Gastrointestinal DiseasesMBM_ColoNCT02541357
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery
A study testing relaxation program and surgery education in people with Gastrointestinal Diseases, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- relaxation program and surgery education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Emergency surgery
- known malignoma
- severe comorbidity
- severe psychological disorders
- immunosuppression
- coagulation disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen
Duisburg, 47228
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Diseases
- Being tested
- relaxation program, surgery education
- Keywords
- Colorectal Surgery
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation programBehavioural
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
1 week program, one introductory session and daily home practice
surgery educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Does not receive a specific study intervention |
| preoperative relaxation program | Experimental | preoperative relaxation program Receives: Behavioral: relaxation program |
| preoperative surgery education | Experimental | single education unit to understand the complete surgical procedures Receives: Behavioral: surgery education |
| preop relaxation and surgery education | Experimental | preoperative relaxation program AND single education unit Receives: Behavioral: relaxation program; Behavioral: surgery education |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety
State Anxiety (STAI-S) (Spielberger 1970)
Measured: day of surgery
postoperative pain intensity
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
Measured: day after the surgery, before meditation
Secondary outcomes (15)
preoperative anxiety
Trait Anxiety (STAI-T) (Spielberger 1970)
Measured: day of surgery
preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)
Measured: day of surgery
preoperative anxiety
Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)
Measured: day of surgery
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
Measured: day after surgery
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
Measured: 2 days after surgery
postoperative disability
interference of pain with movement, coughing, waking up at night and disturbed mood
Measured: 10 days after surgery
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
Measured: day after surgery
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
Measured: 2 days after surgery
postoperative fatigue
Fatigue measured by 0-10 Numeric Rating Scale
Measured: 10 days after surgery
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
Measured: Day after surgery
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
Measured: 2 days after surgery
postoperative nausea
Nausea measured by 0-10 Numeric Rating Scale
Measured: 10 days after surgery
postoperative complications
Number of Participants With Treatment-Related Adverse Events
Measured: 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)
Measured: 10 days after surgery
Satisfaction with interventions
Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Recruitment insufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Dobos, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof, MD, Principal investigator, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541357
- Sponsor's protocol ID
- 15-6459 MBM Colorectal
- Acronym
- MBM_Colo
- Status last verified
- May 2017
- First submitted
- 1 Sep 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Study has been terminated
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02541357
- Acronym / sponsor ID
- MBM_Colo / 15-6459 MBM Colorectal
- Conditions
- Gastrointestinal Diseases
- Keywords
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment insufficient
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Does not receive a specific study intervention |
| preoperative relaxation program | Experimental | Behavioral: relaxation programpreoperative relaxation program |
| preoperative surgery education | Experimental | Behavioral: surgery educationsingle education unit to understand the complete surgical procedures |
| preop relaxation and surgery education | Experimental | Behavioral: relaxation program, Behavioral: surgery educationpreoperative relaxation program AND single education unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Emergency surgery
- known malignoma
- severe comorbidity
- severe psychological disorders
- immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation programrelaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice | Behavioural | preop relaxation and surgery education, preoperative relaxation program |
| surgery educationintensified 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 | Behavioural | preop relaxation and surgery education, preoperative surgery education |
Primary outcome
preoperative anxiety
Time frame: day of surgery
State Anxiety (STAI-S) (Spielberger 1970)
postoperative pain intensity
Time frame: day after the surgery, before meditation
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
15 secondary outcomes
preoperative anxiety
Time frame: day of surgery
preoperative anxiety
Time frame: day of surgery
preoperative anxiety
Time frame: day of surgery
postoperative disability
Time frame: day after surgery
postoperative disability
Time frame: 2 days after surgery
postoperative disability
Time frame: 10 days after surgery
postoperative fatigue
Time frame: day after surgery
postoperative fatigue
Time frame: 2 days after surgery
postoperative fatigue
Time frame: 10 days after surgery
postoperative nausea
Time frame: Day after surgery
postoperative nausea
Time frame: 2 days after surgery
postoperative nausea
Time frame: 10 days after surgery
postoperative complications
Time frame: 10 days after surgery
Satisfaction with care
Time frame: 10 days after surgery
Satisfaction with interventions
Time frame: 10 days after surgery
Results and safety
The study was stopped early (reason given: Recruitment insufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Individual participant dataSharing planned: No. Study has been terminated
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, Prof, MD principal investigator
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation program and surgery education in people with Gastrointestinal Diseases, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment insufficient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.