The Effect of the Self-Care Support Program on Women With Endometriosis

Study Overview
=================
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.

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

Conditions
-----------------
Endometriosis, Quality of Life, Depression, Anxiety, Stress

Intervention / Treatment
-----------------
* Behavioral: Endometriosis Self-care Support Program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Endometriosis Self Care Support Program (Endometriosis Training and Motivational Interview) will be applied to the women in the intervention group. | Behavioral: Endometriosis Self-care Support Program<br>* ESSP will be applied to the women in the intervention group in four sessions, one week apart. In the first and second sessions, a self-care training program will be applied. In the third and fourth sessions, motivational interview will be made by contacting the women by phone.<br>|
| No Intervention: Control group<br>Women in the control group will receive standard treatment. Training and motivational interviewing will not be applied. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Behaviors Scale in Endometriosis | 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. | 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. | 
| Endometriosis Health Profile | 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. | 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. | 
| Depression, Anxiety and Stress Scale | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Scale | It will be used to determine the pain levels of the participants.It starts with the absence of pain (0) on numerical scales and reaches the level of unbearable pain (10). | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Self-care support program, Quality of Life, Motivational interview, Self-care behaviors