Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03958578
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief Summary:
Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.

Condition or disease
Anxiety

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. State-Trait Anxiety Inventory questionnaire [ Time Frame: 20-30 minutes. ]
    State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 55 years.
  • ASA I-II
  • BMI 18-25

Exclusion Criteria:

  • Major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958578


Locations
Layout table for location information
Turkey
Yadigar Yılmaz Recruiting
Istanbul, Turkey, 34230
Contact: Yadigar Yılmaz    5053069924    dryadigaryilmaz@gmail.com   
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Layout table for additonal information
Responsible Party: Yadigar Yılmaz, Medical Doctor, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT03958578     History of Changes
Other Study ID Numbers: OKMEYDANI EAH 48670771-514.10
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders