Clinical trial NCT02476370: Effects of Preoperative Relaxation and Intensified Surgery Education in Patients Undergoing Herniotomy
Official title: Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Herniotomy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Anxiety
Postoperative Pain
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Herniotomy.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* referral for herniotomy
* preoperative anxiety at least 4/10 points on a numeric rating scale
* physical and mental capability to participant
* written informed consent

Exclusion Criteria:

* Emergency surgery
* malignoma
* recurrence of inaugural hernia
* severe comorbidity
* severy psychological disorders
* immunosuppression
* coagulation disorders

Primary outcomes:
measure: preoperative anxiety (State Anxiety (STAI-S)
timeFrame: day of surgery
measure: postoperative pain intensity (numeric rating scale)
timeFrame: day after the surgery, before medication
Secondary outcomes:
measure: preoperative anxiety Trait Anxiety (STAI-T)
timeFrame: day of surgery
measure: preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: day of surgery
measure: preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA)
timeFrame: day of surgery
measure: postoperative disability
timeFrame: day after surgery
measure: postoperative disability
timeFrame: 2 days after surgery
measure: postoperative disability
timeFrame: 10 days after surgery
measure: postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale
timeFrame: Day after surgery
measure: postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale
timeFrame: 2 days after surgery
measure: postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale
timeFrame: 10 days after surgery
measure: postoperative nausea Nausea measured by 0-10 Numeric Rating Scale
timeFrame: Day after surgery
measure: postoperative nausea Nausea measured by 0-10 Numeric Rating Scale
timeFrame: 2 days after surgery
measure: postoperative nausea Nausea measured by 0-10 Numeric Rating Scale
timeFrame: 10 days after surgery
measure: postoperative complications
timeFrame: 10 days after surgery
measure: Satisfaction with care
timeFrame: 10 days after surgery
measure: Satisfaction with interventions
timeFrame: 10 days after surgery
Other outcomes:
measure: course of surgery
timeFrame: day of surgery
Locations:
city: Duisburg
country: Germany
facility: Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
name: Gustav Dobos, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omlor G, Kiewitz S, Pietschmann S, Roesler S. [Effect of preoperative preoperative visualization therapy on postoperative outcome after inguinal hernia surgery and thyroid resection]. Zentralbl Chir. 2000;125(4):380-5; discussion 385-6. German.