An interventional study of relaxation program and surgery education in Gastrointestinal Diseases, sponsored by Universität Duisburg-Essen. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Prevention
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.
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.
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's enrollment of 4 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Universität Duisburg-Essen is the lead sponsor of 82 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Does not receive a specific study intervention
preoperative relaxation program
Behavioral: relaxation program
single education unit to understand the complete surgical procedures
Behavioral: surgery education
preoperative relaxation program AND single education unit
Behavioral: relaxation program · Behavioral: surgery education
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice
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
preoperative anxiety
State Anxiety (STAI-S) (Spielberger 1970)
Time frame: day of surgery
postoperative pain intensity
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
Time frame: day after the surgery, before meditation
preoperative anxiety
Trait Anxiety (STAI-T) (Spielberger 1970)
Time frame: day of surgery
preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
Time frame: day of surgery
preoperative anxiety
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
Time frame: day of surgery
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
Time frame: day after surgery
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
Time frame: 2 days after surgery
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
Time frame: 10 days after surgery
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
Time frame: day after surgery
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
Time frame: 2 days after surgery
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
Time frame: 10 days after surgery
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
Time frame: Day after surgery
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
Time frame: 2 days after surgery
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
Time frame: 10 days after surgery
postoperative complications
Number of Participants With Treatment-Related Adverse Events
Time frame: 10 days after surgery
Satisfaction with care
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
Satisfaction with interventions
Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)
Time frame: 10 days after surgery
Plan to share: No — Study has been terminated
No publications or documents are linked to this record.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Universität Duisburg-Essen