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Effects of Preoperative Relaxation and Intensified Surgery Education in Patients Undergoing Herniotomy (MBM_Hernio)

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ClinicalTrials.gov Identifier: NCT02476370
Recruitment Status : Recruiting
First Posted : June 19, 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 Herniotomy.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Anxiety Postoperative Pain Behavioral: relaxation program Behavioral: surgery education Not Applicable

Detailed Description:
see above

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 Herniotomy - a Randomized Controlled Trial
Study Start Date : June 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 programm, 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 programm, 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 (State Anxiety (STAI-S) [ Time Frame: day of surgery ]
    State Anxiety (STAI-S) (Spielberger 1970)

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


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

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

  3. preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) [ 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 Fatigue measured by 0-10 Numeric Rating Scale [ Time Frame: Day after surgery ]
    Fatigue measured by 0-10 Numeric Rating Scale

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

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

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

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

  12. postoperative nausea Nausea measured by 0-10 Numeric Rating Scale [ 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, bleeing, 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



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

Inclusion Criteria:

  • referral for herniotomy
  • 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
  • recurrence of inaugural hernia
  • severe comorbidity
  • severy 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): NCT02476370


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

Locations
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
Principal Investigator: Gustav Dobos, Prof, MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen

Publications:
Responsible Party: Gustav Dobos, Principle Investigator, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02476370     History of Changes
Other Study ID Numbers: 14-6060-BO MBM_Hernio
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Pain, Postoperative
Hernia, Inguinal
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical