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
About this trial
This is an interventional treatment trial for Kidney Transplantation
Eligibility Criteria
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
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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