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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02476370
Other study ID # 14-6060-BO MBM_Hernio
Secondary ID
Status Recruiting
Phase N/A
First received June 16, 2015
Last updated May 23, 2017
Start date June 2015
Est. completion date June 2017

Study information

Verified date May 2017
Source Universität Duisburg-Essen
Contact Gustav Dobos, Prof, MD
Phone +49201174
Email g.dobos@kliniken-essen-mitte.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

see above


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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
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

Locations

Country Name City State
Germany Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen Duisburg

Sponsors (1)

Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other course of surgery blood pressure, use of medication during operation, amount of gases during insufflation day of surgery
Primary preoperative anxiety (State Anxiety (STAI-S) State Anxiety (STAI-S) (Spielberger 1970) day of surgery
Primary postoperative pain intensity (numeric rating scale) numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving day after the surgery, before medication
Secondary preoperative anxiety Trait Anxiety (STAI-T) (Spielberger 1970) day of surgery
Secondary preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS) Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007) day of surgery
Secondary preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009) day of surgery
Secondary postoperative disability interference of pain with movement, coughing, waking up at night and disturbed mood day after surgery
Secondary postoperative disability interference of pain with movement, coughing, waking up at night and disturbed mood 2 days after surgery
Secondary postoperative disability interference of pain with movement, coughing, waking up at night and disturbed mood 10 days after surgery
Secondary postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale Fatigue measured by 0-10 Numeric Rating Scale Day after surgery
Secondary postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale Fatigue measured by 0-10 Numeric Rating Scale 2 days after surgery
Secondary postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale Fatigue measured by 0-10 Numeric Rating Scale 10 days after surgery
Secondary postoperative nausea Nausea measured by 0-10 Numeric Rating Scale Nausea measured by 0-10 Numeric Rating Scale Day after surgery
Secondary postoperative nausea Nausea measured by 0-10 Numeric Rating Scale Nausea measured by 0-10 Numeric Rating Scale 2 days after surgery
Secondary postoperative nausea Nausea measured by 0-10 Numeric Rating Scale Nausea measured by 0-10 Numeric Rating Scale 10 days after surgery
Secondary postoperative complications postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeing, fever 10 days after surgery
Secondary Satisfaction with care Satisfaction with the operation, the hospital care 10 days after surgery
Secondary Satisfaction with interventions Satisfaction with the interventions 10 days after surgery
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