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

NCT05861739 | Completed

• 1 other identifier: 150
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Quality of Life; Depression; Anxiety; Stress

Keywords

Endometriosis; Self-care support program; Quality of Life; Motivational interview; Self-care behaviors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Women in the control group will receive standard treatment. Training and motivational interviewing will not be applied.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Başıbüyük, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Nurdan Demirci, Prof.

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 17, 2023
• Study Start: May 16, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)