Clinical trial NCT05861739: The Effect of the Self-Care Support Program on Women with Endometriosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Quality of Life
Depression
Anxiety
Stress
Keywords: Endometriosis
Self-care support program
Quality of Life
Motivational interview
Self-care behaviors
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Self-Care Behaviors Scale in Endometriosis
timeFrame: 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.
measure: Endometriosis Health Profile
timeFrame: 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.
measure: Depression, Anxiety and Stress Scale
timeFrame: 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.
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Başıbüyük
Study officials:
affiliation: Marmara University
name: Nurdan Demirci, Prof.
role: STUDY_DIRECTOR
References: