Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

Not Applicable

• Conditions: Gall Stones
• Interventions: Behavioral: surgery education; Behavioral: relaxation program

• Registration Number: NCT02481271
• Lead Sponsor: Universität Duisburg-Essen

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

Study Timeline

• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Study Start: 2015-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
preoperative surgery education	surgery education	single education unit to understand the complete surgical procedures
preoperative relaxation program	relaxation program	preoperative relaxation program
preoperative relaxation program+preoperative surgery education	relaxation program	preoperative relaxation program AND single education unit
preoperative relaxation program+preoperative surgery education	surgery education	preoperative relaxation program AND single education unit

Primary Outcome Measures

Name	Time	Method
preoperative anxiety	day of surgery	State Anxiety (STAI-S) (Spielberger 1970)
postoperative pain intensity	day after the surgery, before meditation	numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

Secondary Outcome Measures

Name	Time	Method
preoperative anxiety	day of surgery	Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
postoperative disability	10 days after surgery	interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative fatigue	10 days after surgery	Fatigue measured by 0-10 Numeric Rating Scale
postoperative nausea	10 days after surgery	Nausea measured by 0-10 Numeric Rating Scale
postoperative complications	10 days after surgery	postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever
Satisfaction with care	10 days after surgery	Satisfaction with the operation, the hospital care
Satisfaction with interventions	10 days after surgery	Satisfaction with the interventions

Trial Locations

Locations (1)

Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen; 🇩🇪 Duisburg, Germany