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