Mammography ScreeningNCT06682026
Effect of Distraction Technique on Pain and Anxiety During Mammography
A study testing listening to music or chatting in people with Mammography Screening, run by Hitit University.
Trial summary
One of the non-medical interventions aimed at reducing sensitization is the cognitive-behavioral approach, in which the individual's attention is shifted from a painful stimulus to an external stimulus. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammography Screening
- What is being tested?
- listening to music or chatting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 40-69,
- Those without a benign tumor in their breasts,
- Those without any hearing-related health problems.
Who cannot join
- Women under 40 and over 69,
- Women with suspected breast cancer.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mammography and Distraction Technique
One of the non-medical interventions aimed at reducing sensitization is the cognitive-behavioral approach, in which the individual's attention is shifted from a painful stimulus to an external stimulus. This non-pharmacological approach can be adopted to alleviate stress and reduce cortisol concentrations in response to stress. There are a limited number of studies in the literature using distraction techniques during mammography. This study will examine the effects of distraction techniques on pain and anxiety during mammography.
Read the detailed description
According to global cancer statistics worldwide, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related death in women. Breast cancer is the most common cancer among women in Turkey (40.7%). Early diagnosis of breast cancer reduces the mortality rate. Mammography is one of the important diagnostic tools used in breast cancer screening. Mammography is the most suitable method for screening with its easily accessible features and is the most successful imaging method in early diagnosis. The American Cancer Society recommends mammography for women aged 40-44. Women aged 45-54 should have mammography every year for breast cancer risk. The National Turkish Guide recommends that screening should start at age 40 and end at age 69 and be applied every two years (Özkan et al., 2016). However, studies show that most women do not routinely undergo mammography. The most important factor preventing mammography in women is defined as pain. Compression of the breasts during mammography is a necessary procedure to reduce radiation dose and improve image quality. Most women report experiencing pain during this compression procedure. Breast tenderness before mammography, family history of breast cancer, high level of education, carelessness of healthcare personnel performing mammography, and previous pain experience with mammography increase the level of pain during mammography. Although there are some techniques to relieve pain today, it is still important to find easier methods to apply. One of the non-medical interventions aimed at reducing sensitivity is the cognitive-behavioral approach; with this approach, the individual's attention is shifted from a painful stimulus to an external stimulus. This non-pharmacological approach can be adopted to alleviate stress and lower cortisol concentrations in response to stress.
- Conditions
- Mammography Screening
- Being tested
- listening to music or chatting
- Keywords
- mammography, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
listening to music or chattingOther
Written consent will be obtained from the patients just before they enter the procedure, and Personal Information Forms and the State Anxiety Inventory (STAI) will be applied to all participants.
Women in the experimental group will be asked to listen to a lively music of their own choosing during the mammography, or for those who do not want music, their attention will be drawn in a different direction by chatting.
At the end of the procedure, the Visual Acuity Scale (VAS) pain scale and the State Anxiety Inventory (STAI) will be applied to both groups.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | Written informed consent will be obtained from the patients immediately before they enter the procedure, and Personal Information Forms and the State Anxiety Inventory (STAI) will be administered to all participants. No intervention will be made to women in the control group. At the end of the procedure, the Visual Analog Scale (VAS) pain scale and the State Anxiety Inventory (STAI) will be applied to both groups. |
| listening to music or chatting | Experimental | Written consent will be obtained from the patients just before they enter the procedure, and Personal Information Forms and the State Anxiety Inventory (STAI) will be applied to all participants.
Women in the experimental group will be asked to listen to a lively music of their own choosing during the mammography, or for those who do not want music, their attention will be drawn in a different direction by chatting.
At the end of the procedure, the Visual Acuity Scale (VAS) pain scale and the State Anxiety Inventory (STAI) will be applied to both groups. Receives: Other: listening to music or chatting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale (VAS) is one of the most commonly used instruments to subjectively measure various states such as pain and anxiety. It is a 10 cm ruler with 0 at one end indicating no pain or anxiety and 10 at the other end indicating the worst imaginable pain or anxiety. The scale was used to assess pain after examination in only 2 groups.
Measured: 5 minutes after the procedure
Secondary outcomes (1)
State Anxiety Inventory (STAI)
To measure state anxiety, which refers to how one feels at the moment, and trait anxiety, which refers to how one feels in general. The State Anxiety Inventory consists of 20 self-reported 4-point Likert-type items, with negatively worded items reverse scored. Total scores range from 20 to 80, with higher scores indicating increased levels of anxiety.
Measured: 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Dec 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammography ScreeningStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682026
- Sponsor's protocol ID
- mammography
- Other IDs
- Hitit Uni Non-Interventional
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mammography and Distraction Technique
- ClinicalTrials.gov ID
- NCT06682026
- Acronym / sponsor ID
- mammography
- Conditions
- Mammography Screening
- Keywords
- mammography, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
One of the non-medical interventions aimed at reducing sensitization is the cognitive-behavioral approach, in which the individual's attention is shifted from a painful stimulus to an external stimulus. This non-pharmacological approach can be adopted to alleviate stress and reduce cortisol concentrations in response to stress. There are a limited number of studies in the literature using distraction techniques during mammography. This study will examine the effects of distraction techniques on pain and anxiety during mammography.
Detailed description
According to global cancer statistics worldwide, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related death in women. Breast cancer is the most common cancer among women in Turkey (40.7%). Early diagnosis of breast cancer reduces the mortality rate. Mammography is one of the important diagnostic tools used in breast cancer screening. Mammography is the most suitable method for screening with its easily accessible features and is the most successful imaging method in early diagnosis. The American Cancer Society recommends mammography for women aged 40-44. Women aged 45-54 should have mammography every year for breast cancer risk. The National Turkish Guide recommends that screening should start at age 40 and end at age 69 and be applied every two years (Özkan et al., 2016). However, studies show that most women do not routinely undergo mammography. The most important factor preventing mammography in women is defined as pain. Compression of the breasts during mammography is a necessary procedure to reduce radiation dose and improve image quality. Most women report experiencing pain during this compression procedure. Breast tenderness before mammography, family history of breast cancer, high level of education, carelessness of healthcare personnel performing mammography, and previous pain experience with mammography increase the level of pain during mammography. Although there are some techniques to relieve pain today, it is still important to find easier methods to apply. One of the non-medical interventions aimed at reducing sensitivity is the cognitive-behavioral approach; with this approach, the individual's attention is shifted from a painful stimulus to an external stimulus. This non-pharmacological approach can be adopted to alleviate stress and lower cortisol concentrations in response to stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –Written informed consent will be obtained from the patients immediately before they enter the procedure, and Personal Information Forms and the State Anxiety Inventory (STAI) will be administered to all participants. No intervention will be made to women in the control group. At the end of the procedure, the Visual Analog Scale (VAS) pain scale and the State Anxiety Inventory (STAI) will be applied to both groups. |
| listening to music or chatting | Experimental | Other: listening to music or chattingWritten consent will be obtained from the patients just before they enter the procedure, and Personal Information Forms and the State Anxiety Inventory (STAI) will be applied to all participants. Women in the experimental group will be asked to listen to a lively music of their own choosing during the mammography, or for those who do not want music, their attention will be drawn in a different direction by chatting. At the end of the procedure, the Visual Acuity Scale (VAS) pain scale and the State Anxiety Inventory (STAI) will be applied to both groups. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 40-69,
- Those without a benign tumor in their breasts,
- Those without any hearing-related health problems.
Key exclusion criteria (2 listed)
- Women under 40 and over 69,
- Women with suspected breast cancer.
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 |
|---|---|---|
| listening to music or chattingWritten consent will be obtained from the patients just before they enter the procedure, and Personal Information Forms and the State Anxiety Inventory (STAI) will be applied to all participants. Women in the experimental group will be asked to listen to a lively music of their own choosing during the mammography, or for those who do not want music, their attention will be drawn in a different direction by chatting. At the end of the procedure, the Visual Acuity Scale (VAS) pain scale and the State Anxiety Inventory (STAI) will be applied to both groups. | Other | listening to music or chatting |
Primary outcome
Visual Analog Scale
Time frame: 5 minutes after the procedure
The Visual Analog Scale (VAS) is one of the most commonly used instruments to subjectively measure various states such as pain and anxiety. It is a 10 cm ruler with 0 at one end indicating no pain or anxiety and 10 at the other end indicating the worst imaginable pain or anxiety. The scale was used to assess pain after examination in only 2 groups.
1 secondary outcome
State Anxiety Inventory (STAI)
Time frame: 5 minutes after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing listening to music or chatting in people with Mammography Screening, run by Hitit University.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Yıldırım Dr. (05466742445, fatmadmryldrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 5 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.