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NCT Number: NCT06682026

Effect of Distraction Technique on Pain and Anxiety During Mammography

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.

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Key information

Conditions

Mammography Screening Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 40-69,
  • Those without a benign tumor in their breasts,
  • Those without any hearing-related health problems.

Exclusion criteria

  • Women under 40 and over 69,
  • Women with suspected breast cancer.

Treatment and study plan

listening to music or chatting

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. State Anxiety Inventory (STAI)

    Time frame: 5 minutes after the procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Yıldırım Dr.

CONTACT

[email protected]

05466742445

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

Mammography and Distraction Technique

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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