Effect of Virtual Reality on Pain and Anxiety During Chemotherapy Session in Breast Cancer Patients

Обзор

This study will be conducted to determine the effect of virtual reality exercise on pain and anxiety in breast cancer patients during chemotherapy treatment

Подробное описание

Many breast cancer survivors experience physical and psychological symptoms (such as pain, fatigue, depression, anxiety, and lymphedema); functional deficits (such as reduced shoulder range of motion and cognitive impairment); emotional problems (such as fatigue, pain, anxiety, and depression); and other complications such as bleeding, effusion, and flap necrosis. Side effects from breast cancer or treatment can have a significant impact on the quality of life (QoL) of breast cancer survivors.

Anxiety is present in about 10% of people during chemotherapy, while one-third of people with depression also show clinically significant anxiety states.

Pain occurs in 90% of patients treated with chemotherapy. Pain includes that produced by the neurotoxic action of antiblastic drugs, mechanical pressure of the tumor mass, metastases and pain in the phantom limb.

Over the last two decades, virtual reality (VR), has shown efficacy as a distraction tool to alleviate pain and distress during medical procedures. The need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of virtual reality on pain and anxiety in cancer patient during chemotherapy.

Вмешательства

• Другое traditional care
  Patients will take their prescribed medications from their physician and will continue their traditional activities during the intervention period, including reading, watching television, or visiting with guests.
• Другое Virtual reality
  The patients will receive their traditional care in addition to a fully immersive Head-Mounted Display virtual reality (Oculus meta Quest virtual reality (VR) headset with hand controller ) for 30 minutes, starting from the patient's second chemotherapy session and last for 3 sessions.

Первичные конечные точки

• Assessment of pain intensity [Срок оценки: 6 weeks]
• Assessment of anxiety [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Patients who are diagnosed with breast cancer.
• Patients who suffered from pain.
• Patient who suffered from anxiety.
• Patients who received chemo since 1cycle (session).
• Patients who received the same type of chemotherapy.
• Patients who are not suffer from anxiety disorders before chemotherapy.
• Patient who received chemotherapy for the first time in their treatment.

Критерии исключения

The potential participants will be excluded if they have one of the following criteria:

• injuries to the face or head
• Hand Injuries.
• Cognitive impairment
• A history of severe motion sickness
• Mental health problems.
• Visual and auditory problems.
• Radiotherapy
• A history of skull structure or cervical spine abnormalities that may complicate the use of VR devices.
• A history of epilepsy, seizures, vertigo.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Hanaa Hassanin Shehata — Sohag

Идентификаторы

NCT: NCT07292727 · P.T.REC/012/005460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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