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

NCT ID: NCT05914415

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mastectomy; Lymphedema Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

standard preoperative training

Group Type PLACEBO_COMPARATOR

Supportive care and education before surgery

Intervention Type OTHER

we will give supportive and informative education before surgery in order to increase patient' recovery rates

Experimental

structured training app

Group Type EXPERIMENTAL

Supportive care and education before surgery

Intervention Type OTHER

we will give supportive and informative education before surgery in order to increase patient' recovery rates

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supportive care and education before surgery

we will give supportive and informative education before surgery in order to increase patient' recovery rates

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EH2023SBU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.