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

Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861739
• Other study ID #: 150
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Marmara University
• Contact: Hamide Arslan Tarus, Res. Asist.
• Phone: +905370656476
• Email: hamide.arslan[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Endometriosis
• Quality of Life
• Stress

Intervention

Behavioral:
• Endometriosis Self-care Support Program
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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul	Basibüyük

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.