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
About this trial
This is an interventional supportive care trial for Mastectomy; Lymphedema
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.
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
NCT ID
NCT05914415
First Posted
August 26, 2022
Last Updated
June 13, 2023
Sponsor
Saglik Bilimleri Universitesi
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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