The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients

NCT06863623 | Recruiting DMC

• 2 other identifiers: KA-22070 (Hacettepe Un.)21-AKD-31
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platine-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. Some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy for supportive care. One of these methods is the virtual reality applications. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. In this study, the effect of interactive/imersive virtual reality intervention and relaxant video intervention on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients will be assigned to 3 groups: virtual reality intervention group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and dryg type. During the chemotherapy treatment, the patients will take interactive/immersibe virtual reality (VR group) or relaxant video application (RV group) consisting of nature-themed scenarios. The interventions will be done 2 times and about 20 minutes in the first day of each chemotherapy cycles, in total 2 cycles. The control group will receive routine nursing care. Research data will be collected at different intervals during the chemotherapy course with the Patient Information Form (only once), the Edmonton Symptom Diagnosis Scale, the NCCN Distress Thermometer, the European Cancer Treatment and Organization Committee Quality of Life Scale and the Patient Follow-up Form and will be analyzed with the IBM SPSS v.23 program.

Conditions

Lung Cancer; Chemotherapy Effect; Distress, Emotional; Quality of Life (QOL)

Keywords

cancer; chemotherapy; immersive; virtual reality; lung cancer; quality of life; symptom; side-effect

Outcome Measures

Primary Outcomes (1)

• Edmonton Symptom Assessment Scale (ESAS)

  Changes on overall score of Edmonton Symptom Assessment Scale. The scale is a numerical scale between 0 and 10 developed to measure each symptom level (total 12 symptoms). Lower scores indicate lower symptom levels.

  First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)

Secondary Outcomes (2)

• National Comprehensive Cancer Network Distress Thermometer (NCCN-DT)

  (Before and after the interventios/for control groups same time -20 mins.-) First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)

• The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-30)

  First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

Immersive Virtual Reality Group: Immersive virtual reality will be applied to this group 2 times during chemotherapy infusion (total of 2 chemotherapy cures) to reduce the symptom severity and distress level and improve the quality of life. For Immersive Virtual Reality interventions; The Meta Quest 2 device will be used and the virtual scenarios/contents were selected from "Nature Treks" app bought by the researcher. (Initially, a total of 6 VR contents and 6 similar videos were created for patients who received cisplatin+etoposide treatment consisting of three sessions of one chemotherapy cure (4 cure, 12 sessions). Due to the limited number of patients and regular attendance to treatment, other similar drug treatments were also included and finally, a total of 2 cures, 2 VR contents and 2 videos were selected and these 2 contents will be used.) These: 1. Walking in the Fores and Similar Video 2. Sitting on the Beaach and Similar Video

Other: İmmersive Virtaul Reality Applications

Relaxing Video Group

EXPERIMENTAL

Relaxing Video Group: Participants in this group will watch relaxing videos 2 times for 20 min during chemotherapy infusion (total of 2 chemotherapy cures) to reduce the symptom severity and distress level and improve the quality of life. The videos are slideshow-type videos consisting of various images and relaxing music prepared by the researcher. The videos were created by selecting images/sounds similar with the themes/scenarios in the virtual reality application. (Initially, a total of 6 VR contents and 6 similar videos were created for patients who received cisplatin+etoposide treatment consisting of three sessions of one chemotherapy cure (4 cure, 12 sessions). Due to the limited number of patients and regular attendance to treatment, other similar drug treatments were also included and finally, a total of 2 cures, 2 VR contents and 2 videos were selected and these 2 contents will be used.) These:Walking in the Fores and Similar Video Sitting on the Beaach and Similar Video

Other: Relaxing Videos

Control Group

NO INTERVENTION

Patients in the control group will receive standard nursing care applied in the chemotherapy unit. Standard nursing care; Training patients on the method of chemotherapy administration, its duration, content, side effects, and coping, preparing the drugs for administration, preparing the patients for treatment, starting the infusion, monitoring the patients during the infusion for side effects, infusion complications, changes in vital signs, etc. Includes applications.

Interventions

İmmersive Virtaul Reality Applications OTHER

To apply immersive virtual reality applications (Scenarios)

Virtual Reality Group

Relaxing Videos OTHER

To watch relaxing videos including pictures and sounds prepared by researcher

Relaxing Video Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are over 18 years old,
• diagnosed with lung cancer,
• will receive chemotherapy for the first time,
• will receive at least 2 cycles of chemotherapy treatment
• agree to participate in the study,

You may not qualify if:

• Having a cognitive and psychiatric disorder and diagnosis,
• Having brain metastasis or chronic disease related to the head-brain region,
• Having vision-hearing problems,
• Having epilepsy, vertigo, chronic severe headache, dizziness problems,
• Having a history of virtual reality, simulator or motion sickness,
• Having/declaring that he/she has open area, underwater, specific animal phobia,
• Do not agree to participate in the study

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kadir BAYSOY, PhD (c)

CONTACT

+905073045536; kadir.baysoy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assitant

Model Details: Three-Arm Randomised Controlled Trial

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: March 7, 2025
• Study Start: September 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)