|- candidate number||23981|
|- NTR Number||NTR5785|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-feb-2016|
|- Secondary IDs||2016-2400. METC|
|- Public Title||Effect of a decision aid about postoperative epidural analgesia on patients' knowledge: a randomized controlled trial.|
|- Scientific Title||Effect of a decision aid about postoperative epidural analgesia on patients' knowledge: a randomized controlled trial.|
|- hypothesis||A decision aid about postoperative epidural analgesia will improve patients' knowledge.|
|- Healt Condition(s) or Problem(s) studied||Pre-operative, Postoperative analgesia|
|- Inclusion criteria||Adults.|
Major thoracic or abdominal surgery.
Indication for epidural postoperative analgesia.
|- Exclusion criteria||Age < 18 years.|
No indication for epidural postoperative analgesia.
Contraindication for epidural analgesia.
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2016|
|- planned closingdate||1-jan-2016|
|- Target number of participants||300|
|- Interventions||Decision aid about postoperative analgesia|
|- Primary outcome||Knowledge|
|- Secondary outcome||Preferred and perceived participation.|
|- Timepoints||Baseline (T1) directly before the preoperative consultation.
T2 directly after the consultation with the anaesthesiologist.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Amy van den Berg|
|- CONTACT for SCIENTIFIC QUERIES|| Amy van den Berg|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Centre Nijmegen|
|- Brief summary||During preoperative consultations not all aspects of the postoperative analgesia treatments are presented in detail and shared decision-making is not always applied. To improve informed participation of patients, a decision aid was developed concerning postoperative analgesia. The present study was primary designed to evaluate the effectiveness of this decision aid in a randomized controlled trial on knowledge of participants.|
|- Main changes (audit trail)|
|- RECORD||17-feb-2016 - 28-mei-2016|