NCT07596459

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

April 23, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

nursemastectomyWeb-BasedNursing InterventionPsychosocial Support

Outcome Measures

Primary Outcomes (3)

  • Body Value Scale Score

    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

    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

    Sexual quality of life was assessed using the Sexual Quality of Life-Female (SQOL-F) Scale. Scores were compared between groups

    12 weeks

Study Arms (2)

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.

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.

Interventions

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.

initiative

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who have undergone mastectomy and have an active sexual life
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technıcal Unıversity

Trabzon, Ortahisar, 61500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
public health nursing doctoral student

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 19, 2026

Study Start

November 28, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

In order to protect patient privacy, no private information will be shared.

Locations