Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients

Not Applicable

Completed

• Conditions: Anxiety; Blood Pressure; Hypertension
• Interventions: Behavioral: Group IORE

• Registration Number: NCT03711201
• Lead Sponsor: Yuzuncu Yıl University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Study Start: 2018-10-30
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-01
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group IORE	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.

Primary Outcome Measures

Name	Time	Method
anxiety	1 day	The patient's anxiety will be measured by instantaneous state anxiety scale (ST-STAI)

Trial Locations

Locations (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center; 🇹🇷 Van, Turkey