- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596459
Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory of Women Undergoıng Mastectomy (Mastectomy)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ortahisar
-
Trabzon, Ortahisar, Turkey (Türkiye), 61500
- Karadeniz Technıcal Unıversity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: initiative
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.
|
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.
|
|
No Intervention: control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
|
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.
|
12 weeks
|
|
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
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-13562490-050.01.04-562578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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