NCT07292727

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 6, 2025

Last Update Submit

December 6, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Assessment of pain intensity

    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

    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

Study Arms (2)

Traditional care group

ACTIVE COMPARATOR

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

Other: traditional care

Virtual reality group

EXPERIMENTAL

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 careOther: Virtual reality

Interventions

traditional careOTHER

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.

Traditional care groupVirtual reality group
Virtual realityOTHER

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.

Virtual reality group

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa Hassanin Shehata

Sohag, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ahmed Khalifa, Professor

    Sohag University

    STUDY DIRECTOR

  • Mohamed KhallafK, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hanaa H Shehata, Master

CONTACT

20 11 57332708hana.hassanin92@gmail.com

Doaa A Ali, PHD

CONTACT

01060267094doaa.atef@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 6, 2025

First Posted

December 18, 2025

Study Start

December 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 30, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

EG(1)