The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography

Pain Clinical Trial

Official title:

Impact of Physical Exercise, Aimed at Reducing Pain in Women Who Underwent Mammography.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02215668
• Other study ID #: 313.907
• Status: Unknown status
• Phase: N/A
• First received: August 9, 2014
• Last updated: August 11, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: August 2014
• Source: University of Sao Paulo
• Contact: Altacilio A Nunes, Ph.D
• Phone: +551636022884
• Email: altacilio[@]fmrp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mammography is a systematic way in the main programs of screening for breast cancer in women over 40 or 50 years old, according to screening programs, but most research has shown a frequency of discomfort and pain during the examination mammography. This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination.

Description:

This research aims to evaluate the relationship of pre-mammography guided physical activity and pain after the examination, evaluating the impact of the intervention in a group of patients undergoing upper limb exercise (SLE), compared to another group women not subject exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination. The results will be checked by study association between the level of physical activity, body mass index, breast density and reducing the pain effect between groups for comparison of means and variances of values of the visual analogue scale (VAS).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 198
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 69 Years

Eligibility

Inclusion Criteria:

• Women: 20 to 69 years old

Exclusion Criteria:

• Cardiovascular disease

• Mental diseases

• Pulmonary diseases

• Steroids use

Related Conditions & MeSH terms

• Pain
• Side Effects

Intervention

Procedure:
• Physical exercise
Exercise muscle stretching and body warming.

Locations

Country	Name	City	State
Brazil	Hospital do Cancer de Barretos	Barretos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased pain after mammography.	Following the randomization, approximately 10 minutes after performing a physical exercise in the upper limbs (Group 1) and lower (Group 2), or not performing any physical exercise (Group 0), the woman will be submitted to bilateral mammogram. Ten minutes after the procedure, the assessment of pain during mammography will be measured by the visual analog scale. The mean difference between the measurements of visual analog scale (VAS) will be compared between groups.	Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.