肺がん患者に対する没入型の仮想現実とリラックスビデオの効果
化学療法を受けている肺がん患者の症状の重症度、苦痛、生活の質に対する没入型の仮想現実とリラックスビデオの効果
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.
調査の概要
詳細な説明
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. In addition to pharmacological approaches, some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy. One of these methods is the virtual reality application, which has started to be used in the field of health with the developing technology, allowing individuals to experience another reality where they are. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. It is stated that virtual reality intervention and audio-visual therapies (relaxant video application) have positive effects on cancer patients and patients receiving chemotherapy treatment. In this study, the effect of interactive/immersive virtual reality intervention and relaxant video application on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients diagnosed with lung cancer, receiving chemotherapy treatment for the first time, and whose protocols are Cisplatin+Etoposide, Carboplatin+Etoposide, Paclitaxel+Carboplatin, Docetaxel+Cisplatin, Cisplatin+Pemetrexed, Carboplatin+Pemetrexed, Cisplatin+Vinorelbine, Gemcitabine+Cisplatin/Carboplatin and only Cisplatin, will be included in the study. Patients will be assigned to 3 groups: virtual reality application 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, an interactive/immersive virtual reality intervention (VR group) and relaxant video intervention (RV group) consisting of nature-themed scenarios, which are preferred due to their relaxing effects, will be carried out for 2 times, about 20 minutes, the first day of each chemotherapy cycle, during 2 chemotherapy cycles. The control group will receive routine/standard nursing care. Research data will be collected at different intervals during the chemotherapy cures 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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Ankara、トルコ（Türkiye）
- Ankara Etlik City Hospital
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Ankara、トルコ（Türkiye）
- Ankara Bilkent City Hospital
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Ankara、トルコ（Türkiye）
- Hacettepe University Oncology Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Virtual Reality Group
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:
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To apply immersive virtual reality (Virtual Environments) |
|
実験的：Relaxing Video Group
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 |
To watch relaxing videos including pictures and sounds prepared by researcher |
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介入なし：Control Group
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Edmonton Symptom Assessment Scale (ESAS)
時間枠：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.
|
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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
National Comprehensive Cancer Network Distress Thermometer (NCCN-DT)
時間枠：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.
|
Changes on overall score of Distress Scale. The scale is a numerical scale between 0 and 10 developed to measure stress levels. Lower scores indicate lower stress 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.
|
|
The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
時間枠：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.
|
Changes on overall score of Quality of Life Scale. The scale is a multi-dimension scale including total 30 questions to measure quality of life level. Minimum score is 0, and maximum score is 100. |
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.
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KA-22070 (Hacettepe Un.)
- 21-AKD-31 (レジストリ識別子：Republic of Turkey Ministry of Health Turkish Medicines and Medical Devices Agency (TİTCK))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
It will be shared after the article published
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。