Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

Study Overview
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Brief Summary
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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 Cholecystectomy.

Detailed Description
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see above

Official Title
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Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial

Conditions
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Gall Stones

Intervention / Treatment
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* Behavioral: relaxation program
* Behavioral: surgery education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Does not receive a specific study intervention | |
| Experimental: preoperative relaxation program<br>preoperative relaxation program | Behavioral: relaxation program<br>* relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice<br>|
| Experimental: preoperative surgery education<br>single education unit to understand the complete surgical procedures | Behavioral: surgery education<br>* 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<br>|
| Experimental: preoperative relaxation program+preoperative surgery education<br>preoperative relaxation program AND single education unit | Behavioral: relaxation program<br>* relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice<br>Behavioral: surgery education<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy