Perioperative Anxiety Among Patients Undergoing Coronary Angiography or Angioplasty

NCT06531252 | Completed DMC

• 1 other identifier: 83/GCN-HĐĐĐ
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety

Keywords

Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  08/2022 - 07/2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• The patients were included in our study when the patients were more than 18 years old and were able to comprehend Vietnamese language.

You may not qualify if:

• The patients were excluded from our study if the patients were unconscious and not oriented

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center

Ho Chi Minh City, 59000, Vietnam

Location

Related Publications (11)

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• Takagi 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.

  PMID: 28702898 BACKGROUND

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  PMID: 8947698 BACKGROUND

• Erkilic 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.

  PMID: 28280304 BACKGROUND

• Chen 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.

  PMID: 25789850 BACKGROUND

• Afrassa 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

• 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.

  PMID: 20723986 BACKGROUND

• Kokalj 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17567344 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 15, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)