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

Not Applicable

Recruiting

• Conditions: Depression; Endometriosis; Stress; Quality of Life; Anxiety
• Interventions: Behavioral: Endometriosis Self-care Support Program

• Registration Number: NCT05861739
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-14
• Study First Posted: 2023-05-17
• Status Verified: 2024-04
• Study Start: 2024-04-15
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Self-Care Behaviors Scale in Endometriosis	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Başıbüyük, Turkey