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

NCT06863623 | Completed DMC

• 2 other identifiers: KA-22070 (Hacettepe Un.)21-AKD-31
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 3

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 Platinum-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 virtual reality. 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/immersive 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 drug type. During the chemotherapy treatment, the patients will take interactive/immersive 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 cycle, 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 Assessment Scale, the NCCN Distress Thermometer, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Patient Follow-up Form and will be analyzed with the IBM SPSS 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.

  Immediately before (T1, T3) and immediately after (T2, T4) each 20-minute intervention session across the first two chemotherapy cycles; same time points in the control group. 4 assessments in total.

Secondary Outcomes (2)

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

  Immediately before (T1, T3) and immediately after (T2, T4) each 20-minute intervention session across the first two chemotherapy cycles; same time points in the control group. 4 assessments in total.

• The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

  Before the first intervention session (T1) in the first chemotherapy cycle and after the final intervention session (T4) in the second cycle; same time points in the control group. 2 assessments in total.

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 Forest and Similar Video 2. Sitting on the Beach and Similar Video

Other: Immersive Virtual Reality

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 Forest and Similar Video,Sitting on the Beach 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

Relaxing Videos OTHER

To watch relaxing videos including pictures and sounds prepared by researcher

Relaxing Video Group

Immersive Virtual Reality OTHER

To apply immersive virtual reality (Virtual Environments)

Virtual Reality 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
• ECOG performance status of 2 or less

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 (3)

Hacettepe University Oncology Hospital

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Three-Arm Randomised Controlled Trial

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: March 7, 2025
• Study Start: January 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)