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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Breast Cancer

Treatments

Other: traditional care
Other: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT07292727
P.T.REC/012/005460

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

30 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Traditional care group
Active Comparator group
Description:
This group includes patients suffering from pain and anxiety. Patients will receive their traditional care at every chemotherapy session
Treatment:
Other: traditional care
Virtual reality group
Experimental group
Description:
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.
Treatment:
Other: Virtual reality
Other: traditional care

Trial contacts and locations

1

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Central trial contact

Hanaa H Shehata, Master; Doaa A Ali, PHD

Data sourced from clinicaltrials.gov

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