AnxietyNCT06531252
Perioperative Anxiety Among Patients Undergoing Coronary Angiography or Angioplasty
An observational study of Anxiety, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
Anxiety is defined as apprehension, tension, or uneasiness that originates from the danger which may be internal or external. Anxiety may manifest with symptoms related to behavior, emotions, and cognition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- How many people
- 306 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2022to 15 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: On the procedural day, when the patients were in waiting room at DSA unit, investigators distributed a self-administer questionnaire to patients who had accepted to participate
Who may be able to join
- The patients were included in our study when the patients were more than 18 years old and were able to comprehend Vietnamese language.
Who cannot join
- The patients were excluded from our study if the patients were unconscious and not oriented
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Perioperative Anxiety Among Patients Undergoing Coronary Angiography or Angioplasty: a Cross-sectional Study
Anxiety is defined as apprehension, tension, or uneasiness that originates from the danger which may be internal or external. Anxiety may manifest with symptoms related to behavior, emotions, and cognition. Anxiety is prevalent in patients before interventional procedures and deteriorates postoperative outcomes, for example, elevated level of postoperative pain, increased infection rate, and high mortality rate.
Coronary artery disease is one of the leading causes of mortality, disability, and workforce loss, resulting from the narrowing or obstruction of one or more branches of the coronary arteries due to the accumulation of atherosclerotic plaques. Coronary angiogram and angioplasty are among the most popular diagnostic and treatment tools available to cardiologists. However, patients and their families often experience anxiety before the procedure due to inadequate psychological preparation.
The majority of research about perioperative anxiety focused on surgery. Magnitude of preoperative anxiety as reported in some studies was in the range of 60-80% in the western population while some researchers showed a wider range, which was 11-80%. However, there is a lack of research reporting the prevalence of anxiety among patients arranged for minimally invasive procedures, especially coronary procedures. To the best of our knowledge, a cross-sectional study conducted in Africa among 267 cardiac patients found that 70.4% of them experienced perioperative anxiety. In contrast, similar studies reported that this figure was 35.0% in Europe and 35.7% in Australia. There was significant variation of anxiety level across countries. As a result, it is unacceptable to extrapolate the magnitude of anxiety in one nation to another with different socio-demographic characteristics, healthcare systems and family support. Moreover anxiety levels before surgery are influenced by various factors such as individual susceptibility, age, gender, prior surgical experiences, education, type and complexity of the surgery, current health condition, and socioeconomic status. Identifying risk factors helps healthcare provider to support psychological services during the preoperative visit so that stress can be reduced. Thus, the aim of this study was to evaluate the extent of preoperative anxiety among Vietnamese patients and explore the factors associated with it within the context of Asian culture.
Read the detailed description
This is a cross-sectional study conducted at University Medical Center Ho Chi Minh City. The patients were included in our study when patients were more than 18 years old and were able to comprehend Vietnamese language. The patients were excluded from study if the patients were unconscious and not oriented. On the procedural day, when the patients were in waiting room at DSA unit, investigators distributed a self-administer questionnaire to patients who had accepted to participate. The questionnaire is constructed from three parts, namely, demographics, perioperative factors, and the anxiety scale. Investigators employed "The Pre-operative Intrusive Thoughts Inventory (PITI)" as a tool to measure the anxiety scale. PITI 20 comprises twenty questions. This valid and reliable tool has Cronbach's Alpha score of 0.91. The English questionnaire was adapted and translated into the Vietnamese language and back to English. The answers contain 4 response options (4-point Likert scale ranging from "not at all" with 0 points, "some of the time" with 1 point, "often" with 2 points, and "most of the time" with 3 points). 0 and 60 points are the highest and lowest score respectively, the author of the tool reported that patients with 15 or more scores on the PITI-20 scale reliably were classified as high preoperative anxiety while participants who scored less than fifteen were classified as low preoperative anxiety. Section A: Demographic characteristics (8 questions) Section B: perioperative factors (4 questions) Section C: Pre-operative Intrusive Thoughts Inventory (PITI) anxiety scale (20 questions).
Categorical and nominal variables were presented as percentages and continuous variables as means and standard deviations. Noncontinuous variables were compared using the chi-square test and continuous variables using Student's t-test. Independent variables were identified via logistic regression. A two-sided p-value of <0.05 was considered to indicate statistical significance.
- Conditions
- Anxiety
- Keywords
- Anxiety
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with perioperative anxiety as assessed by "The Pre-operative Intrusive Thoughts Inventory (PITI)"
"The Pre-operative Intrusive Thoughts Inventory (PITI)" was employed. PITI 20, comprises twenty questions.The English questionnaire was adapted and translated into the Vietnamese language and back to English. The answers contain 4 response options (4-point Likert scale ranging from "not at all" with 0 points, "some of the time" with 1 point, "often" with 2 points, and "most of the time" with 3 points). 0 and 60 points are the highest and lowest score respectively, the author of the tool reported that patients with 15 or more scores on the PITI-20 scale reliably were classified as high preoperative anxiety while participants who scored less than fifteen were classified as low preoperative anxiety.
Measured: 08/2022 - 07/2024
Identify demographic characteristics and perioperative factors related to perioperative anxiety
Demographic and perioperative factors are age, gender, marital status, occupation, educational status, average monthly income, locality, living situation, previous hospitalization, previous coronary angiography/angioplasty, pre-procedural anesthesia information, indication-to-procedure duration (hours). Logistic regression analysis was employed to indentify which variables were related to perioperative anxiety (according to PITI 20 score) independently.
Measured: 08/2022 - 07/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2022
- Primary completion1 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531252
- Sponsor's protocol ID
- 83/GCN-HĐĐĐ
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araujo-Soares V. Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study. J Pain. 2012 Nov;13(11):1045-57. doi: 10.1016/j.jpain.2012.07.014. Epub 2012 Oct 12.
PubMed 23063345Starkweather AR, Witek-Janusek L, Nockels RP, Peterson J, Mathews HL. Immune function, pain, and psychological stress in patients undergoing spinal surgery. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E641-7. doi: 10.1097/01.brs.0000231795.85409.87.
PubMed 16915080Takagi H, Ando T, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels. 2017 Dec;32(12):1458-1468. doi: 10.1007/s00380-017-1022-3. Epub 2017 Jul 13.
PubMed 28702898Friede A, O'Carroll PW, Thralls RB, Reid JA. CDC WONDER on the Web. Proc AMIA Annu Fall Symp. 1996:408-12.
PubMed 8947698Erkilic E, Kesimci E, Soykut C, Doger C, Gumus T, Kanbak O. Factors associated with preoperative anxiety levels of Turkish surgical patients: from a single center in Ankara. Patient Prefer Adherence. 2017 Feb 28;11:291-296. doi: 10.2147/PPA.S127342. eCollection 2017.
PubMed 28280304Chen SB, Hu H, Gao YS, He HY, Jin DX, Zhang CQ. Prevalence of clinical anxiety, clinical depression and associated risk factors in chinese young and middle-aged patients with osteonecrosis of the femoral head. PLoS One. 2015 Mar 19;10(3):e0120234. doi: 10.1371/journal.pone.0120234. eCollection 2015.
PubMed 25789850Afrassa N, Nega Kassa R, Girma Legesse T. Preoperative anxiety and its associated factors among patients undergoing cardiac catheterization at saint peter Specialized Hospital and Addis Cardiac Center, Addis Ababa, Ethiopia. International Journal of Africa Nursing Sciences. 2022/01/01/ 2022;17:100430. doi:https://doi.org/10.1016/j.ijans.2022.100430
Trotter R, Gallagher R, Donoghue J. Anxiety in patients undergoing percutaneous coronary interventions. Heart Lung. 2011 May-Jun;40(3):185-92. doi: 10.1016/j.hrtlng.2010.05.054. Epub 2010 Aug 17.
PubMed 20723986Kokalj Palandacic A, Ucman S, Novak Sarotar B, Lainscak M. The manifestation of anxiety in patients undergoing elective coronary angiography. Eur Psychiatry. 2023 Jul 19;66(Suppl 1):S69. doi: 10.1192/j.eurpsy.2023.233. eCollection 2023 Mar.
Y.B W, G.L F, H.T Y, A.G H. Prevalence and factors associated with preoperative anxiety among elective surgical patients at University of Gondar Hospital. Gondar, Northwest Ethiopia, 2017. A cross-sectional study. International Journal of Surgery Open. 2018/01/01/ 2018;10:21-29. doi:https://doi.org/10.1016/j.ijso.2017.11.001
Crockett JK, Gumley A, Longmate A. The development and validation of the Pre-operative Intrusive Thoughts Inventory (PITI). Anaesthesia. 2007 Jul;62(7):683-9. doi: 10.1111/j.1365-2044.2007.05090.x.
PubMed 17567344
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Perioperative Anxiety Among Patients Undergoing Coronary Angiography or Angioplasty: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06531252
- Acronym / sponsor ID
- 83/GCN-HĐĐĐ
- Conditions
- Anxiety
- Keywords
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 31 Jul 2024 (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.
Anxiety is defined as apprehension, tension, or uneasiness that originates from the danger which may be internal or external. Anxiety may manifest with symptoms related to behavior, emotions, and cognition. Anxiety is prevalent in patients before interventional procedures and deteriorates postoperative outcomes, for example, elevated level of postoperative pain, increased infection rate, and high mortality rate.
Coronary artery disease is one of the leading causes of mortality, disability, and workforce loss, resulting from the narrowing or obstruction of one or more branches of the coronary arteries due to the accumulation of atherosclerotic plaques. Coronary angiogram and angioplasty are among the most popular diagnostic and treatment tools available to cardiologists. However, patients and their families often experience anxiety before the procedure due to inadequate psychological preparation.
The majority of research about perioperative anxiety focused on surgery. Magnitude of preoperative anxiety as reported in some studies was in the range of 60-80% in the western population while some researchers showed a wider range, which was 11-80%. However, there is a lack of research reporting the prevalence of anxiety among patients arranged for minimally invasive procedures, especially coronary procedures. To the best of our knowledge, a cross-sectional study conducted in Africa among 267 cardiac patients found that 70.4% of them experienced perioperative anxiety. In contrast, similar studies reported that this figure was 35.0% in Europe and 35.7% in Australia. There was significant variation of anxiety level across countries. As a result, it is unacceptable to extrapolate the magnitude of anxiety in one nation to another with different socio-demographic characteristics, healthcare systems and family support. Moreover anxiety levels before surgery are influenced by various factors such as individual susceptibility, age, gender, prior surgical experiences, education, type and complexity of the surgery, current health condition, and socioeconomic status. Identifying risk factors helps healthcare provider to support psychological services during the preoperative visit so that stress can be reduced. Thus, the aim of this study was to evaluate the extent of preoperative anxiety among Vietnamese patients and explore the factors associated with it within the context of Asian culture.
Detailed description
This is a cross-sectional study conducted at University Medical Center Ho Chi Minh City. The patients were included in our study when patients were more than 18 years old and were able to comprehend Vietnamese language. The patients were excluded from study if the patients were unconscious and not oriented. On the procedural day, when the patients were in waiting room at DSA unit, investigators distributed a self-administer questionnaire to patients who had accepted to participate. The questionnaire is constructed from three parts, namely, demographics, perioperative factors, and the anxiety scale. Investigators employed "The Pre-operative Intrusive Thoughts Inventory (PITI)" as a tool to measure the anxiety scale. PITI 20 comprises twenty questions. This valid and reliable tool has Cronbach's Alpha score of 0.91. The English questionnaire was adapted and translated into the Vietnamese language and back to English. The answers contain 4 response options (4-point Likert scale ranging from "not at all" with 0 points, "some of the time" with 1 point, "often" with 2 points, and "most of the time" with 3 points). 0 and 60 points are the highest and lowest score respectively, the author of the tool reported that patients with 15 or more scores on the PITI-20 scale reliably were classified as high preoperative anxiety while participants who scored less than fifteen were classified as low preoperative anxiety. Section A: Demographic characteristics (8 questions) Section B: perioperative factors (4 questions) Section C: Pre-operative Intrusive Thoughts Inventory (PITI) anxiety scale (20 questions).
Categorical and nominal variables were presented as percentages and continuous variables as means and standard deviations. Noncontinuous variables were compared using the chi-square test and continuous variables using Student's t-test. Independent variables were identified via logistic regression. A two-sided p-value of <0.05 was considered to indicate statistical significance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- On the procedural day, when the patients were in waiting room at DSA unit, investigators distributed a self-administer questionnaire to patients who had accepted to participate
Key inclusion criteria (1 listed)
- The patients were included in our study when the patients were more than 18 years old and were able to comprehend Vietnamese language.
Key exclusion criteria (1 listed)
- The patients were excluded from our study if the patients were unconscious and not oriented
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
The proportion of participants with perioperative anxiety as assessed by "The Pre-operative Intrusive Thoughts Inventory (PITI)"
Time frame: 08/2022 - 07/2024
"The Pre-operative Intrusive Thoughts Inventory (PITI)" was employed. PITI 20, comprises twenty questions.The English questionnaire was adapted and translated into the Vietnamese language and back to English. The answers contain 4 response options (4-point Likert scale ranging from "not at all" with 0 points, "some of the time" with 1 point, "often" with 2 points, and "most of the time" with 3 points). 0 and 60 points are the highest and lowest score respectively, the author of the tool reported that patients with 15 or more scores on the PITI-20 scale reliably were classified as high preoperative anxiety while participants who scored less than fifteen were classified as low preoperative anxiety.
Identify demographic characteristics and perioperative factors related to perioperative anxiety
Time frame: 08/2022 - 07/2024
Demographic and perioperative factors are age, gender, marital status, occupation, educational status, average monthly income, locality, living situation, previous hospitalization, previous coronary angiography/angioplasty, pre-procedural anesthesia information, indication-to-procedure duration (hours). Logistic regression analysis was employed to indentify which variables were related to perioperative anxiety (according to PITI 20 score) independently.
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 31 Jul 2024.
- Background: PubMed 23063345Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araujo-Soares V. Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study. J Pain. 2012 Nov;13(11):1045-57. doi: 10.1016/j.jpain.2012.07.014. Epub 2012 Oct 12.
- Background: PubMed 16915080Starkweather AR, Witek-Janusek L, Nockels RP, Peterson J, Mathews HL. Immune function, pain, and psychological stress in patients undergoing spinal surgery. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E641-7. doi: 10.1097/01.brs.0000231795.85409.87.
- Background: PubMed 28702898Takagi H, Ando T, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels. 2017 Dec;32(12):1458-1468. doi: 10.1007/s00380-017-1022-3. Epub 2017 Jul 13.
- Background: PubMed 8947698Friede A, O'Carroll PW, Thralls RB, Reid JA. CDC WONDER on the Web. Proc AMIA Annu Fall Symp. 1996:408-12.
- Background: PubMed 28280304Erkilic E, Kesimci E, Soykut C, Doger C, Gumus T, Kanbak O. Factors associated with preoperative anxiety levels of Turkish surgical patients: from a single center in Ankara. Patient Prefer Adherence. 2017 Feb 28;11:291-296. doi: 10.2147/PPA.S127342. eCollection 2017.
- Background: PubMed 25789850Chen SB, Hu H, Gao YS, He HY, Jin DX, Zhang CQ. Prevalence of clinical anxiety, clinical depression and associated risk factors in chinese young and middle-aged patients with osteonecrosis of the femoral head. PLoS One. 2015 Mar 19;10(3):e0120234. doi: 10.1371/journal.pone.0120234. eCollection 2015.
- BackgroundAfrassa N, Nega Kassa R, Girma Legesse T. Preoperative anxiety and its associated factors among patients undergoing cardiac catheterization at saint peter Specialized Hospital and Addis Cardiac Center, Addis Ababa, Ethiopia. International Journal of Africa Nursing Sciences. 2022/01/01/ 2022;17:100430. doi:https://doi.org/10.1016/j.ijans.2022.100430
- Background: PubMed 20723986Trotter R, Gallagher R, Donoghue J. Anxiety in patients undergoing percutaneous coronary interventions. Heart Lung. 2011 May-Jun;40(3):185-92. doi: 10.1016/j.hrtlng.2010.05.054. Epub 2010 Aug 17.
- BackgroundKokalj Palandacic A, Ucman S, Novak Sarotar B, Lainscak M. The manifestation of anxiety in patients undergoing elective coronary angiography. Eur Psychiatry. 2023 Jul 19;66(Suppl 1):S69. doi: 10.1192/j.eurpsy.2023.233. eCollection 2023 Mar.
- BackgroundY.B W, G.L F, H.T Y, A.G H. Prevalence and factors associated with preoperative anxiety among elective surgical patients at University of Gondar Hospital. Gondar, Northwest Ethiopia, 2017. A cross-sectional study. International Journal of Surgery Open. 2018/01/01/ 2018;10:21-29. doi:https://doi.org/10.1016/j.ijso.2017.11.001
- Background: PubMed 17567344Crockett JK, Gumley A, Longmate A. The development and validation of the Pre-operative Intrusive Thoughts Inventory (PITI). Anaesthesia. 2007 Jul;62(7):683-9. doi: 10.1111/j.1365-2044.2007.05090.x.
- 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, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 1 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 31 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 Vietnam. 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?
The proportion of participants with perioperative anxiety as assessed by "The Pre-operative Intrusive Thoughts Inventory (PITI)" (time frame: 08/2022 - 07/2024). 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 NCT06531252, which also lists 11 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 31 Jul 2024.