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

Gastrointestinal Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02541357
• Other study ID #: 15-6459 MBM Colorectal
• Status: Terminated
• Phase: N/A
• First received: September 1, 2015
• Last updated: May 23, 2017
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• 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 colorectal surgery.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

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
• 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative anxiety	State Anxiety (STAI-S) (Spielberger 1970)	day of surgery
Primary	postoperative pain intensity	numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving	day after the surgery, before meditation
Secondary	preoperative anxiety	Trait Anxiety (STAI-T) (Spielberger 1970)	day of surgery
Secondary	preoperative anxiety	Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)	day of surgery
Secondary	preoperative anxiety	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	day after surgery
Secondary	postoperative fatigue	Fatigue measured by 0-10 Numeric Rating Scale	2 days after surgery
Secondary	postoperative fatigue	Fatigue measured by 0-10 Numeric Rating Scale	10 days after surgery
Secondary	postoperative nausea	Nausea measured by 0-10 Numeric Rating Scale	Day after surgery
Secondary	postoperative nausea	Nausea measured by 0-10 Numeric Rating Scale	2 days after surgery
Secondary	postoperative nausea	Nausea measured by 0-10 Numeric Rating Scale	10 days after surgery
Secondary	postoperative complications	Number of Participants With Treatment-Related Adverse Events	10 days after surgery
Secondary	Satisfaction with care	Satisfaction with the operation, the hospital care on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)	10 days after surgery
Secondary	Satisfaction with interventions	Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)	10 days after surgery