Strategy to Cope Pain and Discomfort in Mammography

NCT04381104 | Unknown DMC

• 1 other identifier: IRB-1391/DUHS/Approval/2019
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Discomfort

Keywords

breast; mammography; paracetamol

Outcome Measures

Primary Outcomes (1)

• Effectiveness of paracetamol before performing mammography in reducing pain and discomfort during mammography procedure

  The pain score is being assessed via visual analogue scale (VAS) in the two groups, i.e. paracetamol and placebo, before performing mammography

  1 hour post medication

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Capsule Paracetamol 1000 mg 1 hour before the mammography procedure

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

The control arm will receive 2 capsules of placebo.

Drug: Paracetamol

Interventions

Paracetamol DRUG

The intervention arm will receive 2 capsules of paracetamols of 500mg.

Also known as: Panadol

Paracetamol; Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow Institute of Radiology, Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 29595685 RESULT

• Rahim A, Rasheed B, Adil SO, Naz N, Aslam N. Effective strategy to cope the pain and discomfort among women undergoing mammography - A randomized controlled trial. Pak J Med Sci. 2023 Sep-Oct;39(5):1422-1428. doi: 10.12669/pjms.39.5.7500.

  PMID: 37680791 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anila Rahim

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed O Adil

CONTACT

923322319119; omair.adil@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The hospital pharmacy department is involved in the development of identical medicines both paracetamol and placebo. Codings are done by the hospital pharmacy department and researchers including principal investigator, care provider, outcome assessor, and even participant will remain blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anila Rahim

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: November 21, 2019
• Primary Completion: September 14, 2020
• Study Completion: November 20, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)