Preoperative AnxietyAI-COMNCT07393945
Structured Communication About Artificial Intelligence in Perioperative Care (AI-COM)
A study testing Structured Artificial Intelligence Communication in people with Preoperative Anxiety and Perceived Control, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether structured communication about artificial intelligence (AI) in perioperative care can reduce preoperative anxiety and improve perceived control among adult patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preoperative Anxiety, Perceived Control, AI-Related Uncertainty
- What is being tested?
- Structured Artificial Intelligence Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2026to 25 Apr 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Scheduled for elective surgical procedures.
- Able to communicate in Turkish.
- At least primary school literacy.
- Able and willing to provide written informed consent.
- Able to complete self-report questionnaires before surgery.
Who cannot join
- Emergency surgical procedures.
- Known diagnosis of psychiatric disorder.
- Current use of anxiolytic or antidepressant medications.
- Cognitive impairment or communication barriers that may interfere with study participation.
- American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
- Severe visual or hearing impairment that prevents participation in the communication session or completion of questionnaires.
- Previous participation in this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Training and Research Hospital
Ağrı, Merkez
About this study
Official title: Effects of Structured Communication About Artificial Intelligence in Perioperative Care on Preoperative Anxiety and Perceived Control: An Attention-Controlled Randomized Trial
This study investigates whether structured communication about artificial intelligence (AI) in perioperative care can reduce preoperative anxiety and improve perceived control among adult patients undergoing elective surgery.
As AI-supported tools become more common in healthcare, patients may feel uncertain about how these technologies relate to their care, whether they influence clinical decisions, and whether healthcare professionals remain responsible for final decision-making. Such uncertainty may contribute to anxiety before surgery and may reduce patients' sense of control.
Read more
In this attention-controlled randomized trial, adult patients scheduled for elective surgery will be assigned to one of two groups. The attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. The intervention group will receive standard preoperative information plus a structured, non-technical communication protocol about AI in perioperative care. The protocol will explain the supportive role of AI, emphasize human clinical oversight, address AI-related uncertainty, and help patients understand that general information about AI must be interpreted in relation to their individual clinical situation.
Preoperative anxiety, perceived control, AI-related uncertainty, information clarity, and trust in the clinical team will be assessed using structured questionnaires. The study does not test or evaluate any AI software, medical device, imaging system, or diagnostic technology. Instead, it focuses on whether structured communication about AI-related uncertainty can improve psychological preparedness before surgery.
The findings may help inform practical, transparent, and patient-centered communication strategies for discussing AI-supported healthcare technologies in perioperative settings.
Read the detailed description
Artificial intelligence (AI)-supported tools are increasingly discussed and implemented across healthcare, including perioperative care. Although the technical performance and clinical applications of AI systems have been widely studied, less attention has been given to how patients understand and psychologically respond to information about AI-supported healthcare technologies. Patients may be uncertain about the role of AI, whether it replaces or supports clinical judgment, how human oversight is maintained, and how general information about AI applies to their own care.
Preoperative anxiety is common among surgical patients and may be influenced by uncertainty, limited understanding of care processes, and difficulty interpreting health-related information. Perceived control may help patients cope with uncertainty by improving their ability to understand what is happening, how care decisions are guided, and how general information relates to their individual clinical context. Structured communication may therefore be a feasible strategy to reduce AI-related uncertainty, improve perceived control, and support psychological preparedness before surgery.
This single-center, two-arm, attention-controlled randomized trial will evaluate the effects of structured communication about AI in perioperative care on preoperative anxiety and perceived control among adult patients scheduled for elective surgery. A total of 120 participants will be randomized in a 1:1 ratio to either an attention-control group or an intervention group.
Participants in the attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. This session will be similar in duration to the intervention session and will focus on general preoperative support and routine patient questions. It will not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.
Participants in the intervention group will receive standard preoperative information plus a structured AI communication protocol delivered face-to-face by a trained nurse. The protocol will use clear, non-technical, patient-centered language and will explain the supportive role of AI in healthcare, emphasize that clinical decisions remain under professional human oversight, address uncertainty related to AI-supported technologies, contextualize general AI-related information for the individual patient, and encourage patient questions.
The intervention does not involve the use, testing, or evaluation of any AI software, medical device, imaging system, or diagnostic technology. The study does not assess the diagnostic accuracy, technical performance, or clinical effectiveness of AI-supported systems. Instead, it evaluates the psychological and communication-related effects of structured explanation about AI in perioperative care.
Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale. Perceived control, AI-related uncertainty, information clarity, trust in the clinical team, and baseline eHealth literacy will also be assessed using structured questionnaires. Outcomes will be measured at baseline before randomization and after the communication session before surgery. Statistical analyses will compare post-communication outcomes between groups while accounting for baseline values where applicable.
This study aims to inform patient-centered and ethically responsible communication strategies for discussing AI-supported technologies in perioperative care.
- Being tested
- Structured Artificial Intelligence Communication, Attention-Control Supportive Communication
- Keywords
- Perioperative care, Patient communication, Perceived control, Artificial intelligence, eHealth literacy, Structured communication, Attention-controlled randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Artificial Intelligence CommunicationBehavioural
A brief, approximately 5-7-minute, face-to-face structured communication protocol delivered by a trained nurse using clear, non-technical, patient-centered language. The protocol explains the supportive role of artificial intelligence in perioperative care, emphasizes that clinical decisions remain under professional human oversight, addresses AI-related uncertainty, contextualizes general AI-related information for the individual patient, and encourages patient questions. No AI software, medical device, imaging system, or diagnostic technology is used, tested, or evaluated as part of this intervention.
Attention-Control Supportive CommunicationOther
A brief, approximately 5-7-minute, face-to-face general supportive nurse-patient communication session delivered in addition to standard preoperative information. The session is time-matched to the structured AI communication protocol and focuses on general preoperative support and routine patient questions. It does not include structured explanation of artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.
| Study group | Role | What they receive |
|---|---|---|
| Structured AI Communication | Experimental | Participants in this arm will receive standard preoperative information plus a structured, non-technical communication protocol about artificial intelligence in perioperative care. The protocol is delivered face-to-face by a trained nurse and is designed to reduce AI-related uncertainty, improve information clarity, emphasize professional human oversight of AI-supported systems, and help patients understand how general information about AI relates to their individual clinical situation. Receives: Behavioral: Structured Artificial Intelligence Communication |
| Attention-Control Supportive Communication | Active comparator | Participants in this arm will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. The session is similar in duration to the structured AI communication protocol and focuses on general preoperative support and routine patient questions. It does not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support. Receives: Other: Attention-Control Supportive Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Communication Preoperative Anxiety
Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscale. The primary outcome is the post-communication APAIS anxiety score measured before surgery, with baseline APAIS anxiety accounted for in the analysis. The APAIS anxiety subscale consists of 4 items scored on a 5-point Likert scale, with total scores ranging from 4 to 20. Higher scores indicate higher preoperative anxiety.
Measured: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.
Secondary outcomes (1)
Post-Communication Perceived Control
Post-communication perceived control will be assessed using an adapted 8-item perceived control measure for the healthcare context. Each item is rated on a 5-point Likert scale, with total scores ranging from 8 to 40. Higher scores indicate greater perceived control, defined as the patient's perceived ability to understand the care process, interpret relevant information, and feel oriented within the perioperative care context. The outcome is the post-communication perceived control score measured before surgery, with baseline perceived control accounted for in the analysis.
Measured: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.
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 start5 Feb 2026
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups. The intervention group will receive standard preoperative information plus a structured communication protocol about artificial intelligence in perioperative care. The attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session that does not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Gokmen, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393945
- Sponsor's protocol ID
- AI-XAI-PA-2026
- Acronym
- AI-COM
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive psychological outcome data and a relatively small single-center sample, which may increase the risk of participant re-identification. De-identified aggregate results will be reported in publications and trial results summaries.
Publications
Chan SL, Sit JWH, Ang WW, Lau Y. Virtual reality-enhanced interventions on preoperative anxiety symptoms in adults undergoing elective surgery: A meta-analysis and meta-regression. Int J Nurs Stud. 2024 Dec;160:104886. doi: 10.1016/j.ijnurstu.2024.104886. Epub 2024 Aug 30.
PubMed 39270596Xu H, Hou J, Zhou J, Wang S. Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis. J Perianesth Nurs. 2025 Apr;40(2):422-430.e3. doi: 10.1016/j.jopan.2024.05.009. Epub 2024 Sep 26.
PubMed 39340515Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22.
PubMed 21943828Yahagi M, Hiruta R, Miyauchi C, Tanaka S, Taguchi A, Yaguchi Y. Comparison of Conventional Anesthesia Nurse Education and an Artificial Intelligence Chatbot (ChatGPT) Intervention on Preoperative Anxiety: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Oct;39(5):767-771. doi: 10.1016/j.jopan.2023.12.005. Epub 2024 Mar 21.
PubMed 38520470
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Structured Communication About Artificial Intelligence in Perioperative Care on Preoperative Anxiety and Perceived Control: An Attention-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT07393945
- Acronym / sponsor ID
- AI-COM / AI-XAI-PA-2026
- Keywords
- Perioperative care, Patient communication, Perceived control, Artificial intelligence, eHealth literacy, Structured communication, Attention-controlled randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (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 investigates whether structured communication about artificial intelligence (AI) in perioperative care can reduce preoperative anxiety and improve perceived control among adult patients undergoing elective surgery.
As AI-supported tools become more common in healthcare, patients may feel uncertain about how these technologies relate to their care, whether they influence clinical decisions, and whether healthcare professionals remain responsible for final decision-making. Such uncertainty may contribute to anxiety before surgery and may reduce patients' sense of control.
In this attention-controlled randomized trial, adult patients scheduled for elective surgery will be assigned to one of two groups. The attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. The intervention group will receive standard preoperative information plus a structured, non-technical communication protocol about AI in perioperative care. The protocol will explain the supportive role of AI, emphasize human clinical oversight, address AI-related uncertainty, and help patients understand that general information about AI must be interpreted in relation to their individual clinical situation.
Preoperative anxiety, perceived control, AI-related uncertainty, information clarity, and trust in the clinical team will be assessed using structured questionnaires. The study does not test or evaluate any AI software, medical device, imaging system, or diagnostic technology. Instead, it focuses on whether structured communication about AI-related uncertainty can improve psychological preparedness before surgery.
The findings may help inform practical, transparent, and patient-centered communication strategies for discussing AI-supported healthcare technologies in perioperative settings.
Detailed description
Artificial intelligence (AI)-supported tools are increasingly discussed and implemented across healthcare, including perioperative care. Although the technical performance and clinical applications of AI systems have been widely studied, less attention has been given to how patients understand and psychologically respond to information about AI-supported healthcare technologies. Patients may be uncertain about the role of AI, whether it replaces or supports clinical judgment, how human oversight is maintained, and how general information about AI applies to their own care.
Preoperative anxiety is common among surgical patients and may be influenced by uncertainty, limited understanding of care processes, and difficulty interpreting health-related information. Perceived control may help patients cope with uncertainty by improving their ability to understand what is happening, how care decisions are guided, and how general information relates to their individual clinical context. Structured communication may therefore be a feasible strategy to reduce AI-related uncertainty, improve perceived control, and support psychological preparedness before surgery.
This single-center, two-arm, attention-controlled randomized trial will evaluate the effects of structured communication about AI in perioperative care on preoperative anxiety and perceived control among adult patients scheduled for elective surgery. A total of 120 participants will be randomized in a 1:1 ratio to either an attention-control group or an intervention group.
Participants in the attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. This session will be similar in duration to the intervention session and will focus on general preoperative support and routine patient questions. It will not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.
Participants in the intervention group will receive standard preoperative information plus a structured AI communication protocol delivered face-to-face by a trained nurse. The protocol will use clear, non-technical, patient-centered language and will explain the supportive role of AI in healthcare, emphasize that clinical decisions remain under professional human oversight, address uncertainty related to AI-supported technologies, contextualize general AI-related information for the individual patient, and encourage patient questions.
The intervention does not involve the use, testing, or evaluation of any AI software, medical device, imaging system, or diagnostic technology. The study does not assess the diagnostic accuracy, technical performance, or clinical effectiveness of AI-supported systems. Instead, it evaluates the psychological and communication-related effects of structured explanation about AI in perioperative care.
Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale. Perceived control, AI-related uncertainty, information clarity, trust in the clinical team, and baseline eHealth literacy will also be assessed using structured questionnaires. Outcomes will be measured at baseline before randomization and after the communication session before surgery. Statistical analyses will compare post-communication outcomes between groups while accounting for baseline values where applicable.
This study aims to inform patient-centered and ethically responsible communication strategies for discussing AI-supported technologies in perioperative care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups. The intervention group will receive standard preoperative information plus a structured communication protocol about artificial intelligence in perioperative care. The attention-control group will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session that does not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support.
| Arm | Type | Receives |
|---|---|---|
| Structured AI Communication | Experimental | Behavioral: Structured Artificial Intelligence CommunicationParticipants in this arm will receive standard preoperative information plus a structured, non-technical communication protocol about artificial intelligence in perioperative care. The protocol is delivered face-to-face by a trained nurse and is designed to reduce AI-related uncertainty, improve information clarity, emphasize professional human oversight of AI-supported systems, and help patients understand how general information about AI relates to their individual clinical situation. |
| Attention-Control Supportive Communication | Active comparator | Other: Attention-Control Supportive CommunicationParticipants in this arm will receive standard preoperative information plus a time-matched general supportive nurse-patient communication session. The session is similar in duration to the structured AI communication protocol and focuses on general preoperative support and routine patient questions. It does not include structured content about artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 65 years.
- Scheduled for elective surgical procedures.
- Able to communicate in Turkish.
- At least primary school literacy.
- Able and willing to provide written informed consent.
Key exclusion criteria (7 listed)
- Emergency surgical procedures.
- Known diagnosis of psychiatric disorder.
- Current use of anxiolytic or antidepressant medications.
- Cognitive impairment or communication barriers that may interfere with study participation.
- American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
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 |
|---|---|---|
| Structured Artificial Intelligence CommunicationA brief, approximately 5-7-minute, face-to-face structured communication protocol delivered by a trained nurse using clear, non-technical, patient-centered language. The protocol explains the supportive role of artificial intelligence in perioperative care, emphasizes that clinical decisions remain under professional human oversight, addresses AI-related uncertainty, contextualizes general AI-related information for the individual patient, and encourages patient questions. No AI software, medical device, imaging system, or diagnostic technology is used, tested, or evaluated as part of this intervention. | Behavioural | Structured AI Communication |
| Attention-Control Supportive CommunicationA brief, approximately 5-7-minute, face-to-face general supportive nurse-patient communication session delivered in addition to standard preoperative information. The session is time-matched to the structured AI communication protocol and focuses on general preoperative support and routine patient questions. It does not include structured explanation of artificial intelligence, AI-related uncertainty, human oversight of AI-supported systems, or technology-related decision support. | Other | Attention-Control Supportive Communication |
Primary outcome
Post-Communication Preoperative Anxiety
Time frame: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.
Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscale. The primary outcome is the post-communication APAIS anxiety score measured before surgery, with baseline APAIS anxiety accounted for in the analysis. The APAIS anxiety subscale consists of 4 items scored on a 5-point Likert scale, with total scores ranging from 4 to 20. Higher scores indicate higher preoperative anxiety.
1 secondary outcome
Post-Communication Perceived Control
Time frame: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.
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 4 May 2026.
- Background: PubMed 39270596Chan SL, Sit JWH, Ang WW, Lau Y. Virtual reality-enhanced interventions on preoperative anxiety symptoms in adults undergoing elective surgery: A meta-analysis and meta-regression. Int J Nurs Stud. 2024 Dec;160:104886. doi: 10.1016/j.ijnurstu.2024.104886. Epub 2024 Aug 30.
- Background: PubMed 39340515Xu H, Hou J, Zhou J, Wang S. Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis. J Perianesth Nurs. 2025 Apr;40(2):422-430.e3. doi: 10.1016/j.jopan.2024.05.009. Epub 2024 Sep 26.
- Background: PubMed 21943828Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22.
- Background: PubMed 38520470Yahagi M, Hiruta R, Miyauchi C, Tanaka S, Taguchi A, Yaguchi Y. Comparison of Conventional Anesthesia Nurse Education and an Artificial Intelligence Chatbot (ChatGPT) Intervention on Preoperative Anxiety: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Oct;39(5):767-771. doi: 10.1016/j.jopan.2023.12.005. Epub 2024 Mar 21.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes sensitive psychological outcome data and a relatively small single-center sample, which may increase the risk of participant re-identification. De-identified aggregate results will be reported in publications and trial results summaries.
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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 Structured Artificial Intelligence Communication in people with Preoperative Anxiety and Perceived Control, run by Agri Ibrahim Cecen 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 6 inclusion and 7 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 4 May 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?
Post-Communication Preoperative Anxiety (time frame: Baseline before randomization and post-communication before surgery, approximately 10-20 minutes after baseline assessment.). 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 NCT07393945, which also lists 4 linked publications.
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 4 May 2026.