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Completed

NCT Number: NCT05861739

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

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.

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Key information

Conditions

Endometriosis Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Quality of Life Stress Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Başıbüyük, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endometriosis Self-care Support Program

Behavioral

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.

Primary outcomes

  1. Self-Care Behaviors Scale in Endometriosis

    Time frame: 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.

  2. Endometriosis Health Profile

    Time frame: 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.

  3. Depression, Anxiety and Stress Scale

    Time frame: 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 outcomes

  1. Numerical Pain Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 17, 2023
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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