Primary Objective: Primary Objective: 1. To investigate the effect of a VR modality as an education tool for patients undergoing oncological lung resection, compared to standard-of-care patient education in managing preoperative anxiety. 2. To…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Amsterdam Preoperative Anxiety and Information Scale (APAIS)
- Numeric Rating Scale (NRS) to assess pain
- Quality of Recovery-15 (QoR-15) questionnaire
- State-Trait Anxiety Inventory-6 (STAI-6) questionnaire
- Assessment of analgesic use in morphine milligram equivalents (MME), NSAID's
and Paracetamol
Secondary outcome
* The subjective experience of patients undergoing VR distraction therapy
* The heart rate variability of a patient undergoing VR distraction therapy as
a biometric proxy for pain relief & anxiety reduction.
* Length of Stay of patients in both groups
Background summary
Lung cancer is the leading cause of cancer death, with NSCLC being the most
common type. The 5-year survival rate for early-stage NSCLC is 65%, but drops
to 9% for advanced stages. Early-stage NSCLC is typically treated with surgery
or stereotactic body radiotherapy, while advanced cases require systemic
therapies like chemotherapy and immunotherapy. Post-operative pain and anxiety
are significant issues for patients, particularly in oncological lung surgery
due to the nature of the disease and the invasiveness of the procedures.
Traditional analgesics used for pain management have severe side effects,
highlighting the need for alternative treatments. VR modalities are emerging as
effective tools for patient education and non-pharmacological pain and anxiety
management. To explore this further, a randomized controlled trial will assess
the feasibility and efficacy of VR in post-operative pain and anxiety
management for oncological lung surgery patients.
Study objective
Primary Objective: Primary Objective: 1. To investigate the effect of a VR
modality as an education tool for patients undergoing oncological lung
resection, compared to standard-of-care patient education in managing
preoperative anxiety. 2. To investigate the effect of VR distraction therapy in
post-operative pain management in patients after oncological lung surgery
versus standard-of-care analgesia including morphine milligram equivalent
analgesia given to both groups. 3. To investigate the effect of VR distraction
therapy in pre- and post-operative anxiety management in patients after
oncological lung surgery versus the standard-of-care. Secondary Objective(s):
1. The subjective experience of patients undergoing VR distraction therapy 2.
The heart rate & heart rate variability (HRV) of a patient undergoing VR
distraction therapy as a biometric proxy for pain relief & anxiety reduction.
3. Ascertain which subgroups of patients may benefit most from a VR distraction
intervention 4. Impact of VR on length of stay
Study design
This study investigates two applications of virtual reality (VR) in patients
undergoing oncological lung surgery. The first application examines the impact
of VR-based patient education on anxiety levels. The second application
evaluates the effect of the LUVRE application, which is a relaxation tool. To
measure the possible effects of VR on anxiety and pain perception after
oncological lung surgery, a bi-center randomised controlled trial is being
conducted. The study will be performed at Leiden University Medical Center
(LUMC) and Amsterdam University Medical Center (location Vrije Universiteit
Medical Center). Both centers are part of one institution: Instituut voor Hart-
en Longchirurgie Nederland (IHLCN).
Intervention
The intervention consists of two components: a preoperative and a postoperative
phase. Preoperatively, patients receive additional information through a
virtual patient journey, where all steps from the outpatient clinic to
discharge are explained and shown via a virtual tour. Postoperatively, patients
use the LUVRE application, designed to serve as distraction therapy to
alleviate pain. Within the software, patients can select different calming
environments in which they wish to immerse themselves.
Preoperatively, patients will experience the virtual patient journey at the
outpatient clinic. The postoperative intervention schedule begins on Day 0
after surgery, with a single 20-minute session. From Day 1 post-surgery, the
intervention group will receive distraction therapy twice daily for 20 minutes
per session, continuing for 5 days after the operation. This is provided in
addition to the conventional pain management for lung cancer patients
undergoing VATS.
The placebo group receives no intervention, only the conventional pain
management for lung cancer patients undergoing VATS.
Study burden and risks
We do not foresee any risks or burdens incurred with participation, aside from
mild nausea which may occasionally occur during a virtual reality experience.
This typically subsides quickly once the head mounted display is removed. The
potential benefits of reducing post-operative pain and anxiety and shortening
post-surgical recovery time, outweigh these risks.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
• Patient*s age >=18 years
• Planned for oncological lung resection and visiting outpatient clinic
Exclusion criteria
• Hearing and/or visual impairments
• Psychiatric impairments
• Complaints of vomiting and nausea
• History of epilepsy
• Vestibulocochlear disorders including Meniere*s disease, Benign Paroxysmal
Positional Vertigo
• Claustrophobia
• Facial wounds and skin defects at site of application
• Patients placed in clinical isolation
• (Re)admission to the intensive care unit
• If planned surgery is not executed
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL87535.058.24 |