- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914415
The Effect of Preoperative Education on Postoperative Healing Quality in Patients With Mastectomy
June 13, 2023 updated by: Saglik Bilimleri Universitesi
The Effect of Preoperative Structured Education Given to Patients Undergoing Mastectomy Surgery on the Quality of Post-operative Recovery
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
standard preoperative training
|
we will give supportive and informative education before surgery in order to increase patient' recovery rates
|
Experimental: Experimental
structured training app
|
we will give supportive and informative education before surgery in order to increase patient' recovery rates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of recovery rate
Time Frame: 6 months
|
The quality of recovery of patients given structured education
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2023
Primary Completion (Estimated)
December 30, 2023
Study Completion (Estimated)
December 30, 2023
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
June 13, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH2023SBU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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