Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients

Hypertension Clinical Trial

Official title:

The Effects of the Preoperative Operating Room Environment Presentation on Preanesthetic Anxiety and Blood Pressure in Hypertensive Patients: A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711201
• Other study ID #: Hypertensive patients
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2018
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the effects of preoperative operating room environment introduction on preoperative hypertension and blood pressure in hypertensive patients.

Description:

Procedure to be Applied:

In order to eliminate the other factors that cause essential HT, the patients' blood pressure due to HT should be controlled, the surgery will be planned as the first case in the morning and the patients will need 8 hours fasting period.

Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will be recorded. Hemodynamic parameters (blood pressure, heart rate and SpO2 values) will be recorded in the services of the patients, in the preop unit and in the operation room. Hypertension requiring intervention or additional medication will be excluded from the study. A randomized number of patients will be included in the study according to the results of power analysis.

Introduction of the operating room environment (IORE): The procedure to be performed on the day of surgery will be simulated and accompanied by an anesthesiologist. The patient's hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the time of operation, between 16: 00-18: 00 hours prior to the operation, and will be brought to the operating room with a service nurse. The hemodynamic data of the patient will be measured in the preop unit and the patient will be taken to the operating room with anesthesia doctor. Here, in addition to the patient's hemodynamic data, the instantaneous state anxiety scale (ST-STAI) will be completed and the patient will be left in service again. The procedure will be similar to the process that the patient will experience on the operation day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• elective surgery

• informed consent,

• essential hypertension was diagnosed,

• Between the ages of 40-80,

• American Society of Anesthesiologists (ASA) class II-III

Exclusion Criteria:

• drug allergy,

• with a history of malignant hyperthermia,

• uncontrolled hypertension,

• cancer and psychological problems,

• patients with cardiac and endocrine diseases

• emergency surgery

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Blood Pressure
• Hypertension

Intervention

Behavioral:
• Group IORE
This group will undergo the IORE procedure before surgery (operation). On the day of surgery, the patient will be brought to the operating room by the anesthesiologist. Hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the service, preop unit and operating room. The anxiety level in the operating room will be measured by the ST-STAI scale.

Locations

Country	Name	City	State
Turkey	Van yuzuncu Yil University, Dursun Odabas Medical Center	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kakinuma A, Nagatani H, Otake H, Mizuno J, Nakata Y. The effects of short interactive animation video information on preanesthetic anxiety, knowledge, and interview time: a randomized controlled trial. Anesth Analg. 2011 Jun;112(6):1314-8. doi: 10.1213/ANE.0b013e31820f8c18. Epub 2011 Feb 23. — View Citation

Paterniti S, Alpérovitch A, Ducimetière P, Dealberto MJ, Lépine JP, Bisserbe JC. Anxiety but not depression is associated with elevated blood pressure in a community group of French elderly. Psychosom Med. 1999 Jan-Feb;61(1):77-83. — View Citation

Shafer A, Fish MP, Gregg KM, Seavello J, Kosek P. Preoperative anxiety and fear: a comparison of assessments by patients and anesthesia and surgery residents. Anesth Analg. 1996 Dec;83(6):1285-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety	The patient's anxiety will be measured by instantaneous state anxiety scale (ST-STAI)	1 day