Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy (MBM_Galle)

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

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.

Study Overview

• Status: Unknown
• Conditions: Gall Stones
• Intervention / Treatment: Behavioral: relaxation program; Behavioral: surgery education

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Duisburg, Germany, 47228
    • Recruiting
    • Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Does not receive a specific study intervention
Experimental: 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
course of surgery	blood pressure, use of medication during operation, amount of gases during insufflation	day of surgery

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Gallstones
• Other Study ID Numbers: 14-6061-BO MBM_Galle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No