Mastectomy; LymphedemaNCT05914415
The Effect of Preoperative Education on Postoperative Healing Quality in Patients With Mastectomy
A study testing Supportive care and education before surgery in people with Mastectomy; Lymphedema and Breast Cancer, run by Saglik Bilimleri Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastectomy; Lymphedema, Breast Cancer
- What is being tested?
- Supportive care and education before surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mastectomy; Lymphedema, Breast Cancer
- Being tested
- Supportive care and education before surgery
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive care and education before surgeryOther
we will give supportive and informative education before surgery in order to increase patient' recovery rates
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | standard preoperative training Receives: Other: Supportive care and education before surgery |
| Experimental | Experimental | structured training app Receives: Other: Supportive care and education before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery rate
The quality of recovery of patients given structured education
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914415
- Sponsor's protocol ID
- EH2023SBU
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Structured Education Given to Patients Undergoing Mastectomy Surgery on the Quality of Post-operative Recovery
- ClinicalTrials.gov ID
- NCT05914415
- Acronym / sponsor ID
- EH2023SBU
- Conditions
- Mastectomy; Lymphedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Supportive care and education before surgerystandard preoperative training |
| Experimental | Experimental | Other: Supportive care and education before surgerystructured training app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a mastectomy operation
- At least primary school graduate
- No psychiatric illness
- No communication problems
- Willingness to participate in the research
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive care and education before surgerywe will give supportive and informative education before surgery in order to increase patient' recovery rates | Other | Control, Experimental |
Primary outcome
quality of recovery rate
Time frame: 6 months
The quality of recovery of patients given structured education
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care and education before surgery in people with Mastectomy; Lymphedema and Breast Cancer, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of recovery rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.