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

December 6, 2025 updated by: Hanaa Hassanin Shehata Hassan, Cairo University
This study will be conducted to determine the effect of virtual reality exercise on pain and anxiety in breast cancer patients during chemotherapy treatment

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Hanaa Hassanin Shehata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional care group
This group includes patients suffering from pain and anxiety. Patients will receive their traditional care at every chemotherapy session
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.
Experimental: Virtual reality group
This group includes patients suffered from pain and anxiety. The patients received their traditional care in addition to a fully immersive Head-Mounted Display virtual reality.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed Khalifa, Professor, Sohag University
  • Study Chair: Mohamed KhallafK, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

December 6, 2025

First Submitted That Met QC Criteria

December 6, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 6, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005460

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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