Viewing Study NCT05830461



Ignite Creation Date: 2024-05-06 @ 6:55 PM
Last Modification Date: 2024-10-26 @ 2:57 PM
Study NCT ID: NCT05830461
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-07-03
First Post: 2023-03-21

Brief Title: Online Psychological Care Program for Women Who Attend a Breast Clinic
Sponsor: University of Guadalajara
Organization: University of Guadalajara

Study Overview

Official Title: Online Psychological Care Program to Reduce Psychological Distress in the Process of Diagnostic Evaluation andor Screening of Mammary Glands in Women Who Attend a Breast Clinic
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The objective of this study is to evaluate the effectiveness of an online psychological care program to reduce anxiety depression and negative psychological consequences and to increase a sense of coherence in the process of diagnostic evaluation andor screening of mammary glands in women who attend a breast clinic

There will be an experimental group and a control group The experimental group will receive the psychological intervention through a virtual platform and the control group will be given visual material with the information This platform will be designed based on the principles of user experience UX
Detailed Description: It has been shown that women who undergo diagnostic tests or screening of their mammary glands present symptoms associated with anxiety concerns regarding a possible positive result for malignancy as well as emotional distress It is important to generate psychological programs aimed at reducing the psychological consequences of the diagnostic evaluation andor screening of mammary glands because there are few approaches on the subject

In Mexico there are breast clinics of the Mexican Social Security Institute designed to perform screening tests and diagnostic evaluation of mammary glands with the aim of identifying cases of breast cancer in early stages However few psychological interventions have been reported during the diagnostic process so it is important to know the psychological affectations presented by women who undergo these tests Given this this intervention has the objective of evaluating the effectiveness of an online psychological care program to reduce psychological distress and increase the sense of coherence in the process of diagnostic evaluation of mammary glands in women who attend a breast clinic

In the intervention there will be two groups a experimental group and b control group

The experimental group will receive online psychological care through the virtual platform and the patients in the control group will be given visual material with the information

All participants will be invited to attend the breast clinic and undergo screening studies andor diagnostic evaluation For the assignment of the experimental and control group it will be carried out through a randomization process through the Excel program

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None