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临床试验/NCT06981910
NCT06981910已完成不适用

The Effect of Psychoeducation on Body Image and Sexual Quality of Life in Patients Undergoing Mastectomy

Dicle University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Breast Cancer Body Image Scale (BCBIS)

研究概览

简要总结

This study aims to examine the effect of psychoeducation on body image and sexual quality of life in female patients who underwent mastectomy due to breast cancer.

详细描述

Method: This randomized controlled trial with two parallel groups was conducted between October 2023 and January 2025 in the general surgery clinic of a university hospital. The sample consisted of 63 patients (31 in the psychoeducation group and 32 in the control group). Data collection was conducted using the Patient Information Form, the Breast Cancer Body Image Scale (BCBIS), and the Sexual Quality of Life-Female (SQoL-F) questionnaire. Following the pretest administered to all participants, patients in the psychoeducation group received a 6-week psychoeducation program (90 minutes per week). After the completion of the 6-week intervention, a 4-week waiting period was implemented, after which the posttest was administered to all participants. Data analysis included descriptive statistics, chi-square test, t-test, Kolmogorov-Smirnov test, Cronbach's alpha coefficient, ANOVA, and Bonferroni post hoc tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women aged between 18 and 60 years
  • •Married and/or with a partner,
  • •Residing in the city where this study was carried out,
  • •İnformed about their diagnosis,
  • •With no physical deformities or functional impairments caused by comorbid conditions or treatments (e.g., lymphedema, hemiparesis, amputation, tracheostomy),
  • •Capable of communication, no cognitive impairments or diagnosed psychiatric disorders,
  • •Having completed chemotherapy and/or radiotherapy,
  • •With no prior counseling or education related to body image or sexual quality of life.

排除标准

  • •xclusion Criteria:
  • •Women who were not between the ages of 18 and 60,
  • •Not married and/or without a partner,
  • •Not residing in the city where the study was conducted,
  • •Not informed about their diagnosis,
  • •With physical deformities or functional impairments caused by comorbid conditions or treatments (e.g., lymphedema, hemiparesis, amputation, tracheostomy),
  • •Unable to communicate, with cognitive impairments or diagnosed psychiatric disorders,
  • •Still undergoing chemotherapy and/or radiotherapy,
  • •Had previously received any counseling or education related to body image or sexual quality of life.

研究组 & 干预措施

Psychoeducation

Experimental

A semi-structured "Psychoeducation Program" was implemented over six weeks, with 90-minute sessions conducted weekly. Each subgroup received psychoeducation on different days within the same week. The week the psychoeducation concluded was designated as Week 0, and the scales were re-administered in Week 4.

干预措施: Psychoeducation program (Behavioral)

Control

No Intervention

No intervention was provided to the control group; the same scales were administered to them during the 4th week after the conclusion of the psychoeducation program in the psychoeducation group

结局指标

主要结局

Breast Cancer Body Image Scale (BCBIS)

时间窗: 12 weeks

The scale comprises 43 items (32 positively worded and 11 negatively worded) divided into two sections. Section 1 uses a five-point Likert scale: "Strongly disagree" (1), "Disagree" (2), "Neutral" (3), "Agree" (4), and "Strongly agree" (5). Section 2 also employs a five-point Likert scale: "Never" (1), "Rarely" (2), "Sometimes" (3), "Usually" (4), and "Always" (5). Negatively worded items are reverse-scored. The total score ranges between 43 and 215, and there is no established cutoff point; higher scores indicate a higher level of body image disturbance. The scale consists of six subdimensions. The Cronbach's α for the overall scale was reported to be 0.67.

Female Sexual Life Quality Scale (SQoL-F)

时间窗: 12 weeks

This 18-item scale has a six-point Likert format and was designed to be self-administered by women aged 18 and older. Participants are instructed to respond based on their sexual experiences during the past four weeks. Items are scored as follows: "Completely agree" (1), "Mostly agree" (2), "Somewhat agree" (3), "Somewhat disagree" (4), "Mostly disagree" (5), and "Completely disagree" (6). Before computing the total score (ranging from 18 to 108), responses to items 1, 5, 9, 13, and 18 are reverse-scored. The final score is converted to a scale out of 100, and a higher score indicates better sexual quality of life. The Cronbach's α for the overall scale is 0.83.

次要结局

未报告次要终点

研究者

发起方
Dicle University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Çiçek SARUHAN

Lecturer

Dicle University

研究点 (1)

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