Study Results
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Basic Information
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COMPLETED
NA
502 participants
INTERVENTIONAL
2018-01-25
2020-12-31
Brief Summary
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Pain can discourage asymptomatic women to present themselves periodically to screening mammography, while an increasing number of women in follow-up after conservative surgery have to withstand the pain caused by mammography.
Some studies mention various factors that are responsible for pain when performing mammography: breast sensitivity, anxiety level, expected pain and staff attitude. Some studies have also identified breast density, breast volume and menstrual phase as other influencing factors, although not all studies support these hypothesis. The technical characteristics of the equipment can greatly affect annoyance, sense of oppression, pain. The technological proposals to reduce the discomfort of the patients concern various items: flexible compressors, self-compression devices under the supervision of the technician who performs the positioning and the minimum initial compression, environmental factors such as equipment noise reduction, chromatic, sound and sensory effects (eg: aromatic diffusers).
The aim of our study is to evaluate the effectiveness of the self-compression compared to the standard one, in reducing annoyance, a sense of oppression and pain, and to evaluate the difference of the average glandular dose given to the woman for each projection.
Self-compression may help reaching better compression tolerating the discomfort and pain induced thus allowing to achieve a lower thickness, a lower glandular dose and a better image.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
In the experimental arm the radiographer will first explain to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain.
SUPPORTIVE_CARE
SINGLE
The allocation to experimental or control arm ill be open to patients and the research staff.
The Image quality evaluations of Radiologists and the Radiographers are performed blindly.
Study Groups
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1. Self-compression arm
Intervention consist in a explanation by the radiographer to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain.
Self compression arm
The optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode.
2. Control arm
The mammography will be performed as normal clinical practice, with compression controlled by the radiographer.
No interventions assigned to this group
Interventions
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Self compression arm
The optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode.
Eligibility Criteria
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Inclusion Criteria
* Symptomatic women undergoing mammography
* Early diagnosis in asymptomatic women outside the organized screening program (these women are predominantly aged 40-44 / 75-85)
* Women with familiar risk
Exclusion Criteria
* Women in screening with active invitation
* Physical impossibility to use the self-compression command
* Inability to provide consent
18 Months
FEMALE
No
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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Principal Investigators
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Laura Canovi, RT
Role: PRINCIPAL_INVESTIGATOR
Arcispedale S.Maria Nuova
Locations
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Laura Canovi
Reggio Emilia, RE, Italy
Countries
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References
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Lau S, Abdul Aziz YF, Ng KH. Mammographic compression in Asian women. PLoS One. 2017 Apr 18;12(4):e0175781. doi: 10.1371/journal.pone.0175781. eCollection 2017.
Taplin SH, Rutter CM, Finder C, Mandelson MT, Houn F, White E. Screening mammography: clinical image quality and the risk of interval breast cancer. AJR Am J Roentgenol. 2002 Apr;178(4):797-803. doi: 10.2214/ajr.178.4.1780797.
Miller D, Livingstone V, Herbison P. Interventions for relieving the pain and discomfort of screening mammography. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002942. doi: 10.1002/14651858.CD002942.pub2.
Andrews FJ. Pain during mammography: implications for breast screening programmes. Australas Radiol. 2001 May;45(2):113-7. doi: 10.1046/j.1440-1673.2001.00889.x.
Poulos A, McLean D, Rickard M, Heard R. Breast compression in mammography: how much is enough? Australas Radiol. 2003 Jun;47(2):121-6. doi: 10.1046/j.0004-8461.2003.01139.x.
Mercer CE, Hogg P, Lawson R, Diffey J, Denton ER. Practitioner compression force variability in mammography: a preliminary study. Br J Radiol. 2013 Feb;86(1022):20110596. doi: 10.1259/bjr.20110596.
Mendat CC, Mislan D, Hession-Kunz L. Patient comfort from the technologist perspective: factors to consider in mammographic imaging. Int J Womens Health. 2017 May 18;9:359-364. doi: 10.2147/IJWH.S129817. eCollection 2017.
Davey B. Pain during mammography: possible risk factors and ways to alleviate pain. Radiography. 2007;13:5
de Groot JE, Branderhorst W, Grimbergen CA, den Heeten GJ, Broeders MJM. Towards personalized compression in mammography: a comparison study between pressure- and force-standardization. Eur J Radiol. 2015 Mar;84(3):384-391. doi: 10.1016/j.ejrad.2014.12.005. Epub 2014 Dec 13.
Feder K, Grunert JH. Is Individualizing Breast Compression during Mammography useful? - Investigations of pain indications during mammography relating to compression force and surface area of the compressed breast. Rofo. 2017 Jan;189(1):39-48. doi: 10.1055/s-0042-119450. Epub 2016 Dec 21.
Guidelines for Quality Assurance in Mammography Screening, third edition, The National Cancer Screening Service Board 2008
de Groot JE, Broeders MJ, Grimbergen CA, den Heeten GJ. Pain-preventing strategies in mammography: an observational study of simultaneously recorded pain and breast mechanics throughout the entire breast compression cycle. BMC Womens Health. 2015;15:26. doi: 10.1186/s12905-015-0185-2. Epub 2015 Mar 15.
Van Goethem M, Mortelmans D, Bruyninckx E, Verslegers I, Biltjes I, Van Hove E, De Schepper A. Influence of the radiographer on the pain felt during mammography. Eur Radiol. 2003 Oct;13(10):2384-9. doi: 10.1007/s00330-002-1686-6. Epub 2002 Nov 14.
Shrestha S, Poulos A, The effect of verbal information on the experience of discomfort in mammography, Radiography, Volume 7, Issue 4, Pages 271-277; 2001
Kornguth PJ, Keefe FJ, Wright KR, Delong DM. Mammography pain in women treated conservatively for breast cancer. J Pain. 2000 Winter;1(4):268-74. doi: 10.1054/jpai.2000.7884.
Iotti V, Giorgi Rossi P, Canovi L, Guberti M, Nitrosi A, Lippolis DG, Marchesi V, Besutti G, Ottone M, Vacondio R, Pattacini P; Self-Compression Reggio Emilia Working Group. Patient-centred care with self-compression mammography in clinical practice: a randomized trial compared to standard compression. Eur Radiol. 2023 Jan;33(1):450-460. doi: 10.1007/s00330-022-09002-z. Epub 2022 Jul 22.
Other Identifiers
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RCT Pristina 2/TR
Identifier Type: -
Identifier Source: org_study_id
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