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

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ClinicalTrials.gov Identifier: NCT02481271
Recruitment Status : Unknown
Verified May 2017 by Gustav Dobos, Universität Duisburg-Essen.
Recruitment status was:  Recruiting
First Posted : June 25, 2015
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Gustav Dobos, Universität Duisburg-Essen

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
Gall Stones Behavioral: relaxation program Behavioral: surgery education Not Applicable

Detailed Description:
see above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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





Primary Outcome Measures :
  1. preoperative anxiety [ Time Frame: day of surgery ]
    State Anxiety (STAI-S) (Spielberger 1970)

  2. postoperative pain intensity [ Time Frame: day after the surgery, before meditation ]
    numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving


Secondary Outcome Measures :
  1. preoperative anxiety [ Time Frame: day of surgery ]
    Trait Anxiety (STAI-T) (Spielberger 1970)

  2. preoperative anxiety [ Time Frame: day of surgery ]
    Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)

  3. preoperative anxiety [ Time Frame: day of surgery ]
    Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)

  4. postoperative disability [ Time Frame: day after surgery ]
    interference of pain with movement, coughing, waking up at night and disturbed mood

  5. postoperative disability [ Time Frame: 2 days after surgery ]
    interference of pain with movement, coughing, waking up at night and disturbed mood

  6. postoperative disability [ Time Frame: 10 days after surgery ]
    interference of pain with movement, coughing, waking up at night and disturbed mood

  7. postoperative fatigue [ Time Frame: Day after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale

  8. postoperative fatigue [ Time Frame: 2 days after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale

  9. postoperative fatigue [ Time Frame: 10 days after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale

  10. postoperative nausea [ Time Frame: Day after surgery ]
    Nausea measured by 0-10 Numeric Rating Scale

  11. postoperative nausea [ Time Frame: 2 days after surgery ]
    Nausea measured by 0-10 Numeric Rating Scale

  12. postoperative nausea [ Time Frame: 10 days after surgery ]
    Nausea measured by 0-10 Numeric Rating Scale

  13. postoperative complications [ Time Frame: 10 days after surgery ]
    postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever

  14. Satisfaction with care [ Time Frame: 10 days after surgery ]
    Satisfaction with the operation, the hospital care

  15. Satisfaction with interventions [ Time Frame: 10 days after surgery ]
    Satisfaction with the interventions


Other Outcome Measures:
  1. course of surgery [ Time Frame: day of surgery ]
    blood pressure, use of medication during operation, amount of gases during insufflation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481271


Contacts
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Contact: Gustav Dobos, Prof, MD +49201174 ext 25001 g.dobos@kliniken-essen-mitte.de

Locations
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Germany
Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen Recruiting
Duisburg, Germany, 47228
Contact: Georg Omlor, Prof, MD    +49206597 ext 1201    chirurgie1@johanniter-rheinhausen.de   
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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Principal Investigator: Gustav Dobos, Prof, MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen

Publications:
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Responsible Party: Gustav Dobos, Principle Investigator, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02481271     History of Changes
Other Study ID Numbers: 14-6061-BO MBM_Galle
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Gustav Dobos, Universität Duisburg-Essen:
cholecystectomy

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical