NCT03711201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

Same day

First QC Date

October 12, 2018

Last Update Submit

December 1, 2018

Conditions

HypertensionAnxietyBlood Pressure

Keywords

Hypertensive patientsIntroduction of operating roomAnxietyBlood pressure

Outcome Measures

Primary Outcomes (1)

  • anxiety

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

    1 day

Study Arms (2)

Group IORE

ACTIVE COMPARATOR

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.

Behavioral: Group IORE

Group NoIORE

NO INTERVENTION

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.

Interventions

Group IOREBEHAVIORAL

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.

Group IORE

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective surgery
  • informed consent,
  • essential hypertension was diagnosed,
  • Between the ages of 40-80,
  • American Society of Anesthesiologists (ASA) class II-III

You may not qualify if:

  • drug allergy,
  • with a history of malignant hyperthermia,
  • uncontrolled hypertension,
  • cancer and psychological problems,
  • patients with cardiac and endocrine diseases
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, Turkey (Türkiye)

Location

Related 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.

    PMID: 21346166BACKGROUND

  • 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.

    PMID: 8942601BACKGROUND

  • 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.

    PMID: 10024070BACKGROUND

MeSH Terms

Conditions

HypertensionAnxiety Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMental Disorders

Study Officials

  • Nureddin Yüzkat

    Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. prof.

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 18, 2018

Study Start

October 30, 2018

Primary Completion

October 30, 2018

Study Completion

November 30, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

TU(1)