MBM_Galle: Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
see above
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Usual care Does not receive a specific study intervention |
|
Experimental: preoperative relaxation program preoperative relaxation program |
Behavioral: relaxation program
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
1 week program, one introductory session and daily home practice
|
Experimental: preoperative surgery education single education unit to understand the complete surgical procedures |
Behavioral: surgery education
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
|
Experimental: preoperative relaxation program+preoperative surgery education preoperative relaxation program AND single education unit |
Behavioral: relaxation program
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
1 week program, one introductory session and daily home practice
Behavioral: surgery education
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
|
Outcome Measures
Primary Outcome Measures
- 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
- preoperative anxiety [day of surgery]
Trait Anxiety (STAI-T) (Spielberger 1970)
- preoperative anxiety [day of surgery]
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
- preoperative anxiety [day of surgery]
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
- postoperative disability [day after surgery]
interference of pain with movement, coughing, waking up at night and disturbed mood
- postoperative disability [2 days after surgery]
interference of pain with movement, coughing, waking up at night and disturbed mood
- postoperative disability [10 days after surgery]
interference of pain with movement, coughing, waking up at night and disturbed mood
- postoperative fatigue [Day after surgery]
Fatigue measured by 0-10 Numeric Rating Scale
- postoperative fatigue [2 days after surgery]
Fatigue measured by 0-10 Numeric Rating Scale
- postoperative fatigue [10 days after surgery]
Fatigue measured by 0-10 Numeric Rating Scale
- postoperative nausea [Day after surgery]
Nausea measured by 0-10 Numeric Rating Scale
- postoperative nausea [2 days after surgery]
Nausea 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
Other Outcome Measures
- course of surgery [day of surgery]
blood pressure, use of medication during operation, amount of gases during insufflation
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen | Duisburg | Germany | 47228 |
Sponsors and Collaborators
- Universität Duisburg-Essen
Investigators
- Principal Investigator: Gustav Dobos, Prof, MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
Study Documents (Full-Text)
None provided.More Information
Publications
- 14-6061-BO MBM_Galle