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CompletedNCT01893944Updated Feb 19, 2014

Applicability of Video Games and Vibrational Therapy in Reducing Pain Secondary to Breast Cancer

An interventional study of virtual reality in Pain, sponsored by Universidade do Vale do Paraíba. Completed at 1 site in Brazil. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Universidade do Vale do Paraíba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study summary

To evaluate the influence of virtual reality and vibrational therapy in reducing pain intensity secondary to breast cancer before and after application of treatment protocols, through biomedical instrumentation.

Read the detailed description

After physiotherapy assessment individuals will be randomly divided into three groups: Group Virtual Reality - Cinesioterapia (G1), Group Vibration Therapy - Cinesioterapia (G2) and Control Group (G3), which will be submitted to the respective treatment protocols. Group Virtual Reality Cinesioterapia (G1) participate in this group 20 women will be treated through the games Xbox 360 ®, attributed to this, customized applications using virtual and augmented reality to be developed. Vibration Therapy Group - Cinesioterapia (G2) - will participate in this group 20 women who will undergo 15 minutes of continuous vibration through the blanket vibrating members higher, with frequency 40 Hz, 3 function and intensity tolerable, keeping the limb supported and elevated to 120 º. At the end held muscle stretching exercises, dissociation of shoulder girdle and upper limb exercises assets. Control group (G3) - participate in this group 20 women who are treated with conventional cinesioterapia through muscle stretching exercises for flexors, extensors, adductors and abductors shoulder for 20 seconds each; dissociation girdle; financial assets and Active assisted for groups flexors, extensors, abductors and adductors of the upper limbs, which will be performed three sets of 10 repetitions for each exercise. Implementation of treatment protocols for the groups G1, G2 and G3 will run for two weeks, being Monday through Friday feira.totalizando 10 consecutive treatment sessions lasting 30 minutes each session. You will be prompted to patients groups G1, G2 and G3 to respond individually and without any aid the visual numeric scale of pain, 10 minutes pre-therapy, 15 minutes after the start and 10 minutes after the end of therapy. Patients will undergo the assessment of pain, electromyographic activity of muscles, muscle strength, range of motion analysis and perimetry in the first day of treatment, and after completing all the sessions patients were reassessed.

02

Conditions studied

  • Pain

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Keywords

  • Breast cancer
  • vibratory therapy
  • virtual reality
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Universidade do Vale do Paraíba is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women who underwent surgery for unilateral mastectomy and axillary lymphadenectomy modified in a period exceeding one year;
  • Submit medical referral;
  • Which are not performing radiotherapy or chemotherapy;
  • Age 40-70 years;
  • Reporting pain, intermittent, prolonged duration and intensity that limits the ADL;
  • Lymphedema in the ipsilateral upper limb surgery;
  • To agree and sign the Statement of Consent

Exclusion criteria

Exclusion Criteria:

  • Individuals who fail to provide medical referral;
  • Be a carrier of other types of cancer;
  • Have undergone other types of surgery removal of breast cancer; - be doing chemotherapy or radiotherapy;
  • Do not complain of pain symptoms and lymphedema;
  • Presenting severe joint lock.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Virtual Reality

    - Participate in this group 20 women to be treated by means of games Xbox 360 ®, attributed to this, custom applications using virtual and augmented reality to be developed.

    Other: virtual reality

  • Experimental
    Vibration therapy

    - participate in this group 20 women who will undergo 15 minutes of continuous vibration by vibration of the upper mantle, with a frequency of 40 Hz, 3 function and intensity tolerable, keeping the limb supported and raised to 120 °.

    Other: virtual reality

  • Active comparator
    control group

    - participate in this group 20 women who are treated with conventional cinesioterapia through muscle stretching exercises, dissociation girdle, active and active-assisted exercises for groups flexors, extensors, abductors and adductors of the upper limbs, which will be three series 10 repetitions for each exercise.

    Other: virtual reality

Interventions

  • Othervirtual reality

    customized applications using virtual and augmented reality to be developed.

06

What researchers measure

Primary outcomes

  1. Pain secondary to breast cancer

    Expect positive results of this research on the reduction of pain as well as physical and functional complications caused by surgery for breast cancer, enabling a better quality of life for patients.

    Time frame: one year

07

Study locations

1 site
  • Lersm, Ip&D
    São José dos Campos, São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01893944
Lead sponsor
Universidade do Vale do Paraíba
Responsible party
Sponsor
First posted
Jul 9, 2013
Start date
Jan 2013
Primary completion
Mar 2013
Completion
Dec 2013
Last update
Feb 19, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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