MedPath

Onderzoek beleving staaroperatie

Recruiting
Conditions
Cataract, surgical fear
staaroperatie, preoperatieve angst
Registration Number
NL-OMON22026
Lead Sponsor
Maastricht University Medical Center (MUMC+)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
102
Inclusion Criteria

• Age > 18 years
• Elective cataract surgery (one or both eyes)
• Day surgery setting
• Waiting list > 1 week
• (Loco-)regional anesthesia
• Good command of Dutch language
• Informed consent
• ASA-classification I-III

Exclusion Criteria

• Cataract surgery of first eye already performed last year
• Illiteracy
• Cognitive impairment (as indicated in the medical record)
• General anesthesia
• Corticosteroid use (except inhaler)
• M. Cushing, Addison’s disease, Hypo-/Hyperthyroid
• ASA-classification IV
• Participation in another clinical trial

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
SFQ scores measured at timepoints 1, 2, 3, and 4
Secondary Outcome Measures
NameTimeMethod
• salivary cortisol measured at time points 1,2,3, and 5. At all time points three samples will be taken: morning after awakening, afternoon 15:00-16:00hrs, evening 20:00-21:00hrs. At time point 3, the second and third sample are collected in-hospital pre- and postoperatively.<br>• Salivary alpha amylase, measured at time point 3 in the same saliva sample used for cortisol determination.<br>• NRS (0-10) fear score. On the day of surgery, together with the salivary samples a one-item fear score will be assessed.<br>• Retrospective evaluation of own surgical fear measured at timepoint 3 post-operatively on a five-point Likert scale. <br>• Preferences for treatment of surgical fear, assessed at time point 5. <br>• Surgical recovery, assesed at timepoint 5 with the Global Surgical Recovery (GSR)Scale (0-100%). Also postoperative pain will be assessed with a NRS score (0-10).
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