AnxietyiPAEonAnxNCT07032012
Impact of Pre-anesthetic Evaluation on the Anxiety
A study testing group intervention - anxiety evaluation after Pre-anesthetic in people with Anxiety and Postoperative Care, run by Hospital de Base.
Trial summary
Since the last century, it has been understood that "the pre-anesthetic evaluation is the patient's right and the anesthesiologist's duty." As early as 2006, the Conselho Federal de Medicina (CFM) published a resolution addressing the anesthetic act and guiding the conduct of pre-anesthetic evaluation (PAE) and in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Postoperative Care, Preoperative Anxiety
- What is being tested?
- group intervention - anxiety evaluation after Pre-anesthetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- elective or urgent orthopedic surgery
- aged between 18 and 65 years
- ASA classification I to III
Who cannot join
- Patient refusal to participate
- Patient refusal to sign the IC
- Lack of education
- History of psychiatric illness, especially depression
- Limited cognitive capacity (self-declared or informed by a companion)
- Prolonged hospitalization (greater than or equal to 14 days)
- Emergency surgery
- Inability to understand the IC.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Pre-anesthetic Evaluation on the Anxiety of Orthopedic Patients: a Randomized Clinical Trial.
Since the last century, it has been understood that "the pre-anesthetic evaluation is the patient's right and the anesthesiologist's duty." As early as 2006, the Conselho Federal de Medicina (CFM) published a resolution addressing the anesthetic act and guiding the conduct of pre-anesthetic evaluation (PAE) and in 2017 revised these guidelines in a new resolution. The PAE is an important step in preparing the patient for elective surgical procedures. It refers to the moment when the anesthesiologist and patient have the opportunity to get to know each other, optimize the patient's clinical conditions and even request exams or consult other specialists when necessary. The prevalence and levels of anxiety, commonly generated by the expectation of the surgical-anesthetic procedure, tend to reduce with the PAE. This leads to fewer patients presenting to the operating room with arterial hypertension or arrhythmia, which are triggered by anxiety. It can be said that the implementation of the PAE directs screening processes and consequently reduces the patient's risk to unnecessary procedures or consultations. It also highlights the reduction in perioperative morbidity and mortality rates. By analyzing the dynamics of the surgical center, where the space is highly technological and contested by various surgical specialties, it is possible to associate the PAE with the reduction in cancellation rates of procedures and the proper use of space. Measuring sentiment is difficult and to assess anxiety, one can use complex questionnaires to small and objective scales. Some studies show how anxiety can contribute to increased postoperative pain, higher medication consumption, and longer hospitalization time. A possible tool to change this scenario would be the PAE, but its relationship with anxiety still needs to be further documented, especially in Brazil. Therefore, this project seeks to study the hypothesis that the PAE reduces anxiety levels, brings quality to the anesthetic-surgical experience, and improves perioperative morbidity indicators. This study aims to evaluate the impact of pre-anesthetic evaluation on perioperative surgical outcomes in patients of the orthopedic specialty undergoing procedures at the institution. It aims to identify the anxiety level of patients undergoing orthopedic surgery. This randomized clinical trial will be conducted at the Hospital de Base do Distrito Federal, Brasília, Distrito Federal, Brazil.
- Conditions
- Anxiety, Postoperative Care, Preoperative Anxiety
- Being tested
- control - anxiety evaluation before Pre-anesthetic, group intervention - anxiety evaluation after Pre-anesthetic
- Keywords
- Anesthesia, Orthopedics, Anxiety, Postoperative
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control - anxiety evaluation before Pre-anestheticOther
If allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted.
group intervention - anxiety evaluation after Pre-anestheticOther
If allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied.
| Study group | Role | What they receive |
|---|---|---|
| control - anxiety evaluation before Pre-anesthetic | Other | If allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted. Receives: Other: control - anxiety evaluation before Pre-anesthetic; Other: group intervention - anxiety evaluation after Pre-anesthetic |
| intervention - anxiety evaluation after Pre-anesthetic | Active comparator | If allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied. Receives: Other: control - anxiety evaluation before Pre-anesthetic; Other: group intervention - anxiety evaluation after Pre-anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre operative anxiety levels
Assessment of pre operative anxiety levels using the State-Trait Anxiety Inventory - anxiety scale in patients who will or will not receive pre-anesthesia assessment in orthopedic surgeries. The score on this scale ranges from 10 to 40, with 10 being the calmest possible individual and 40 being the most anxious possible.
Measured: Before the procedure.
Secondary outcomes (1)
Assess anxiety levels using the Likert scale
Assess anxiety levels using the Likert scale. This scale has a drawing of 5 faces that range from very anxious (on the left) to very calm (on the right)
Measured: Before the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032012
- Sponsor's protocol ID
- iPAEonAnx
- Acronym
- iPAEonAnx
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ambulkar R, Patel A, Patil S, Savarkar S. Patient satisfaction with anaesthesia services in a tertiary care cancer centre. (SAY study). J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):111-117. doi: 10.4103/joacp.JOACP_187_20. Epub 2022 Jan 12.
PubMed 35706652
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-anesthetic Evaluation on the Anxiety of Orthopedic Patients: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07032012
- Acronym / sponsor ID
- iPAEonAnx / iPAEonAnx
- Conditions
- Anxiety, Postoperative Care, Preoperative Anxiety
- Keywords
- Anesthesia, Orthopedics, Anxiety, Postoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Jun 2025 (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.
Since the last century, it has been understood that "the pre-anesthetic evaluation is the patient's right and the anesthesiologist's duty." As early as 2006, the Conselho Federal de Medicina (CFM) published a resolution addressing the anesthetic act and guiding the conduct of pre-anesthetic evaluation (PAE) and in 2017 revised these guidelines in a new resolution. The PAE is an important step in preparing the patient for elective surgical procedures. It refers to the moment when the anesthesiologist and patient have the opportunity to get to know each other, optimize the patient's clinical conditions and even request exams or consult other specialists when necessary. The prevalence and levels of anxiety, commonly generated by the expectation of the surgical-anesthetic procedure, tend to reduce with the PAE. This leads to fewer patients presenting to the operating room with arterial hypertension or arrhythmia, which are triggered by anxiety. It can be said that the implementation of the PAE directs screening processes and consequently reduces the patient's risk to unnecessary procedures or consultations. It also highlights the reduction in perioperative morbidity and mortality rates. By analyzing the dynamics of the surgical center, where the space is highly technological and contested by various surgical specialties, it is possible to associate the PAE with the reduction in cancellation rates of procedures and the proper use of space. Measuring sentiment is difficult and to assess anxiety, one can use complex questionnaires to small and objective scales. Some studies show how anxiety can contribute to increased postoperative pain, higher medication consumption, and longer hospitalization time. A possible tool to change this scenario would be the PAE, but its relationship with anxiety still needs to be further documented, especially in Brazil. Therefore, this project seeks to study the hypothesis that the PAE reduces anxiety levels, brings quality to the anesthetic-surgical experience, and improves perioperative morbidity indicators. This study aims to evaluate the impact of pre-anesthetic evaluation on perioperative surgical outcomes in patients of the orthopedic specialty undergoing procedures at the institution. It aims to identify the anxiety level of patients undergoing orthopedic surgery. This randomized clinical trial will be conducted at the Hospital de Base do Distrito Federal, Brasília, Distrito Federal, Brazil.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control - anxiety evaluation before Pre-anesthetic | Other | Other: control - anxiety evaluation before Pre-anesthetic, Other: group intervention - anxiety evaluation after Pre-anestheticIf allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted. |
| intervention - anxiety evaluation after Pre-anesthetic | Active comparator | Other: control - anxiety evaluation before Pre-anesthetic, Other: group intervention - anxiety evaluation after Pre-anestheticIf allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective or urgent orthopedic surgery
- aged between 18 and 65 years
- ASA classification I to III
Key exclusion criteria (8 listed)
- Patient refusal to participate
- Patient refusal to sign the IC
- Lack of education
- History of psychiatric illness, especially depression
- Limited cognitive capacity (self-declared or informed by a companion)
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 |
|---|---|---|
| control - anxiety evaluation before Pre-anestheticIf allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted. | Other | control - anxiety evaluation before Pre-anesthetic, intervention - anxiety evaluation after Pre-anesthetic |
| group intervention - anxiety evaluation after Pre-anestheticIf allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied. | Other | control - anxiety evaluation before Pre-anesthetic, intervention - anxiety evaluation after Pre-anesthetic |
Primary outcome
Pre operative anxiety levels
Time frame: Before the procedure.
Assessment of pre operative anxiety levels using the State-Trait Anxiety Inventory - anxiety scale in patients who will or will not receive pre-anesthesia assessment in orthopedic surgeries. The score on this scale ranges from 10 to 40, with 10 being the calmest possible individual and 40 being the most anxious possible.
1 secondary outcome
Assess anxiety levels using the Likert scale
Time frame: Before the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 35706652Ambulkar R, Patel A, Patil S, Savarkar S. Patient satisfaction with anaesthesia services in a tertiary care cancer centre. (SAY study). J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):111-117. doi: 10.4103/joacp.JOACP_187_20. Epub 2022 Jan 12.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing group intervention - anxiety evaluation after Pre-anesthetic in people with Anxiety and Postoperative Care, run by Hospital de Base.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iuri Ferreira Lopes Iuri Ferreira Lopes, MD (+55 (61) 99620-6361, iuri_fl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre operative anxiety levels (time frame: Before the procedure.). 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 NCT07032012, 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 22 Jun 2025.