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Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients

Primary Purpose

Hypertension, Anxiety, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group IORE
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Hypertensive patients, Introduction of operating room, Anxiety, Blood pressure

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Van yuzuncu Yıl University, Dursun Odabas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group IORE

Group NoIORE

Arm Description

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.

The patient's hemodynamic data will be measured in the evening service before surgery. The patient will be brought to the operating room by the anesthesiologist on the day of surgery and hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured in the preop unit. The hemodynamic data and the ST-STAI scale will measure the anxiety level in the operating room.

Outcomes

Primary Outcome Measures

anxiety
The patient's anxiety will be measured by instantaneous state anxiety scale (ST-STAI)

Secondary Outcome Measures

Full Information

First Posted
October 12, 2018
Last Updated
December 1, 2018
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT03711201
Brief Title
Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Anxiety, Blood Pressure
Keywords
Hypertensive patients, Introduction of operating room, Anxiety, Blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group IORE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group NoIORE
Arm Type
No Intervention
Arm Description
The patient's hemodynamic data will be measured in the evening service before surgery. The patient will be brought to the operating room by the anesthesiologist on the day of surgery and hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured in the preop unit. The hemodynamic data and the ST-STAI scale will measure the anxiety level in the operating room.
Intervention Type
Behavioral
Intervention Name(s)
Group IORE
Intervention Description
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 Measure Information:
Title
anxiety
Description
The patient's anxiety will be measured by instantaneous state anxiety scale (ST-STAI)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nureddin Yüzkat
Organizational Affiliation
Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey
Official's Role
Study Chair
Facility Information:
Facility Name
Van yuzuncu Yıl University, Dursun Odabas Medical Center
City
Van
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21346166
Citation
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.
Results Reference
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PubMed Identifier
8942601
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. doi: 10.1097/00000539-199612000-00027.
Results Reference
background
PubMed Identifier
10024070
Citation
Paterniti S, Alperovitch A, Ducimetiere P, Dealberto MJ, Lepine 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. doi: 10.1097/00006842-199901000-00013.
Results Reference
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Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients

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