Anxiety PostoperativeNCT05948748
Level of Anxiety in Patients Undergoing Invasive Foot Surgery
An observational study of Anxiety Postoperative and Surgery, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
In recent decades, preoperative anxiety has been studied by numerous authors from different medical-surgical specialties, however, there are no studies in the scientific literature on anxiety prior to surgical procedures in the area of minimally invasive foot surgery at the osteoarticular level. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Postoperative, Surgery
- What is being tested?
- foot surgery
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2023to 1 Jan 2024
- How long will I take part?
- 3 Months
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing minimally invasive osteoarticular foot surgery
Who may be able to join
- be over18 years old.
- ASA I and II (American Society of Anesthesiologists).
- autonomous capacity to fill out the surveys and participate in the study
Who cannot join
- mental and/or emotional disorders.
- incapacity to understand.
- people medicated with anxiolytics before the surgery.
- chronic pain in the foot and/or analgesic treatment for chronic pain.
- did not fulfill the postoperative recommendations.
- contraindication to the study's medical guideline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery
In recent decades, preoperative anxiety has been studied by numerous authors from different medical-surgical specialties, however, there are no studies in the scientific literature on anxiety prior to surgical procedures in the area of minimally invasive foot surgery at the osteoarticular level.
The aim of the present study was to determine the level of preoperative anxiety and information using the Amsterdam Preoperative Anxiety and Information scale in patients undergoing minimally invasive podiatric surgery, as well as to determine the socio-demographic and surgical factors associated with preoperative anxiety.
- Conditions
- Anxiety Postoperative, Surgery
- Being tested
- foot surgery
- Keywords
- anxiety, surgery, minor surgical procedures, postoperative pain
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot surgeryProcedure or surgery
minimally invasive osteoarticular foot surgery
| Study group | Role | What they receive |
|---|---|---|
| Anxiety levels | pre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery Receives: Procedure: foot surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-surgical anxiety levels
Amsterdam Pre-Operative Anxiety and Information Scale (APAIS) using a 5-point Likert scale, where 1 = not at all and 5 = total.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start10 Jul 2023
- Primary completion10 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety PostoperativeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 104 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948748
- Sponsor's protocol ID
- 08/07/2023
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laufenberg-Feldmann R, Kappis B, Schuster M, Ferner M. [Relevance of preoperative anxiety for postoperative outcome in urological surgery patients: A prospective observational study]. Schmerz. 2016 Apr;30(2):166-73. doi: 10.1007/s00482-015-0023-3. German.
PubMed 26242358Guo 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 21943828Navarro-Garcia MA, Marin-Fernandez B, de Carlos-Alegre V, Martinez-Oroz A, Martorell-Gurucharri A, Ordonez-Ortigosa E, Prieto-Guembe P, Sorbet-Amostegui MR, Indurain-Fernandez S, Elizondo-Sotro A, Irigoyen-Aristorena MI, Garcia-Aizpun Y. [Preoperative mood disorders in patients undergoing cardiac surgery: risk factors and postoperative morbidity in the intensive care unit]. Rev Esp Cardiol. 2011 Nov;64(11):1005-10. doi: 10.1016/j.recesp.2011.06.009. Epub 2011 Sep 15. Spanish.
PubMed 21924811Navarro-Gaston D, Munuera-Martinez PV. Prevalence of Preoperative Anxiety and Its Relationship with Postoperative Pain in Foot Nail Surgery: A Cross-Sectional Study. Int J Environ Res Public Health. 2020 Jun 22;17(12):4481. doi: 10.3390/ijerph17124481.
PubMed 32580413Zelenikova R, Homzova P, Homza M, Buzgova R. Validity and Reliability of the Czech Version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). J Perianesth Nurs. 2017 Oct;32(5):429-437. doi: 10.1016/j.jopan.2016.03.007. Epub 2016 Dec 28.
PubMed 28938978Wu H, Zhao X, Chu S, Xu F, Song J, Ma Z, Gu X. Validation of the Chinese version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Health Qual Life Outcomes. 2020 Mar 11;18(1):66. doi: 10.1186/s12955-020-01294-3.
PubMed 32160883Aust H, Eberhart L, Sturm T, Schuster M, Nestoriuc Y, Brehm F, Rusch D. A cross-sectional study on preoperative anxiety in adults. J Psychosom Res. 2018 Aug;111:133-139. doi: 10.1016/j.jpsychores.2018.05.012. Epub 2018 May 22.
PubMed 29935747Vergara-Romero M, Morales-Asencio JM, Morales-Fernandez A, Canca-Sanchez JC, Rivas-Ruiz F, Reinaldo-Lapuerta JA. Validation of the Spanish version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Health Qual Life Outcomes. 2017 Jun 7;15(1):120. doi: 10.1186/s12955-017-0695-8.
PubMed 28592310
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery
- ClinicalTrials.gov ID
- NCT05948748
- Acronym / sponsor ID
- 08/07/2023
- Conditions
- Anxiety Postoperative, Surgery
- Keywords
- anxiety, surgery, minor surgical procedures, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Jul 2023 (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.
In recent decades, preoperative anxiety has been studied by numerous authors from different medical-surgical specialties, however, there are no studies in the scientific literature on anxiety prior to surgical procedures in the area of minimally invasive foot surgery at the osteoarticular level.
The aim of the present study was to determine the level of preoperative anxiety and information using the Amsterdam Preoperative Anxiety and Information scale in patients undergoing minimally invasive podiatric surgery, as well as to determine the socio-demographic and surgical factors associated with preoperative anxiety.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxiety levels | – | Procedure: foot surgerypre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing minimally invasive osteoarticular foot surgery
Key inclusion criteria (3 listed)
- be over18 years old.
- ASA I and II (American Society of Anesthesiologists).
- autonomous capacity to fill out the surveys and participate in the study
Key exclusion criteria (6 listed)
- mental and/or emotional disorders.
- incapacity to understand.
- people medicated with anxiolytics before the surgery.
- chronic pain in the foot and/or analgesic treatment for chronic pain.
- did not fulfill the postoperative recommendations.
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 |
|---|---|---|
| foot surgeryminimally invasive osteoarticular foot surgery | Procedure or surgery | Anxiety levels |
Primary outcome
pre-surgical anxiety levels
Time frame: 1 day
Amsterdam Pre-Operative Anxiety and Information Scale (APAIS) using a 5-point Likert scale, where 1 = not at all and 5 = total.
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 18 Jul 2024.
- Background: PubMed 26242358Laufenberg-Feldmann R, Kappis B, Schuster M, Ferner M. [Relevance of preoperative anxiety for postoperative outcome in urological surgery patients: A prospective observational study]. Schmerz. 2016 Apr;30(2):166-73. doi: 10.1007/s00482-015-0023-3. German.
- 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 21924811Navarro-Garcia MA, Marin-Fernandez B, de Carlos-Alegre V, Martinez-Oroz A, Martorell-Gurucharri A, Ordonez-Ortigosa E, Prieto-Guembe P, Sorbet-Amostegui MR, Indurain-Fernandez S, Elizondo-Sotro A, Irigoyen-Aristorena MI, Garcia-Aizpun Y. [Preoperative mood disorders in patients undergoing cardiac surgery: risk factors and postoperative morbidity in the intensive care unit]. Rev Esp Cardiol. 2011 Nov;64(11):1005-10. doi: 10.1016/j.recesp.2011.06.009. Epub 2011 Sep 15. Spanish.
- Results publication: PubMed 32580413Navarro-Gaston D, Munuera-Martinez PV. Prevalence of Preoperative Anxiety and Its Relationship with Postoperative Pain in Foot Nail Surgery: A Cross-Sectional Study. Int J Environ Res Public Health. 2020 Jun 22;17(12):4481. doi: 10.3390/ijerph17124481.
- Results publication: PubMed 28938978Zelenikova R, Homzova P, Homza M, Buzgova R. Validity and Reliability of the Czech Version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). J Perianesth Nurs. 2017 Oct;32(5):429-437. doi: 10.1016/j.jopan.2016.03.007. Epub 2016 Dec 28.
- Results publication: PubMed 32160883Wu H, Zhao X, Chu S, Xu F, Song J, Ma Z, Gu X. Validation of the Chinese version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Health Qual Life Outcomes. 2020 Mar 11;18(1):66. doi: 10.1186/s12955-020-01294-3.
- Results publication: PubMed 29935747Aust H, Eberhart L, Sturm T, Schuster M, Nestoriuc Y, Brehm F, Rusch D. A cross-sectional study on preoperative anxiety in adults. J Psychosom Res. 2018 Aug;111:133-139. doi: 10.1016/j.jpsychores.2018.05.012. Epub 2018 May 22.
- Results publication: PubMed 28592310Vergara-Romero M, Morales-Asencio JM, Morales-Fernandez A, Canca-Sanchez JC, Rivas-Ruiz F, Reinaldo-Lapuerta JA. Validation of the Spanish version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Health Qual Life Outcomes. 2017 Jun 7;15(1):120. doi: 10.1186/s12955-017-0695-8.
- 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.
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?
An observational study of Anxiety Postoperative and Surgery, run by Universidad Católica de Ávila at 1 site in Spain.
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 6 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 18 Jul 2024. 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 Spain. 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?
pre-surgical anxiety levels (time frame: 1 day). 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 NCT05948748, which also lists 8 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 18 Jul 2024.