Primary Objective: Establishing the course of surgical fear, assessed by the surgical fear questionnaire at multiple time points, from one week before surgery until the day of surgery. Secondary Objectives: • Establishing the convergent…
ID
Bron
Verkorte titel
Aandoening
Cataract, surgical fear; staaroperatie, preoperatieve angst
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
SFQ scores measured at timepoints 1, 2, 3, and 4
Achtergrond van het onderzoek
Validation of the Surgical Fear Questionnaire (SFQ) has recently been established. However, all studies used for validation applied the SFQ only at one single time point, and information on convergent validity of the SFQ, as a subjective instrument, with a biological index of fear is lacking.
The aim of this observational study is to establish the course of surgical fear, assessed by the SFQ at multiple time points and to establish the convergent validity of the SFQ with salivary cortisol and alpha amylase levels. Furthermore the patient preferences for preoperative treatment of surgical fear are assessed, and SFQ scores of the first and second cataract surgery are compared.
Primary outcome measure:
SFQ scores measured at one week before first surgery, the day before first surgery, the day of first surgery and the day before second surgery.
Secondary outcomes:
Salivary cortisol and alpha amylase levels, the NRS fear score, retrospective evaluation of SFQ score, preferences for surgical fear treatment, surgical recovery , and postsurgical pain.
Population:
Adult cataract surgery patients (N=102).
Doel van het onderzoek
Primary Objective:
Establishing the course of surgical fear, assessed by the surgical fear questionnaire at multiple time points, from one week before surgery until the day of surgery.
Secondary Objectives:
• Establishing the convergent validity of the SFQ with two biological indexes of stress/anxiety, salivary cortisol and salivary alpha amylase.
• Assessing patient preferences for preoperative treatment of surgical fear
• Comparing SFQ scores of the first versus the second cataract surgery.
Onderzoeksopzet
1. one week before first surgery
2. the day before first surgery
3. the day of first surgery
4. the day before second surgery
5. four weeks after (second) surgery
Onderzoeksproduct en/of interventie
Not applicable
Algemeen / deelnemers
Anaesthesiology
P. Debyelaan 25
H.M.S. Theunissen
Maastricht 6229 HX
The Netherlands
+31 (0)43 3876543
maurice.theunissen@mumc.nl
Wetenschappers
Anaesthesiology
P. Debyelaan 25
H.M.S. Theunissen
Maastricht 6229 HX
The Netherlands
+31 (0)43 3876543
maurice.theunissen@mumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4253 |
NTR-old | NTR4491 |
Ander register | METC azM/UM : 13-4-098 |