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

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT03958578
Collaborator
(none)
90
Enrollment
1
Location
7
Actual Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    90 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
    Actual Primary Completion Date :
    Dec 1, 2019
    Actual Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. State-Trait Anxiety Inventory questionnaire [20-30 minutes.]

      State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients aged between 18 and 55 years.

    • ASA I-II

    • BMI 18-25

    Exclusion Criteria:
    • Major surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yadigar Yılmaz Istanbul Turkey 34230

    Sponsors and Collaborators

    • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yadigar Yılmaz, Medical Doctor, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
    ClinicalTrials.gov Identifier:
    NCT03958578
    Other Study ID Numbers:
    • OKMEYDANI EAH 48670771-514.10
    First Posted:
    May 22, 2019
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Nov 23, 2021