Breast CancerMastectomyNCT07596459
Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory of Women Undergoıng Mastectomy
A study testing Psychodynamic Nursing-Based Patient Education in people with Breast Cancer and Mastectomy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Our study aims to investigate the effects of planned hybrid (web-based and face-to-face) group training to be given to women with mastectomies based on Psychodynamic nursing theory, on women's body value, social appearance anxiety and sexual life quality. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Body Image
- What is being tested?
- Psychodynamic Nursing-Based Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2025to 15 Mar 2026
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-55, no communication problems,
- Proficiency in Turkish,
- Internet access via mobile phone or computer,
- At least 6 months must have passed since mastectomy surgery (mourning period),
- Active sexual life,
- Agreement to participate in the study.
Who cannot join
- Having hearing, vision, or comprehension problems,
- Having undergone breast reconstruction,
- Receiving any psychiatric diagnosis during the research process,
- Participating in any training, research, or social activity group that may affect the outcome variables during the research process.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technıcal Unıversity
Trabzon, Ortahisar, 61500
About this study
Official title: The Effect of Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory on Body Value, Socıal Appearance Anxıety and Sexual Qualıty of Lıfe of Women Undergoıng Mastectomy
Our study aims to investigate the effects of planned hybrid (web-based and face-to-face) group training to be given to women with mastectomies based on Psychodynamic nursing theory, on women's body value, social appearance anxiety and sexual life quality.
Power analysis was performed for the study group of the study and intervention and control groups were created by randomization method (intervention group n = 30, control group n = 30). The study will be applied as a pretest-posttest experimental intervention method. In order to make an evaluation before and after the planned hybrid training, the situations that are most affected by women after mastectomy were analyzed in line with the literature and the data were collected from the Sociodemographic Characteristics Form, Body Value Scale-2, Social Appearance Anxiety Scale (SAAS), Sexual Quality of Life Scale-Female (SQOL-W). will be collected using. A standard information brochure containing information about mastectomy will be given to the intervention and control groups after the pre-test. Then, hybrid group training based on Psychodynamic Nursing Theory will be given to the intervention group by the researcher. A Whatsapp group will also be established to enable patients to communicate and ask questions. During the process, 9 web-based and 3 face-to-face group trainings will be held. A posttest will be administered to both groups at the end of the last group training, and a permanence test will be administered 1 month later via Google surveys on the Whatsapp group. SPPS program and Pearson Chi-square test, Independent Samples Test, McNemar, Pearson Chi-square test, ANOVA (Repeated Measures ANOVA) will be used to analyze the data. As a result of the study, in line with the research findings, the effect of hybrid group training based on Psychodynamic Nursing Theory on the body value, social appearance anxiety and sexual life quality of women who have undergone mastectomy will be evaluated.
- Conditions
- Breast Cancer, Mastectomy, Body Image, Psychosocial Adjustment
- Being tested
- Psychodynamic Nursing-Based Patient Education
- Keywords
- nurse, mastectomy, Web-Based, Nursing Intervention, Psychosocial Support
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodynamic Nursing-Based Patient EducationBehavioural
The intervention group received hybrid group education sessions based on Psychodynamic Nursing Theory. A total of 12 sessions were conducted, including 9 web-based sessions and 3 face-to-face group sessions.
| Study group | Role | What they receive |
|---|---|---|
| initiative | Experimental | First, preliminary test data was collected. The researcher provided hybrid group training based on Psychodynamic Nursing Theory to the intervention group. Throughout the process, 9 web-based and 3 in-person group training sessions were conducted. A post-test was administered after the last group training session, and a retention test was administered one month later. Receives: Behavioral: Psychodynamic Nursing-Based Patient Education |
| control | No intervention | First, preliminary test data was collected. A standard information brochure was provided. Simultaneously with the intervention group, a post-test and retention test were administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Value Scale Score
Body esteem was assessed using the Body Esteem Scale (BES). Scores were compared between intervention and control groups.
Measured: 12 weeks
Social Appearance Anxiety Scale Score
Social appearance anxiety was measured using the Social Appearance Anxiety Scale (SAAS). Scores were compared between groups.
Measured: 12 weeks
Sexual Quality of Life Scale Score
Sexual quality of life was assessed using the Sexual Quality of Life-Female (SQOL-F) Scale. Scores were compared between groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start28 Nov 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Sari, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596459
- Sponsor's protocol ID
- E-13562490-050.01.04-562578
- Acronym
- Mastectomy
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect patient privacy, no private information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory on Body Value, Socıal Appearance Anxıety and Sexual Qualıty of Lıfe of Women Undergoıng Mastectomy
- ClinicalTrials.gov ID
- NCT07596459
- Acronym / sponsor ID
- Mastectomy / E-13562490-050.01.04-562578
- Conditions
- Breast Cancer, Mastectomy, Body Image, Psychosocial Adjustment
- Keywords
- nurse, mastectomy, Web-Based, Nursing Intervention, Psychosocial Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 19 May 2026 (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.
Our study aims to investigate the effects of planned hybrid (web-based and face-to-face) group training to be given to women with mastectomies based on Psychodynamic nursing theory, on women's body value, social appearance anxiety and sexual life quality.
Power analysis was performed for the study group of the study and intervention and control groups were created by randomization method (intervention group n = 30, control group n = 30). The study will be applied as a pretest-posttest experimental intervention method. In order to make an evaluation before and after the planned hybrid training, the situations that are most affected by women after mastectomy were analyzed in line with the literature and the data were collected from the Sociodemographic Characteristics Form, Body Value Scale-2, Social Appearance Anxiety Scale (SAAS), Sexual Quality of Life Scale-Female (SQOL-W). will be collected using. A standard information brochure containing information about mastectomy will be given to the intervention and control groups after the pre-test. Then, hybrid group training based on Psychodynamic Nursing Theory will be given to the intervention group by the researcher. A Whatsapp group will also be established to enable patients to communicate and ask questions. During the process, 9 web-based and 3 face-to-face group trainings will be held. A posttest will be administered to both groups at the end of the last group training, and a permanence test will be administered 1 month later via Google surveys on the Whatsapp group. SPPS program and Pearson Chi-square test, Independent Samples Test, McNemar, Pearson Chi-square test, ANOVA (Repeated Measures ANOVA) will be used to analyze the data. As a result of the study, in line with the research findings, the effect of hybrid group training based on Psychodynamic Nursing Theory on the body value, social appearance anxiety and sexual life quality of women who have undergone mastectomy will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| initiative | Experimental | Behavioral: Psychodynamic Nursing-Based Patient EducationFirst, preliminary test data was collected. The researcher provided hybrid group training based on Psychodynamic Nursing Theory to the intervention group. Throughout the process, 9 web-based and 3 in-person group training sessions were conducted. A post-test was administered after the last group training session, and a retention test was administered one month later. |
| control | No intervention | –First, preliminary test data was collected. A standard information brochure was provided. Simultaneously with the intervention group, a post-test and retention test were administered. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages 18-55, no communication problems,
- Proficiency in Turkish,
- Internet access via mobile phone or computer,
- At least 6 months must have passed since mastectomy surgery (mourning period),
- Active sexual life,
Key exclusion criteria (4 listed)
- Having hearing, vision, or comprehension problems,
- Having undergone breast reconstruction,
- Receiving any psychiatric diagnosis during the research process,
- Participating in any training, research, or social activity group that may affect the outcome variables during the research process.
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 |
|---|---|---|
| Psychodynamic Nursing-Based Patient EducationThe intervention group received hybrid group education sessions based on Psychodynamic Nursing Theory. A total of 12 sessions were conducted, including 9 web-based sessions and 3 face-to-face group sessions. | Behavioural | initiative |
Primary outcome
Body Value Scale Score
Time frame: 12 weeks
Body esteem was assessed using the Body Esteem Scale (BES). Scores were compared between intervention and control groups.
Social Appearance Anxiety Scale Score
Time frame: 12 weeks
Social appearance anxiety was measured using the Social Appearance Anxiety Scale (SAAS). Scores were compared between groups.
Sexual Quality of Life Scale Score
Time frame: 12 weeks
Sexual quality of life was assessed using the Sexual Quality of Life-Female (SQOL-F) Scale. Scores were compared between groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. In order to protect patient privacy, no private information will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychodynamic Nursing-Based Patient Education in people with Breast Cancer and Mastectomy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Value Scale Score (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 19 May 2026.