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

August 23, 2025 updated by: Marmara University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Başıbüyük
      • Istanbul, Başıbüyük, Turkey (Türkiye), 34854
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
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
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.
No Intervention: Control group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nurdan Demirci, Prof., Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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