Completed

Pristina2/TRSelf-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography

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What is being tested

Self compression arm

Other
Who is being recruted

Breast Diseases+7

+ Breast Neoplasms

+ Neoplasms

Over 18 Months
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: January 2018
See protocol details

Summary

Principal SponsorAzienda USL Reggio Emilia - IRCCS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 25, 2018

Actual date on which the first participant was enrolled.

Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this allows to reduce the thickness of the breast thus improving the quality of the diagnostic image and reducing the dose of radiation necessary to obtain a clear image. Many women perceive as painful this compression, including women who have been treated for breast cancer. 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.

Official TitleSelf-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography
NCT04009278
Principal SponsorAzienda USL Reggio Emilia - IRCCS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

502 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteNeurologic ManifestationsPainSigns and SymptomsSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Criteria

4 inclusion criteria required to participate
Women in follow-up after surgery

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

4 exclusion criteria prevent from participating
Augmentation prostheses

Women in screening with active invitation

Physical impossibility to use the self-compression command

Inability to provide consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Laura Canovi

Reggio Emilia, ItalyOpen Laura Canovi in Google Maps
CompletedOne Study Center
Pristina2/TR | Self-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography | PatLynk