Back to resultsPreoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy (MBM_Galle)
Primary Purpose
Gall Stones
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
relaxation program
surgery education
Sponsored by
About this trial
This is an interventional prevention trial for Gall Stones focused on measuring cholecystectomy
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
Sites / Locations
- Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus RheinhausenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Usual care
preoperative relaxation program
preoperative surgery education
preoperative relaxation program+preoperative surgery education
Arm Description
Does not receive a specific study intervention
preoperative relaxation program
single education unit to understand the complete surgical procedures
preoperative relaxation program AND single education unit
Outcomes
Primary Outcome Measures
preoperative anxiety
State Anxiety (STAI-S) (Spielberger 1970)
postoperative pain intensity
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
Secondary Outcome Measures
preoperative anxiety
Trait Anxiety (STAI-T) (Spielberger 1970)
preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
preoperative anxiety
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
postoperative complications
postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever
Satisfaction with care
Satisfaction with the operation, the hospital care
Satisfaction with interventions
Satisfaction with the interventions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02481271
Brief Title
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy
Acronym
MBM_Galle
Official Title
Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Stones
Keywords
cholecystectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Does not receive a specific study intervention
Arm Title
preoperative relaxation program
Arm Type
Experimental
Arm Description
preoperative relaxation program
Arm Title
preoperative surgery education
Arm Type
Experimental
Arm Description
single education unit to understand the complete surgical procedures
Arm Title
preoperative relaxation program+preoperative surgery education
Arm Type
Experimental
Arm Description
preoperative relaxation program AND single education unit
Intervention Type
Behavioral
Intervention Name(s)
relaxation program
Intervention Description
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
1 week program, one introductory session and daily home practice
Intervention Type
Behavioral
Intervention Name(s)
surgery education
Intervention Description
intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery
1 single unit in the week before the surgery
Primary Outcome Measure Information:
Title
preoperative anxiety
Description
State Anxiety (STAI-S) (Spielberger 1970)
Time Frame
day of surgery
Title
postoperative pain intensity
Description
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
Time Frame
day after the surgery, before meditation
Secondary Outcome Measure Information:
Title
preoperative anxiety
Description
Trait Anxiety (STAI-T) (Spielberger 1970)
Time Frame
day of surgery
Title
preoperative anxiety
Description
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
Time Frame
day of surgery
Title
preoperative anxiety
Description
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
Time Frame
day of surgery
Title
postoperative disability
Description
interference of pain with movement, coughing, waking up at night and disturbed mood
Time Frame
day after surgery
Title
postoperative disability
Description
interference of pain with movement, coughing, waking up at night and disturbed mood
Time Frame
2 days after surgery
Title
postoperative disability
Description
interference of pain with movement, coughing, waking up at night and disturbed mood
Time Frame
10 days after surgery
Title
postoperative fatigue
Description
Fatigue measured by 0-10 Numeric Rating Scale
Time Frame
Day after surgery
Title
postoperative fatigue
Description
Fatigue measured by 0-10 Numeric Rating Scale
Time Frame
2 days after surgery
Title
postoperative fatigue
Description
Fatigue measured by 0-10 Numeric Rating Scale
Time Frame
10 days after surgery
Title
postoperative nausea
Description
Nausea measured by 0-10 Numeric Rating Scale
Time Frame
Day after surgery
Title
postoperative nausea
Description
Nausea measured by 0-10 Numeric Rating Scale
Time Frame
2 days after surgery
Title
postoperative nausea
Description
Nausea measured by 0-10 Numeric Rating Scale
Time Frame
10 days after surgery
Title
postoperative complications
Description
postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever
Time Frame
10 days after surgery
Title
Satisfaction with care
Description
Satisfaction with the operation, the hospital care
Time Frame
10 days after surgery
Title
Satisfaction with interventions
Description
Satisfaction with the interventions
Time Frame
10 days after surgery
Other Pre-specified Outcome Measures:
Title
course of surgery
Description
blood pressure, use of medication during operation, amount of gases during insufflation
Time Frame
day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustav Dobos, Prof, MD
Phone
+49201174
Ext
25001
Email
g.dobos@kliniken-essen-mitte.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof, MD
Organizational Affiliation
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen
City
Duisburg
ZIP/Postal Code
47228
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Omlor, Prof, MD
Phone
+49206597
Ext
1201
Email
chirurgie1@johanniter-rheinhausen.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
10829320
Citation
Omlor G, Kiewitz S, Pietschmann S, Roesler S. [Effect of preoperative preoperative visualization therapy on postoperative outcome after inguinal hernia surgery and thyroid resection]. Zentralbl Chir. 2000;125(4):380-5; discussion 385-6. German.
Results Reference
background
Learn more about this trial
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy
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