Effect of Distraction Technique on Pain and Anxiety During Mammography

NCT ID: NCT06682026

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-03-15

Brief 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. 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.

Conditions

Mammography Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

listening to music or chatting

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.

Group Type: EXPERIMENTAL

listening to music or chatting

Intervention Type: 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.

Interventions

listening to music or chatting

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hitit University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Yildirim

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Yıldırım Dr.

Role: CONTACT

fatmadmryldrm@gmail.com

05466742445

Other Identifiers

Hitit Uni Non-Interventional

Identifier Type: REGISTRY

Identifier Source: secondary_id

mammography

Identifier Type: -

Identifier Source: org_study_id