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The Effect of Preoperative Education on Postoperative Healing Quality in Patients With Mastectomy

Primary Purpose

Mastectomy; Lymphedema, Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supportive care and education before surgery
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mastectomy; Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having a mastectomy operation At least primary school graduate No psychiatric illness No communication problems Willingness to participate in the research Complete the data collection forms Exclusion Criteria: Existence of a situation that prevents communication Unwillingness to participate in the research Incomplete answers to the questionnaire Individuals who are unwilling to continue the research will be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control

    Experimental

    Arm Description

    standard preoperative training

    structured training app

    Outcomes

    Primary Outcome Measures

    quality of recovery rate
    The quality of recovery of patients given structured education

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2022
    Last Updated
    June 13, 2023
    Sponsor
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05914415
    Brief Title
    The Effect of Preoperative Education on Postoperative Healing Quality in Patients With Mastectomy
    Official Title
    The Effect of Preoperative Structured Education Given to Patients Undergoing Mastectomy Surgery on the Quality of Post-operative Recovery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Breast cancer is one of the most common types of cancer today. Treatment is planned depending on various factors. The most common treatment option is surgery. Mastectomy is a type of surgery in which the entire breast is removed. Tumorous tissue is removed with mastectomy, and cancer is treated, but after the intervention, physiological, psychological and social problems may occur in individuals in the acute and chronic periods. By providing pre-operative education, complications in the postoperative period can be reduced and the patient's compliance with the treatment can be ensured. It is stated in the studies that the training given by the nurses with different methods before the surgery reduces the anxiety, pain level and increases the comfort of the patients. No study was found in which the preoperative structured education given to patients scheduled for mastectomy was evaluated with the Postoperative Healing Quality Scale. The study is planned to be conducted as a randomized controlled experimental study and the patients who applied to Bakırköy Dr.Sadi Konuk Training and Research Hospital General Surgery Clinic for mastectomy constitute the research population. The sample is planned to consist of 70 patients, including 35 control and 35 experimental groups. In the structured training program in the research, both face-to-face information will be given to the patients and a written training booklet will be used. Patient Diagnosis Form, Recovery Quality Scale will be used to collect data. Through the data obtained, it will be evaluated whether the education given to the patients who are planned for mastectomy has an effect on the quality of recovery in the early postoperative period. It is thought that this study will reveal the benefits of preoperative education, increase the health care satisfaction of the patients and support their recovery.
    Detailed Description
    Cancer is a disease caused by the uncontrolled proliferation of cells in a certain part of the body and the spread of these cells. Cancer, the incidence of which is increasing, affects the patient and his family physically, psychologically, socially and spiritually, and the symptoms experienced reduce the quality of life. Breast cancer is the most common cancer in women. Tumorous tissue is removed by mastectomy, one of the breast cancer treatment methods, but individuals are exposed to physiological, psychological and social problems. It has been revealed in the literature that the education given before surgery prepares patients for surgery, reduces anxiety, accelerates the treatment process, and reduces the use of analgesia. Özberksoy et al. (2009) stated that preoperative education given to breast cancer patients reduced their postoperative pain and anxiety levels.Yutmaz (2018) stated that the video-assisted training given before mastectomy reduced pain levels on the tenth postoperative day and increased comfort. Marize et al. (2018) found that as a result of the education applied to patients who were planned for breast cancer surgery, their anxiety levels decreased and their knowledge about treatment increased. Bozdemir (2021) states that the training given to women with breast cancer after surgery is effective in preventing lymphedema and increasing the quality of life. In our study, it is aimed to examine the effect of structured education to be given to patients who are planned for mastectomy on the quality of early postoperative recovery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mastectomy; Lymphedema, Breast Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    standard preoperative training
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    structured training app
    Intervention Type
    Other
    Intervention Name(s)
    Supportive care and education before surgery
    Intervention Description
    we will give supportive and informative education before surgery in order to increase patient' recovery rates
    Primary Outcome Measure Information:
    Title
    quality of recovery rate
    Description
    The quality of recovery of patients given structured education
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having a mastectomy operation At least primary school graduate No psychiatric illness No communication problems Willingness to participate in the research Complete the data collection forms Exclusion Criteria: Existence of a situation that prevents communication Unwillingness to participate in the research Incomplete answers to the questionnaire Individuals who are unwilling to continue the research will be excluded from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Preoperative Education on Postoperative Healing Quality in Patients With Mastectomy

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