|- candidate number||17157|
|- NTR Number||NTR4491|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-apr-2014|
|- Secondary IDs||13-4-098 METC azM/UM|
|- Public Title||Onderzoek beleving staaroperatie|
|- Scientific Title||Preoperative course of surgical fear.
Assessment of the Surgical Fear Questionnaire (SFQ) at multiple time points and its convergent validity with salivary biomarkers.|
|- ACRONYM||SFQ at multiple time points|
|- hypothesis||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.
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.|
|- Healt Condition(s) or Problem(s) studied||Cataract surgery, Cataract, Preoperative anxiety|
|- Inclusion criteria|| Age > 18 years
Elective cataract surgery (one or both eyes)
Day surgery setting
Waiting list > 1 week
Good command of Dutch language
|- Exclusion criteria|| Cataract surgery of first eye already performed last year
Cognitive impairment (as indicated in the medical record)
Corticosteroid use (except inhaler)
M. Cushing, Addisons disease, Hypo-/Hyperthyroid
Participation in another clinical trial|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||13-feb-2014|
|- planned closingdate|
|- Target number of participants||102|
|- Interventions||Not applicable|
|- Primary outcome||SFQ scores measured at timepoints 1, 2, 3, and 4|
|- Secondary outcome|| 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).|
|- Timepoints||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|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. H.M.S. Theunissen|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Madelon Peters|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University, NWO VICI grant|
|- Brief summary||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.
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.
Adult cataract surgery patients (N=102).
|- Main changes (audit trail)|
|- RECORD||10-apr-2014 - 27-apr-2014|