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NCT Number: NCT07292727

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

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

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Key information

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hanaa Hassanin Shehata

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional care

Other

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.

Virtual Reality

Other

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 outcomes

  1. Assessment of pain intensity

    Time frame: 6 weeks

    Numerical rating scale (NRS) will be used to assess pain intensity. Pain levels will assess after the start of chemo infusion and immediately after intervention of VR for each session. The type of pain measured refers to any painful symptomatology that a cancer patient undergoing chemotherapy may experience. NRS score: "no pain = 0," "mild pain = 1-4," "moderate pain = 5-6," and "severe pain = 7-10."

  2. Assessment of anxiety

    Time frame: 6 weeks

    Hamilton anxiety scale (HAM-A) will be used to assess anxiety level. The HAM-A entails 14 items, each categorized by a series of symptoms, and measures mental agitation and psychological distress, as well as anxiety-related physical complaints. The responses on the scale were measured on a 5-point Likert scale: 0 (symptoms not present), 1 (mild symptoms), 2 (moderate symptoms), 3 (severe symptoms) and 4 (very severe symptoms). The total score was calculated by summation of the 14 items. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa A Ali, PHD

CONTACT

[email protected]

01060267094

Hanaa H Shehata, Master

CONTACT

[email protected]

20 11 57332708

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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