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The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy

Primary Purpose

Kidney Transplantation, Anxiety, Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Donor Nephrectomy
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-II between 18-60 years
  • Donor Nephrectomy patients

Exclusion Criteria:

  • psychiatric disturbance
  • medicinal allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Donor Nephrectomy

    Arm Description

    Donor Nephrectomy

    Outcomes

    Primary Outcome Measures

    Postoperative Pain Intensity
    Patient's pain intensity as measured by visual analogue scale

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2017
    Last Updated
    April 24, 2017
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03131258
    Brief Title
    The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
    Official Title
    The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors. Donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1). Pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. Educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. In some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2). Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength. Post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). Providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5). There are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. There are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. Because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Transplantation, Anxiety, Pain, Acute, Anesthesia Recovery Period

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Donor Nephrectomy
    Arm Type
    Other
    Arm Description
    Donor Nephrectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Donor Nephrectomy
    Intervention Description
    48 Donor Nephrectomy Patients
    Primary Outcome Measure Information:
    Title
    Postoperative Pain Intensity
    Description
    Patient's pain intensity as measured by visual analogue scale
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA I-II between 18-60 years Donor Nephrectomy patients Exclusion Criteria: psychiatric disturbance medicinal allergy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erbil Türksal, MD
    Organizational Affiliation
    Ege University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy

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