Clinical trial NCT04381104: Strategy to Cope Pain and Discomfort in Mammography
Official title: Effective Strategy to Cope the Pain and Discomfort Among Women Undergoing Mammography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Pain
Discomfort
Keywords: breast
mammography
paracetamol
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 632
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This will be a 2 arms individual randomized controlled trial. The intervention arm will receive 2 capsules of paracetamols of 500mg while the control arm will receive 2 capsules of placebo.
Primary purpose: DIAGNOSTIC

Brief summary: Most of the women complain about the pain and discomfort during the mammography procedure. It is reported in the literature that most of the time these pain and discomfort are due to anxiety-related causes. During counseling before mammography scan, it was also observed that most of the women had a general belief that mammography is a very painful procedure and they have a negative perception about mammography. Thus, the Majority of pain seems due to anxiety-related issues. Studies also support this evidence and it is reported in the literature that most of the women avoid mammography scans due to this negative perception which causes delay and ultimately a late diagnosis.

To validate the exact nature of pain and discomfort during mammography and to find out the strategy to cope with this anxiety-related pain and discomfort, there is a dire need for a study that can address this problem. Additionally, in our setup, most of the women who came for mammography are illiterate and belonged to the low socio-economic status. In these women, due to the negative perception, refusal or withdrawal rate is higher for mammography scans.

A thorough literature search has revealed studies on this issue are scarce both nationally and internationally. In the current study, Paracetamol will be used as a possible intervention which is the safest premedication for reducing pain while achieving standard compression which is necessary for good image quality. Thus, this study can help develop a strategy to control mammography discontinuation due to pain and discomfort.

Detailed description: Mammography is considered a fundamental part of diagnosis in modern health care services. It provides low dose soft tissue imaging of normal structure and pathology within the breast. A mammogram can be performed on both asymptomatic and symptomatic women with palpable lumps and any other complaints. It is an appropriate source of early detection for breast cancer in diagnostic imaging. This screening practice is associated with a strong reduction in mortality in breast cancer as many guidelines have already published. Thus, Mammography has been demonstrated as a "Gold Standard" technique used for Breast cancer Imaging.

Besides, a strong reliance on Mammographic examination that most of the females may experience breast pain and discomfort while achieving standard compression in mammography which is necessary for optimal image quality a number of trials have been published. Moreover, previously reported that anxiety-related psychological pain, false perception or fear of discomfort is a factual reason for pain and discomfort while performing mammography. Breast pain is also associated with the menstrual cycle and noncyclic (trauma, surgery, and infection). Although, pain, discomfort, anxiety and false beliefs is a major reason to discontinue this procedure and over the past decades taking part in mammography is quite challenging for many women.

Premeditated mammography with the aid of analgesics is one of the most suitable interventions for diminishing pain. In this current study, paracetamol is used as an intervention for diminishing pain during mammography. Previously, a study declared that paracetamol can reduce mild pain and most people can take this medicine safely. We planned this study to evaluate the effective strategy to cope with the pain and discomfort among women undergoing mammography.

Eligibility criteria: Inclusion Criteria:

* All females patients aged above 40 years attending Dow Radiology Department for Mammographic Examination for the first time as screening or diagnostic purposes

Exclusion Criteria:

* Patients in whom additional projections such as cone compression, magnification, axillary, cleavage projection, and extended views will be acquired.
* Post-operative cases
* Women already have painful tender breast lumps.
* Patient who are unable to cooperate with us to take medication (either placebo/paracetamol)
* Patient who haven't agreed to give informed consent
* Any prior history of Paracetamol reaction and toxicity
* Lactating mothers
* Females with the previous history of mammography exam

Primary outcomes:
measure: Effectiveness of paracetamol before performing mammography in reducing pain and discomfort during mammography procedure
timeFrame: 1 hour post medication
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow Institute of Radiology, Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Anila Rahim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freitas-Junior R, Martins E, Metran-Nascente C, Carvalho AA, Silva MFD, Soares LR, Ximenes CA. Double-blind placebo-controlled randomized clinical trial on the use of paracetamol for performing mammography. Medicine (Baltimore). 2018 Mar;97(13):e0261. doi: 10.1097/MD.0000000000010261.