Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
see above
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Does not receive a specific study intervention | |
| preoperative relaxation program | Experimental | preoperative relaxation program |
|
| preoperative surgery education | Experimental | single education unit to understand the complete surgical procedures |
|
| preoperative relaxation program+preoperative surgery education | Experimental | preoperative relaxation program AND single education unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relaxation program | Behavioral | relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice |
| Measure | Description | Time Frame |
|---|---|---|
| preoperative anxiety | State Anxiety (STAI-S) (Spielberger 1970) | day of surgery |
| postoperative pain intensity | numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving | day after the surgery, before meditation |
| Measure | Description | Time Frame |
|---|---|---|
| preoperative anxiety | Trait Anxiety (STAI-T) (Spielberger 1970) | day of surgery |
| preoperative anxiety | Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007) |
| Measure | Description | Time Frame |
|---|---|---|
| course of surgery | blood pressure, use of medication during operation, amount of gases during insufflation | day of surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustav Dobos, Prof, MD | Contact | +49201174 | 25001 | g.dobos@kliniken-essen-mitte.de |
| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof, MD | Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen | Recruiting | Duisburg | 47228 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10829320 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
Not provided
Not provided
| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| surgery education | Behavioral | 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 |
|
| day of surgery |
| preoperative anxiety | Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009) | day of surgery |
| postoperative disability | interference of pain with movement, coughing, waking up at night and disturbed mood | day after surgery |
| postoperative disability | interference of pain with movement, coughing, waking up at night and disturbed mood | 2 days after surgery |
| postoperative disability | interference of pain with movement, coughing, waking up at night and disturbed mood | 10 days after surgery |
| postoperative fatigue | Fatigue measured by 0-10 Numeric Rating Scale | Day after surgery |
| postoperative fatigue | Fatigue measured by 0-10 Numeric Rating Scale | 2 days after surgery |
| postoperative fatigue | Fatigue measured by 0-10 Numeric Rating Scale | 10 days after surgery |
| postoperative nausea | Nausea measured by 0-10 Numeric Rating Scale | Day after surgery |
| postoperative nausea | Nausea measured by 0-10 Numeric Rating Scale | 2 days after surgery |
| postoperative nausea | Nausea measured by 0-10 Numeric Rating Scale | 10 days after surgery |
| postoperative complications | postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever | 10 days after surgery |
| Satisfaction with care | Satisfaction with the operation, the hospital care | 10 days after surgery |
| Satisfaction with interventions | Satisfaction with the interventions | 10 days after surgery |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |