Trial document




drksid header

  DRKS00024663

Trial Description

start of 1:1-Block title

Title

Virtual reality-based meditation for enhancement of wellbeing, quality of life and patient satisfaction for in-patients undergoing chemotherapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This is a pilot study to investigate whether
1. Relaxation, breathing and meditation exercises in a virtual reality have an impact on the well-being and various aspects of the quality of life of patients with lung cancer who receive in-patient chemotherapy.
2. Relaxation, breathing and meditation exercises in a virtual reality have an impact on patient satisfaction in the hospital
3. Relaxation, breathing and meditation exercises in a virtual reality are accepted by lung cancer patients who receive chemotherapy and can be carried out in everyday hospital life
4. the study design used is suitable for a larger randomized study

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Pilot study to assess feasibility, patient acceptance and the magnitude of the effects of relaxation, breathing and meditation exercises in a virtual reality on well-being, patient satisfaction in the hospital and various aspects of quality of life in patients receiving in-patient chemotherapy for lung cancer

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

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

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00024663
  •   2021/02/26
  •   [---]*
  •   yes
  •   Approved
  •   20-905, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1254-9906 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C92.0 -  Acute myeloblastic leukaemia [AML]
  •   C91.0 -  Acute lymphoblastic leukaemia [ALL]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Virtual Reality Group:
    Each patient in the VR group will receive two different VR experiences in a daily changing VR environment every day from Monday to Friday. During the intervention patients will sit in a chair or in a hospital bed depending on patient condition and preference. The immersive VR experiences are meditative and designed to produce a calming effect. Despite the daily changing environment, the morning and evening sessions consist of recurring components that are part of every session. Two sessions are held each day (morning and evening). The exercises begin on the day of admission. The sessions are conducted until discharge. The morning VR experience lasts 7-8 minutes. The evening VR session is designed to produce a more calming effect and lasts 10 minutes but can be adjusted to last longer, if the patient desires. Before and after the intervention, heart rate, breathing rate and blood pressure are measured.
    All patients receive a questionnaire (EORTC QLQ-C30 with additional questions on the scales "Emotional functions", "Sleep" and "Fatigue") on the day of admission, on the 7th day and at discharge. 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") on the day of admission, on the 7th day and at discharge. Upon discharge, all patients receive an extended questionnaire with additional questions about patient satisfaction. All questions come from the EORTC CAT core item database.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome


Since this study is a feasibility study, it is not intended to test a specific hypothesis. We therefore distinguish between feasibility outcomes and clinical outcomes
Feasibility Endpoints:
- Participation, recruitment and retention rates. Participation rate is the proportion of participants providing consent of those who meet the inclusion criteria. Recruitment rate is the number of participants recruited per month. Retention rate is the number of participants who complete the full number of planned interventions.
- Intervention adherence. Adherence is the proportion of planned interventions that have been completed by each participant
- Patient compliance with completion of questionnaires. Compliance with completion of questionnaires is the proportion of completed questionnaires at the prespecified dates
- Adverse events. The frequency (number of participants and number of cases) and nature (e.g. dizziness, vertigo, motion sickness) and severity will be recorded.
- Deviations from study protocol. Number of deviations from study protocol (such as skipped interventions) and reason for deviation from study protocol (patient- related, staff-related, organisational).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Since this study is a feasibility study, it is not intended to test a specific hypothesis. We therefore distinguish between feasibility outcomes and clinical outcomes.
Clinical outcomes
- Change of mood and wellbeing before and after intervention.
- Change of vital signs such as heart rate, breathing rate, blood pressure before and after the intervention. Heart rate, breathing rate, blood pressure is measured manually before and after each intervention.
- Change in quality of life during the hospital stay. Quality of life is measured at predefined dates for each patient. Score and standard deviation in the quality of life questionnaire, as well as the score and standard deviation in all subscales, in particular emotional functioning, sleep, and fatigue are compared.
- Difference in quality of life between the two study groups. Score and standard deviation in the quality of life questionnaire are compared between both study groups.
- Difference in number and severity of side effects and complications from chemotherapy between the two study groups
- Difference in length of hospital stay between the two study groups
- Difference in patient satisfaction between the two study groups

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2021/05/20
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Adult patients capable of consent who are receiving inpatient chemotherapy for lung cancer.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Non-consenting patients; minor patients; pregnant patients; patients admitted as emergencies; patients participating in another intervention study that may have a potential impact on the endpoints of this study; Patients with infectious disease and need for isolation, pre-existing dementia, schizophrenia, hallucinations, panic attacks, or epileptic seizures; pacemaker or defibrillator wearers; patients taking neuroleptics or antiepileptic drugs; patients with active alcohol and/or drug abuse; lack of proficiency in German or English.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Augsburg
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Augsburg
    • Mr.  Dr.  Matthias  Schrempf 
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Augsburg
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Augsburg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Stenglinstrasse 2
    • 86156  Augsburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • TRIPP Inc.
    • Ms.  Nanea  Reeves 
    • 5877 Obama Blvd.
    • CA 90016  Los Angeles
    • United States
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.