Perioperative Stress and Pain Perception of Second Eye Cataract Surgery
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional other trial for Cataract focused on measuring Cataract, Cataract surgery, Biofeedback
Eligibility Criteria
Inclusion Criteria:
- Age 21 and older
- written informed consent prior to surgery
- bilateral age-related cataract
Exclusion Criteria:
- deafness
- allergy to topical anesthetic agents
- severe anxiety and involuntary eye and head movements
- conditions likely to require surgical therapy other than routine phacoemulsification (eg: traumatic and complicated cataracts)
- in case of pregnancy (pregnancy test will be taken in women of reproductive age)
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biofeedback measurement
Arm Description
A Biofeedback measurement will be done during cataract surgery of both eyes
Outcomes
Primary Outcome Measures
Perioperative agitation (stress) measurement
Perioperative stress will be measured using the BioLink Biofeedback device, which records an electrocardiogram, an electromyogram, skin conductance and respiratory rate. Changes in the different values show how stressed the patient was during the surgeries.
Secondary Outcome Measures
Assessment of pain perception
Pain perception of the patients will be assessed during the two cataract surgeries using an visual analogue scale, where 10 means highest pain and 1 is lowest pain.
Full Information
NCT ID
NCT03749759
First Posted
November 20, 2018
Last Updated
February 26, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03749759
Brief Title
Perioperative Stress and Pain Perception of Second Eye Cataract Surgery
Official Title
Pain Perception and Discomfort of Second Eye Cataract Surgery in Comparison With the First Eye in Correlation With Perioperative Stress
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Purpose of this study is to find a correlation between agitation (stress) indicating parameters and the pain perception during second eye cataract surgery, compared to first eye cataract surgery.
Detailed Description
A cataract, which is the clouding of the eye's natural lens as a result of aging or injury, is the leading cause of preventable blindness worldwide. As one of the of the most common surgical procedures, cataract surgery is performed almost 22 million times worldwide each year. The World Health Organisation estimates that by 2020 more than 32 million cataract surgeries will take place globally per annum.
Phacoemulsification cataract surgery in topical anaesthesia has become the anaesthetic method of choice since first described by Fichman in 1992. Although this procedure has proven to be relatively painless, safe and effective, patients often report increased pain or discomfort during surgery of the second eye. Several studies were performed to find out if there was any proof to that common finding and some tried to find a correlation to fear and anxiety using standardized questionnaires.
In one study of 65 patients there was a subtle increase in pain in the second surgery relative to the first which appeared to be associated with decreased preoperative anxiety. Another study found that previous cataract extraction correlated negatively, but weakly with preoperative anxiety.
A study of 70 patients having first cataract extraction found no difference in mean pain scores, fear and anxiety when compared with a second, independent population of 57 patients having second cataract extraction. A similar outcome was found in 2 other studies where there was no difference in perceived pain between the first and second cataract surgery.
Summarized, the results in the related literature are controversial concerning the assessment of pain, fear and anxiety during cataract surgery performed in the second eye.
Emotional stress and anxiety in surgical patients lead to sympathetic stimulation with tachycardia, hypertension and possible cardiac ischaemia which are haemodynamic stress responses, triggered by endocrine regulatory mechanisms and the autonomic nervous system with increased cortisol, adrenaline and noradrenaline blood levels. Furthermore palmar and plantar sweat glands activity decreases skin resistance which is shown as a surge in electric skin conductance in bio- feedback measurements.
For obtaining and processing the information about these physiological reactions a system with the ability to measure and record various bio-signals is needed. These kind of systems are used for biofeedback. Galvanic Skin response Sensors measure the above mentioned electrical conductance of the skin. It is used as an indication of psychological and physiological excitation and thus represents an indicator for the individual's stress response.
Electromyograph (EMG) uses surface electrodes to measure the electrical activity of the skeletal muscles when they are relaxed and contracted by detecting the combined electrical potential generated by the muscle cells. The mean value of the rectified EMG signal of the upper trapezius muscle increases during stressful conditions and decreases again during relaxation periods.
Electrocardiogram (ECG) electrodes are used to measure the heart function and further calculate the heart rate variability (HRV). HRV is defined as the beat-to-beat changes, the interbeat interval, which is the time between two successive R waves. HRV is considered as a measure of the interaction between sympathetic and parasympathetic influence on heart rate. The activation of the sympathetic branch of the autonomic nervous system increases heart rate, while the activation of the parasympathetic branch, primarily mediated by the vagus nerve, slows it. These physiological signals provide a reliable measurement of agitation (stress).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Cataract surgery, Biofeedback
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback measurement
Arm Type
Experimental
Arm Description
A Biofeedback measurement will be done during cataract surgery of both eyes
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
A biofeedback measurement will be carried out during cataract surgery of both eyes
Primary Outcome Measure Information:
Title
Perioperative agitation (stress) measurement
Description
Perioperative stress will be measured using the BioLink Biofeedback device, which records an electrocardiogram, an electromyogram, skin conductance and respiratory rate. Changes in the different values show how stressed the patient was during the surgeries.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of pain perception
Description
Pain perception of the patients will be assessed during the two cataract surgeries using an visual analogue scale, where 10 means highest pain and 1 is lowest pain.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 21 and older
written informed consent prior to surgery
bilateral age-related cataract
Exclusion Criteria:
deafness
allergy to topical anesthetic agents
severe anxiety and involuntary eye and head movements
conditions likely to require surgical therapy other than routine phacoemulsification (eg: traumatic and complicated cataracts)
in case of pregnancy (pregnancy test will be taken in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Falasinnu, MD
Phone
01 91021-57559
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Kefer
Phone
01 91021-57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Falasinnu, MD
Phone
01 910 21-57559
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Katharina Kefer
Phone
01 910 21-57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Perioperative Stress and Pain Perception of Second Eye Cataract Surgery
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