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

Sponsor

Universität Duisburg-Essen (Other)

Overall Status

Terminated

CT.gov ID

NCT02541357

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Diseases	Behavioral: relaxation program Behavioral: surgery education	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

4 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 Colorectal Surgery - a Randomized Controlled Trial

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

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 program, 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: preop relaxation and 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 program, 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

Outcome Measures

Primary Outcome Measures

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

preoperative anxiety [day of surgery]
Trait Anxiety (STAI-T) (Spielberger 1970)
preoperative anxiety [day of surgery]
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
preoperative anxiety [day of surgery]
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
postoperative disability [day after surgery]
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative disability [2 days after surgery]
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative disability [10 days after surgery]
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative fatigue [day after surgery]
Fatigue measured by 0-10 Numeric Rating Scale
postoperative fatigue [2 days after surgery]
Fatigue measured by 0-10 Numeric Rating Scale
postoperative fatigue [10 days after surgery]
Fatigue measured by 0-10 Numeric Rating Scale
postoperative nausea [Day after surgery]
Nausea measured by 0-10 Numeric Rating Scale
postoperative nausea [2 days after surgery]
Nausea measured by 0-10 Numeric Rating Scale
postoperative nausea [10 days after surgery]
Nausea 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen	Duisburg		Germany	47228

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustav Dobos, Principle Investigator, Universität Duisburg-Essen

ClinicalTrials.gov Identifier:

NCT02541357

Other Study ID Numbers:

15-6459 MBM Colorectal

First Posted:

Sep 4, 2015

Last Update Posted:

May 25, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Gustav Dobos, Principle Investigator, Universität Duisburg-Essen

Colorectal Surgery

Additional relevant MeSH terms:

Gastrointestinal Diseases

Digestive System Diseases

Study Results

No Results Posted as of May 25, 2017