Applicability of Video Games and Vibrational Therapy in Reducing Pain Secondary to Breast Cancer
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Jan 2013
1 active site
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
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 19, 2014
February 1, 2014
2 months
June 24, 2013
February 14, 2014
Conditions
Keywords
Outcome Measures
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.
one year
Study Arms (3)
Virtual Reality
EXPERIMENTAL\- 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.
Vibration therapy
EXPERIMENTAL\- 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 °.
control group
ACTIVE COMPARATOR\- 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.
Interventions
customized applications using virtual and augmented reality to be developed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lersm, Ip&D
São José dos Campos, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
July 9, 2013
Study Start
January 1, 2013
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
February 19, 2014
Record last verified: 2014-02