The overall (total) score for STAI ranges from a minimum of 20 to a maximum of 80; STAI scores are commonly classified as 'no or low anxiety' (20-37), 'moderate anxiety' (38-44), and 'high anxiety' (45-80)
Measured: From baseline (before preoperative counseling) to immediately before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group randomized study comparing standard counseling alone versus counseling supplemented with a video animation or a 3-D skull model.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur Boz, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394881
- Sponsor's protocol ID
- 24/159
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Boz U, Tuzuner AM. Do video animations and 3-D skull models reduce preoperative anxiety in bimaxillary orthognathic surgery patients? Randomized controlled trial. BMC Oral Health. 2026 Jul 22;26(1):2081. doi: 10.1186/s12903-026-09373-5.
PubMed 42919324
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Video Animations and 3-D Skull Models Reduce Preoperative Anxiety in Bimaxillary Orthognathic Surgery Patients? Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07394881
- Acronym / sponsor ID
- 24/159
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 6 Feb 2026 (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.
This study evaluates whether adding visual tools to standard preoperative counseling can reduce anxiety in patients scheduled for bimaxillary orthognathic surgery. Participants aged 18-36 years undergoing elective surgery was randomly assigned to one of three groups: (1) standard verbal information, (2) standard verbal information with a short animation video, (3) standard verbal information with a 3-D anatomical skull model demonstration. Anxiety was assessed using the State-Trait Anxiety Inventory and a visual analog scale at two time points: before the information session and approximately one hour before surgery. The goal is to determine whether visual tools provide additional benefit beyond standard counseling in reducing preoperative anxiety.
Detailed description
This was a single-center, randomized, parallel-group study assessing the effect of different counseling tools on preoperative anxiety in patients undergoing elective bimaxillary orthognathic surgery. All participants received standardized verbal preoperative information delivered in a consistent setting. Group A received verbal information only; Group B received verbal information supplemented with an animation video; and Group C received verbal information supplemented with a 3-D anatomical skull model demonstration. Information sessions were standardized and lasted approximately 10 minutes. Anxiety was measured using the STAI (state and trait components) and a VAS at two predefined time points: baseline (before the information session) and approximately one hour before surgery. The main comparisons were changes in anxiety scores between groups to evaluate whether visual tools reduced preoperative anxiety beyond standard counseling. Data collection of anxiety assessments was performed by blinded personnel, and ethical approval and written informed consent were obtained.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group randomized study comparing standard counseling alone versus counseling supplemented with a video animation or a 3-D skull model.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Verbal İnformationStandardized verbal preoperative information. |
| Video Animation Tools | Experimental | Behavioral: Animation Video Counselinganimation video used as a visual tool during counseling. |
| 3D-Head Skull Tools | Experimental | Behavioral: 3-D Skull Model CounselingAnatomical skull model demonstration used as a visual tool during counseling. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults (≥18 years).
- Scheduled to undergo elective bimaxillary orthognathic surgery under general anesthesia.
- Able to understand the study procedures and complete the anxiety questionnaires.
- Provided written informed consent.
Key exclusion criteria (5 listed)
- Current diagnosis of a major psychiatric disorder or use of anxiolytic/antidepressant medication that could affect anxiety assessment.
- Cognitive impairment or inability to complete the questionnaires.
- Emergency surgery.
- Refusal to participate or withdrawal of consent.
- Any condition judged by the investigator to interfere with participation or outcome assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal İnformationStandardized preoperative verbal information provided to all participants. | Behavioural | Control |
| Animation Video CounselingStandardized preoperative verbal counseling supplemented with an animation video explaining the surgical procedure and potential complications. | Behavioural | Video Animation Tools |
| 3-D Skull Model CounselingStandardized preoperative verbal counseling supplemented with a 3-D anatomical skull model demonstration to explain surgical anatomy and the planned procedure. | Behavioural | 3D-Head Skull Tools |
Primary outcome
Visual Analogue Scale for Anxiety (VAS-A)
Time frame: From baseline (before preoperative counseling) to immediately before surgery
Change in preoperative anxiety level measured using the Visual Analogue Scale for Anxiety (VAS-A). The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).
State-Trait Anxiety Inventory
Time frame: From baseline (before preoperative counseling) to immediately before surgery
Change in state anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The overall (total) score for STAI ranges from a minimum of 20 to a maximum of 80; STAI scores are commonly classified as 'no or low anxiety' (20-37), 'moderate anxiety' (38-44), and 'high anxiety' (45-80)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Derived from this study: PubMed 42919324Boz U, Tuzuner AM. Do video animations and 3-D skull models reduce preoperative anxiety in bimaxillary orthognathic surgery patients? Randomized controlled trial. BMC Oral Health. 2026 Jul 22;26(1):2081. doi: 10.1186/s12903-026-09373-5.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal İnformation, Animation Video Counseling and 3-D Skull Model Counseling in people with Preoperative Anxiety and Orthognathic Surgical Procedures, run by Ankara 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Anxiety (VAS-A) (time frame: From baseline (before preoperative counseling) to immediately before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394881, which also lists 1 linked publication.
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 10 Feb 2026.