ClinicalTrials.gg
Status unknownNCT02476370MBM_HernioUpdated May 25, 2017

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

An interventional study of relaxation program and surgery education in Hernia, Inguinal, Anxiety and Postoperative Pain, sponsored by Universität Duisburg-Essen. Status unknown at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.

Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

see above

02

Conditions studied

  • Hernia, Inguinal
  • Anxiety
  • Postoperative Pain
03

In context

Hernia, Inguinal

561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.

This study's planned enrollment of 108 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Universität Duisburg-Essen is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Emergency surgery
  • malignoma
  • recurrence of inaugural hernia
  • severe comorbidity
  • severy psychological disorders
  • immunosuppression
  • coagulation disorders
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • No intervention
    Usual care

    Does not receive a specific study intervention

  • Experimental
    preoperative relaxation program

    preoperative relaxation program

    Behavioral: relaxation program

  • Experimental
    preoperative surgery education

    single education unit to understand the complete surgical procedures

    Behavioral: surgery education

  • Experimental
    preoperative relaxation program+preoperative surgery education

    preoperative relaxation program AND single education unit

    Behavioral: relaxation program · Behavioral: surgery education

Interventions

  • Behavioralrelaxation program

    relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week programm, one introductory session and daily home practice

  • Behavioralsurgery 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

06

What researchers measure

Primary outcomes

  1. preoperative anxiety (State Anxiety (STAI-S)

    State Anxiety (STAI-S) (Spielberger 1970)

    Time frame: day of surgery

  2. postoperative pain intensity (numeric rating scale)

    numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

    Time frame: day after the surgery, before medication

Secondary outcomes

  1. preoperative anxiety Trait Anxiety (STAI-T)

    (Spielberger 1970)

    Time frame: day of surgery

  2. preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)

    Time frame: day of surgery

  3. preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA)

    Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)

    Time frame: day of surgery

  4. postoperative disability

    interference of pain with movement, coughing, waking up at night and disturbed mood

    Time frame: day after surgery

  5. postoperative disability

    interference of pain with movement, coughing, waking up at night and disturbed mood

    Time frame: 2 days after surgery

  6. postoperative disability

    interference of pain with movement, coughing, waking up at night and disturbed mood

    Time frame: 10 days after surgery

  7. postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale

    Fatigue measured by 0-10 Numeric Rating Scale

    Time frame: Day after surgery

  8. postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale

    Fatigue measured by 0-10 Numeric Rating Scale

    Time frame: 2 days after surgery

  9. postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale

    Fatigue measured by 0-10 Numeric Rating Scale

    Time frame: 10 days after surgery

  10. postoperative nausea Nausea measured by 0-10 Numeric Rating Scale

    Nausea measured by 0-10 Numeric Rating Scale

    Time frame: Day after surgery

  11. postoperative nausea Nausea measured by 0-10 Numeric Rating Scale

    Nausea measured by 0-10 Numeric Rating Scale

    Time frame: 2 days after surgery

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

    Nausea measured by 0-10 Numeric Rating Scale

    Time frame: 10 days after surgery

  13. postoperative complications

    postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeing, fever

    Time frame: 10 days after surgery

  14. Satisfaction with care

    Satisfaction with the operation, the hospital care

    Time frame: 10 days after surgery

  15. Satisfaction with interventions

    Satisfaction with the interventions

    Time frame: 10 days after surgery

Other outcomes

  1. course of surgery

    blood pressure, use of medication during operation, amount of gases during insufflation

    Time frame: day of surgery

07

Study locations

1 of 1 sites recruiting
  • Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen
    Duisburg, 47228, Germany
    Recruiting
08

References and documents

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. PubMed 10829320 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02476370
Lead sponsor
Universität Duisburg-Essen
Responsible party
Gustav Dobos (Principle Investigator, Universität Duisburg-Essen) — Principal investigator
First posted
Jun 19, 2015
Start date
Jun 2015
Primary completion
Jun 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
May 25, 2017

Study contacts

Gustav Dobos, Prof, MD
Contact
g.dobos@kliniken-essen-mitte.de
+49201174 ext. 25001
Gustav Dobos, Prof, MD
principal investigator · Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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