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Not yet recruiting NCT07292727

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: traditional care, Virtual reality.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 30 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

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.

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • Assessment of pain intensity [Time frame: 6 weeks]
  • Assessment of anxiety [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Hanaa Hassanin Shehata — Sohag

Identifiers

NCT: NCT07292727 · P.T.REC/012/005460

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗