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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 colorectal surgery.
A former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. However the intervention was biased by concurrent pre-surgery education. Therefore 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 colorectal surgery using a factorial design.
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| 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 |
|
| preop relaxation and 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Duisburg | 47228 | Germany |
Study has been terminated
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| 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 | Number of Participants With Treatment-Related Adverse Events | 10 days after surgery |
| Satisfaction with care | Satisfaction with the operation, the hospital care on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied) | 10 days after surgery |
| Satisfaction with interventions | Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied) | 10 days after surgery |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |