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

Not Applicable

• Conditions: Anxiety; Postoperative Pain; Hernia, Inguinal
• Interventions: Behavioral: surgery education; Behavioral: relaxation program

• Registration Number: NCT02476370
• Lead Sponsor: 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.

Detailed Description

see above

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
preoperative surgery education	surgery education	single education unit to understand the complete surgical procedures
preoperative relaxation program	relaxation program	preoperative relaxation program
preoperative relaxation program+preoperative surgery education	relaxation program	preoperative relaxation program AND single education unit
preoperative relaxation program+preoperative surgery education	surgery education	preoperative relaxation program AND single education unit

Primary Outcome Measures

Name	Time	Method
preoperative anxiety (State Anxiety (STAI-S)	day of surgery	State Anxiety (STAI-S) (Spielberger 1970)
postoperative pain intensity (numeric rating scale)	day after the surgery, before medication	numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

Secondary Outcome Measures

Name	Time	Method
preoperative anxiety Trait Anxiety (STAI-T)	day of surgery	(Spielberger 1970)
postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale	10 days after surgery	Fatigue measured by 0-10 Numeric Rating Scale
preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA)	day of surgery	Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
postoperative disability	10 days after surgery	interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative complications	10 days after surgery	postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeing, fever
preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS)	day of surgery	Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
postoperative nausea Nausea measured by 0-10 Numeric Rating Scale	10 days after surgery	Nausea measured by 0-10 Numeric Rating Scale
Satisfaction with care	10 days after surgery	Satisfaction with the operation, the hospital care
Satisfaction with interventions	10 days after surgery	Satisfaction with the interventions

Trial Locations

Locations (1)

Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen; 🇩🇪 Duisburg, Germany