AnxietyNCT04381104
Strategy to Cope Pain and Discomfort in Mammography
A study testing Paracetamol in people with Anxiety and Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Anxiety, Pain, Discomfort
- What is being tested?
- Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 632 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Nov 2019to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All females patients aged above 40 years attending Dow Radiology Department for Mammographic Examination for the first time as screening or diagnostic purposes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow Institute of Radiology, Dow University of Health Sciences
Karachi, Sindh, 74200
Anila Rahim, 923002871530, dranilarahim@gmail.com
Amjad Sattar
About this study
Official title: Effective Strategy to Cope the Pain and Discomfort Among Women Undergoing Mammography
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.
Read the 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.
- Conditions
- Anxiety, Pain, Discomfort
- Being tested
- Paracetamol
- Keywords
- breast, mammography, paracetamol
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Panadol
The intervention arm will receive 2 capsules of paracetamols of 500mg.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Capsule Paracetamol 1000 mg 1 hour before the mammography procedure Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | The control arm will receive 2 capsules of placebo. Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour post medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start21 Nov 2019
- Primary completion14 Sep 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anila Rahim, Dow University of Health Sciences
- Investigators
- Anila Rahim, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381104
- Sponsor's protocol ID
- IRB-1391/DUHS/Approval/2019
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29595685Rahim 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.
PubMed 37680791
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Strategy to Cope the Pain and Discomfort Among Women Undergoing Mammography
- ClinicalTrials.gov ID
- NCT04381104
- Acronym / sponsor ID
- IRB-1391/DUHS/Approval/2019
- Conditions
- Anxiety, Pain, Discomfort
- Keywords
- breast, mammography, paracetamol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 14 Sep 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: ParacetamolCapsule Paracetamol 1000 mg 1 hour before the mammography procedure |
| Placebo | Placebo comparator | Drug: ParacetamolThe control arm will receive 2 capsules of placebo. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All females patients aged above 40 years attending Dow Radiology Department for Mammographic Examination for the first time as screening or diagnostic purposes
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: PanadolThe intervention arm will receive 2 capsules of paracetamols of 500mg. | Drug | Paracetamol, Placebo |
Primary outcome
Effectiveness of paracetamol before performing mammography in reducing pain and discomfort during mammography procedure
Time frame: 1 hour post medication
The pain score is being assessed via visual analogue scale (VAS) in the two groups, i.e. paracetamol and placebo, before performing mammography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Results publication: PubMed 29595685Freitas-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.
- Derived from this study: PubMed 37680791Rahim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anila Rahim principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Anxiety and Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed O Adil (923322319119, omair.adil@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of paracetamol before performing mammography in reducing pain and discomfort during mammography procedure (time frame: 1 hour post medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.