Clinical Trial: Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: see above
Sponsor: Universität Duisburg-Essen

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • preoperative anxiety [ Time Frame: day of surgery ]
    Trait Anxiety (STAI-T) (Spielberger 1970)
  • preoperative anxiety [ Time Frame: day of surgery ]
    Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
  • preoperative anxiety [ Time Frame: day of surgery ]
    Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
  • postoperative disability [ Time Frame: day after surgery ]
    interference of pain with movement, coughing, waking up at night and disturbed mood
  • postoperative disability [ Time Frame: 2 days after surgery ]
    interference of pain with movement, coughing, waking up at night and disturbed mood
  • postoperative disability [ Time Frame: 10 days after surgery ]
    interference of pain with movement, coughing, waking up at night and disturbed mood
  • postoperative fatigue [ Time Frame: Day after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale
  • postoperative fatigue [ Time Frame: 2 days after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale
  • postoperative fatigue [ Time Frame: 10 days after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale
  • postoperative nausea [ Time Frame: Day after surgery ]
    Nausea measured by 0-10 Numeric Rating Scale
  • postoperative nausea [ Time Frame: 2 days after surgery ]
    Nausea measured by 0-10 Numeric Rating Scale
  • postoperative nausea [ Time Frame: 10 days after surgery ]
    Nausea measured by 0-10 Numeric Rating Scale
  • postoperative complications [ Time Frame: 10 days after surgery ]
    postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever
  • Satisfaction with care [ Time Frame: 10 days after surgery ]
    Satisfaction with the operation, the hospital care
  • Satisfaction with interventions [ Time Frame: 10 days after surgery ]
    Satisfaction with the interventions


Original Secondary Outcome: Same as current

Information By: Universität Duisburg-Essen

Dates:
Date Received: June 22, 2015
Date Started: December 2015
Date Completion: December 2016
Last Updated: January 7, 2016
Last Verified: January 2016