Clinical trial NCT02541357: Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery
Official title: Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Colorectal Surgery - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Diseases
Keywords: Colorectal Surgery
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 4
Sex: ALL
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 colorectal surgery.

Detailed description: A former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. However the intervention was biased by concurrent pre-surgery education. Therefore 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 colorectal surgery using a factorial design.

Eligibility criteria: Inclusion Criteria:

* referral for colorectal surgery
* 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
* known malignoma
* severe comorbidity
* severe psychological disorders
* immunosuppression
* coagulation disorders

Primary outcomes:
measure: preoperative anxiety
timeFrame: day of surgery
measure: postoperative pain intensity
timeFrame: day after the surgery, before meditation
Secondary outcomes:
measure: preoperative anxiety
timeFrame: day of surgery
measure: preoperative anxiety
timeFrame: day of surgery
measure: preoperative anxiety
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
timeFrame: day after surgery
measure: postoperative fatigue
timeFrame: 2 days after surgery
measure: postoperative fatigue
timeFrame: 10 days after surgery
measure: postoperative nausea
timeFrame: Day after surgery
measure: postoperative nausea
timeFrame: 2 days after surgery
measure: postoperative nausea
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:
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: