Trial document




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  DRKS00020909

Trial Description

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Title

Virtual reality-based relaxation for enhancement of perioperative wellbeing and quality of life (VR-RELAX 1 Feasibility Trial)

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Trial Acronym

VR-RELAX 1

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URL of the Trial

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Brief Summary in Lay Language

This is a feasibility study to investigate whether

1. Relaxation, breathing and concentration exercises in a virtual reality have an impact on the well-being and various aspects of the quality of life of patients with colorectal cancer who have to undergo surgery.

2. Relaxation, breathing and concentration exercises in a virtual reality have an impact on perioperative patient satisfaction in the hospital

3. Relaxation, breathing and concentration exercises in a virtual reality are accepted by colon cancer patients who have to undergo surgery and can be carried out in everyday hospital life

4. the study design used is suitable for a larger randomized study

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Brief Summary in Scientific Language

Feasibility study to assess feasibility, patient acceptance and the magnitude of the effects of relaxation, breathing and concentration exercises in a virtual reality on perioperative well-being, patient satisfaction in the hospital and various aspects of quality of life for patients with colorectal cancer.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

This is a feasibility study that should serve as preliminary work for a possible randomized prospective study.

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Organizational Data

  •   DRKS00020909
  •   2020/03/02
  •   [---]*
  •   yes
  •   Approved
  •   19-915, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1242-6074 
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
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Interventions/Observational Groups

  •   Virtual Reality Group:
    Each patient in the VR group will receive two different VR relaxation exercises every day from Monday to Friday. Two sessions are held each day (morning and evening). The exercises begin on the day of admission in patients who are admitted before their surgery. For patients who are admitted on the day of surgery, a preoperative session only takes place if the patient is operated on in the afternoon of the admission day. The last session before the operation takes place on the evening before the operation for all patients who are operated on in the morning and in the morning on the day of the operation for all patients who are operated on in the afternoon. The first session after the operation takes place on the first postoperative day or as soon as the patient has been transferred from the intensive care unit to a normal ward. The sessions are held until discharge.
    In the morning session, relaxation and breathing exercises are performed in a soothing virtual environment, accompanied by soothing music. In addition, the patient receives easy-to-manage concentration exercises in the VR environment. These include, for example, controlling the flight of a simulated bird with head movements. The evening session consists of relaxation and breathing exercises without concentration exercises in a soothing VR environment accompanied by music. The sessions last 7-10 minutes. Pulse and blood pressure are measured before and after the intervention.
    All patients receive a questionnaire (EORTC QLQ-C30 with additional questions on the scales "Emotional functions", "Sleep" and "Fatigue") preoperatively and on the 7th postoperative day. Upon discharge, all patients receive an extended questionnaire with additional questions about patient satisfaction. All questions come from the EORTC CAT core item database. Before and after the intervention, patients receive a short questionnaire.
  •   Intervention: Music: In the music group, each participant is played soothing classical music for 7-10 minutes twice a day from Monday to Friday using headphones. The exercises begin on the day of admission in patients who are admitted before their surgery. For patients who are admitted on the day of surgery, a preoperative session only takes place if the patient is operated on in the afternoon of the admission day. The last session before the operation takes place on the evening before the operation for all patients who are operated on in the morning and in the morning on the day of the operation for all patients who are operated on in the afternoon. The first session after the operation takes place on the first postoperative day or as soon as the patient has been transferred from the intensive care unit to a normal ward. The sessions are held until discharge.
    Pulse and blood pressure are measured before and after the intervention.
    All patients receive a questionnaire (EORTC QLQ-C30 with additional questions on the scales "Emotional functions", "Sleep" and "Fatigue") preoperatively and on the 7th postoperative day. Upon discharge, all patients receive an extended questionnaire with additional questions about patient satisfaction. All questions come from the EORTC CAT core item database. Before and after the intervention, patients receive a short questionnaire.
  •   Control group: There is no intervention in the control group. All patients receive a questionnaire (EORTC QLQ-C30 with additional questions on the scales "Emotional functions", "Sleep" and "Fatigue") preoperatively and on the 7th postoperative day. Upon discharge, all patients receive an extended questionnaire with additional questions about patient satisfaction. All questions come from the EORTC CAT core item database.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Since this study is a feasibility study, it is not intended to test a specific hypothesis.

Primary endpoint: quality of life in the perioperative phase of patients with colorectal cancer or liver metastases from colorectal cancer.

Measured as:
Score and standard deviation in the QLQ-C30 quality of life questionnaire as well as score and standard deviation in all QLQ-C30 subscales, especially in the "emotional functions", "sleep" and "fatigue" scales in all 3 groups. The measured difference in outcome between the groups should enable a precise calculation of the number of cases for a future study.

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Secondary Outcome

1. Willingness to participate in the study in the study population examined
a. Measured as the proportion of patients who can be included in the study but refuse to participate

2. Proportion of patients who meet the inclusion criteria for the study
a. Measured as the proportion of patients with colorectal cancer or metastases from colorectal cancer who are unable to participate in the study due to the defined inclusion / exclusion criteria.

3. Review the suitability of the questionnaires used to measure wellbeing, quality of life and patient satisfaction.

4. Patient compliance regarding the intervention and filling out the questionnaires
a. Measured as the proportion of canceled VR meetings, proportion of complete or partially completed questionnaires

5. Feasibility of the study protocol
a. Measured as a percentage of planned and non-interventions and number of deviations from the study protocol

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/03/09
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Patients of who are of legal age and able to give consent undergoing surgery due to colorectal cancer or liver metastases from colorectal cancer

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Exclusion Criteria

Non-consentable patients; underage patients; pregnant patients; patients admitted as an emergency; patients participating in another clinical study that may have an impact on the endpoints of this study; previously known dementia, schizophrenia, hallucinations, panic attacks or epileptic seizures; patients with pacemakers or defibrillator devices; patients taking neuroleptics or antiepileptics; patients with active alcohol and / or drug abuse; lack of knowledge of German or English

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Addresses

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Augsburg
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Augsburg
    • Mr.  Dr.  Matthias  Schrempf 
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Augsburg
    • Mr.  Prof. Dr.  Matthias  Anthuber 
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Augsburg
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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