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

Primary Purpose

Gastrointestinal Diseases

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
relaxation program
surgery education
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Diseases focused on measuring Colorectal Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Usual care

preoperative relaxation program

preoperative surgery education

preop relaxation and surgery education

Arm Description

Does not receive a specific study intervention

preoperative relaxation program

single education unit to understand the complete surgical procedures

preoperative relaxation program AND single education unit

Outcomes

Primary Outcome Measures

preoperative anxiety
State Anxiety (STAI-S) (Spielberger 1970)
postoperative pain intensity
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

Secondary Outcome Measures

preoperative anxiety
Trait Anxiety (STAI-T) (Spielberger 1970)
preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
preoperative anxiety
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
postoperative complications
Number of Participants With Treatment-Related Adverse Events
Satisfaction with care
Satisfaction with the operation, the hospital care on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)
Satisfaction with interventions
Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)

Full Information

First Posted
September 1, 2015
Last Updated
May 23, 2017
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02541357
Brief Title
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery
Acronym
MBM_Colo
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment insufficient
Study Start Date
September 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
Keywords
Colorectal Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Does not receive a specific study intervention
Arm Title
preoperative relaxation program
Arm Type
Experimental
Arm Description
preoperative relaxation program
Arm Title
preoperative surgery education
Arm Type
Experimental
Arm Description
single education unit to understand the complete surgical procedures
Arm Title
preop relaxation and surgery education
Arm Type
Experimental
Arm Description
preoperative relaxation program AND single education unit
Intervention Type
Behavioral
Intervention Name(s)
relaxation program
Intervention Description
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice
Intervention Type
Behavioral
Intervention Name(s)
surgery education
Intervention Description
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
Primary Outcome Measure Information:
Title
preoperative anxiety
Description
State Anxiety (STAI-S) (Spielberger 1970)
Time Frame
day of surgery
Title
postoperative pain intensity
Description
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
Time Frame
day after the surgery, before meditation
Secondary Outcome Measure Information:
Title
preoperative anxiety
Description
Trait Anxiety (STAI-T) (Spielberger 1970)
Time Frame
day of surgery
Title
preoperative anxiety
Description
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
Time Frame
day of surgery
Title
preoperative anxiety
Description
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
Time Frame
day of surgery
Title
postoperative disability
Description
interference of pain with movement, coughing, waking up at night and disturbed mood
Time Frame
day after surgery
Title
postoperative disability
Description
interference of pain with movement, coughing, waking up at night and disturbed mood
Time Frame
2 days after surgery
Title
postoperative disability
Description
interference of pain with movement, coughing, waking up at night and disturbed mood
Time Frame
10 days after surgery
Title
postoperative fatigue
Description
Fatigue measured by 0-10 Numeric Rating Scale
Time Frame
day after surgery
Title
postoperative fatigue
Description
Fatigue measured by 0-10 Numeric Rating Scale
Time Frame
2 days after surgery
Title
postoperative fatigue
Description
Fatigue measured by 0-10 Numeric Rating Scale
Time Frame
10 days after surgery
Title
postoperative nausea
Description
Nausea measured by 0-10 Numeric Rating Scale
Time Frame
Day after surgery
Title
postoperative nausea
Description
Nausea measured by 0-10 Numeric Rating Scale
Time Frame
2 days after surgery
Title
postoperative nausea
Description
Nausea measured by 0-10 Numeric Rating Scale
Time Frame
10 days after surgery
Title
postoperative complications
Description
Number of Participants With Treatment-Related Adverse Events
Time Frame
10 days after surgery
Title
Satisfaction with care
Description
Satisfaction with the operation, the hospital care on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)
Time Frame
10 days after surgery
Title
Satisfaction with interventions
Description
Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)
Time Frame
10 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof, MD
Organizational Affiliation
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen
City
Duisburg
ZIP/Postal Code
47228
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study has been terminated

Learn more about this trial

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

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