Effect of Distraction Technique on Pain and Anxiety During Mammography

NCT06682026 | Not Yet Recruiting

• 2 other identifiers: mammographyHitit Uni Non-Interventional
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mammography Screening

Keywords

mammography; pain; anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes after the procedure

Secondary Outcomes (1)

• State Anxiety Inventory (STAI)

  5 minutes after the procedure

Study Arms (2)

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.

Other: listening to music or chatting

Interventions

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.

listening to music or chatting

Eligibility Criteria

• Age: 40 Years - 69 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hitit University: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fatma Yıldırım Dr.

CONTACT

05466742445; fatmadmryldrm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: December 20, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 15, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share