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Clinical Trials/NCT02481271
NCT02481271
Unknown
Not Applicable

Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial

Universität Duisburg-Essen1 site in 1 country108 target enrollmentDecember 2015
ConditionsGall Stones

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gall Stones
Sponsor
Universität Duisburg-Essen
Enrollment
108
Locations
1
Primary Endpoint
preoperative anxiety
Last Updated
8 years ago

Overview

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 Cholecystectomy.

Detailed Description

see above

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gustav Dobos

Principle Investigator

Universität Duisburg-Essen

Eligibility Criteria

Inclusion Criteria

  • 18 years old
  • referral for cholecystectomy
  • 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
  • severe comorbidity
  • severe psychological disorders
  • immunosuppression
  • coagulation disorders

Outcomes

Primary Outcomes

preoperative anxiety

Time Frame: day of surgery

State Anxiety (STAI-S) (Spielberger 1970)

postoperative pain intensity

Time Frame: day after the surgery, before meditation

numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

Secondary Outcomes

  • preoperative anxiety(day of surgery)
  • postoperative disability(10 days after surgery)
  • postoperative fatigue(10 days after surgery)
  • postoperative nausea(10 days after surgery)
  • postoperative complications(10 days after surgery)
  • Satisfaction with care(10 days after surgery)
  • Satisfaction with interventions(10 days after surgery)

Study Sites (1)

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