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临床试验/NCT05861739
NCT05861739已完成不适用

The Effect of the Self-Care Support Program Applied to Women With Endometriosis on Quality of Life, Self-Care Behaviors, Depression, Anxiety and Stress Level

Marmara University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2024年5月16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
入组人数
65
试验地点
1
主要终点
Self-Care Behaviors Scale in Endometriosis

研究概览

简要总结

This study, was aimed to evaluate the effect of self-care support program (self-care training in endometriosis + motivational interview) applied to women with endometriosis on quality of life, self-care behaviors, depression, anxiety and stress levels.

详细描述

This study is a randomized controlled experimental study conducted to evaluate the effect of self-care support program applied to women with endometriosis on quality of life, self-care behaviors, depression, anxiety and stress levels.The research was carried out with the participation of two groups. Endometriosis Self-care Support program-ESSP (intervention group) will be applied to one of the groups, while the other group (control group) will receive standard treatment within the scope of the hospital protocol. Then, women's quality of life, self-care behaviors, depression, anxiety and stress levels will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Reproductive age (between 18-49 years old),
  • •Diagnosed with endometriosis (symptomatic patients),
  • •Having no medical or gynecological problems other than endometriosis,
  • •Literate,
  • •Mobile phone user,
  • •Non-pregnant,
  • •No communication barrier
  • •Not diagnosed with a psychiatric illness,
  • •Who volunteered to participate in the research,
  • •Women who can speak and understand Turkish will be included.

排除标准

  • •Who could not attend any session of ESSP (only in the intervention group),
  • •Filling the data collection forms incompletely,
  • •Pregnant at the time of the study and
  • •Women who have been hospitalized and/or had surgical operations for gynecological and medical reasons will be excluded.

研究组 & 干预措施

Intervention group

Experimental

Endometriosis Self Care Support Program (Endometriosis Training and Motivational Interview) will be applied to the women in the intervention group.

干预措施: Endometriosis Self-care Support Program (Behavioral)

Control group

No Intervention

Women in the control group will receive standard treatment. Training and motivational interviewing will not be applied.

结局指标

主要结局

Self-Care Behaviors Scale in Endometriosis

时间窗: Self-care behaviors will be evaluated at the first interview, 1st and 4th months. The change in the difference between the groups in terms of self-care behaviors over time will be evaluated.

This scale will be developed to measure the self-care behaviors of women with endometriosis.After the reliability and validity analyzes of the scale, the sub-dimensions of the scale, the number of items and the total score will be determined.

Endometriosis Health Profile

时间窗: Quality of life will be evaluated at the first interview, 1st and 4th months. The variation of the difference between the groups in terms of quality of life over time will be evaluated.

The Endometriosis Health Profile, consists of 11 questions. The lowest score that can be obtained from the entire questionnaire is 0 (best health condition), the highest score is 100 (worst health condition). The higher the score obtained from the questionnaire, the lower the quality of life.

Depression, Anxiety and Stress Scale

时间窗: Depression, anxiety and stress levels will be evaluated at the first interview, 1st and 4th months. The variation of the difference between the groups in terms of depression, anxiety and stress levels over time will be evaluated.

This scale, participants' depression, anxiety and stress levels will be evaluated.The scale consists of 21 items and 3 sub-dimensions (depression, anxiety and stress). There is a separate total score for each sub-dimension. As the score obtained from the subscale increases, the level of depression, anxiety and stress increases.

次要结局

  • Numerical Pain Scale(The pain level will be evaluated at the first interview, 1st and 4th months. The variation of the difference between the groups in terms of pain level over time will be evaluated.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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