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

NCT ID: NCT07292727

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-03-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

traditional care

Intervention Type 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

Intervention Type 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.

Traditional care group

This group includes patients suffering from pain and anxiety. Patients will receive their traditional care at every chemotherapy session

Group Type ACTIVE_COMPARATOR

traditional care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hanaa Hassanin Shehata Hassan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Khalifa, Professor

Role: STUDY_DIRECTOR

Sohag University

Mohamed KhallafK, Professor

Role: STUDY_CHAIR

Cairo University

Locations

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Hanaa Hassanin Shehata

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hanaa H Shehata, Master

Role: CONTACT

Phone: 20 11 57332708

Email: [email protected]

Doaa A Ali, PHD

Role: CONTACT

Phone: 01060267094

Email: [email protected]

Other Identifiers

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P.T.REC/012/005460

Identifier Type: -

Identifier Source: org_study_id