Onderzoek beleving staaroperatie

Preoperative course of surgical fear. Assessment of the Surgical Fear Questionnaire (SFQ) at multiple time points and its convergent validity with salivary biomarkers.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22026

Enrollment

102

Registered

2014-04-10

Start date

2014-02-13

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, surgical fear

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
SFQ scores measured at timepoints 1, 2, 3, and 4	—

Secondary

Measure	Time frame
• 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. • Salivary alpha amylase, measured at time point 3 in the same saliva sample used for cortisol determination. • NRS (0-10) fear score. On the day of surgery, together with the salivary samples a one-item fear score will be assessed. • Retrospective evaluation of own surgical fear measured at timepoint 3 post-operatively on a five-point Likert scale. • Preferences for treatment of surgical fear, assessed at time point 5. • 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).	—

Measure

Time frame

• 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. • Salivary alpha amylase, measured at time point 3 in the same saliva sample used for cortisol determination. • NRS (0-10) fear score. On the day of surgery, together with the salivary samples a one-item fear score will be assessed. • Retrospective evaluation of own surgical fear measured at timepoint 3 post-operatively on a five-point Likert scale. • Preferences for treatment of surgical fear, assessed at time point 5. • 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).

—

Contacts

Public ContactH.M.S. Theunissen

Maastricht University Medical Center+ (MUMC+) Anaesthesiology P. Debyelaan 25

maurice.theunissen@mumc.nl+31 (0)43 3876543

Outcome results