Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery

Not Applicable

Terminated

• Conditions: Gastrointestinal Diseases
• Interventions: Behavioral: relaxation program; Behavioral: surgery education

• Registration Number: NCT02541357
• 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 colorectal surgery.

Detailed Description

A former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. However the intervention was biased by concurrent pre-surgery education. Therefore 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 colorectal surgery using a factorial design.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• referral for colorectal surgery
• 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
• known malignoma
• severe comorbidity
• severe psychological disorders
• immunosuppression
• coagulation disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
postoperative nausea	10 days after surgery	Nausea measured by 0-10 Numeric Rating Scale
postoperative disability	10 days after surgery	interference of pain with movement, coughing, waking up at night and disturbed mood
preoperative anxiety	day of surgery	Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
postoperative fatigue	10 days after surgery	Fatigue measured by 0-10 Numeric Rating Scale
postoperative complications	10 days after surgery	Number of Participants With Treatment-Related Adverse Events
Satisfaction with care	10 days after surgery	Satisfaction with the operation, the hospital care on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)
Satisfaction with interventions	10 days after surgery	Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)

Trial Locations

Locations (1)

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