Back to resultsThe Effect of the Self-Care Support Program on Women With Endometriosis
Primary Purpose
Endometriosis, Quality of Life, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endometriosis Self-care Support Program
Sponsored by
About this trial
This is an interventional supportive care trial for Endometriosis focused on measuring Endometriosis, Self-care support program, Quality of Life, Motivational interview, Self-care behaviors
Eligibility Criteria
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.
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Endometriosis Self Care Support Program (Endometriosis Training and Motivational Interview) will be applied to the women in the intervention group.
Women in the control group will receive standard treatment. Training and motivational interviewing will not be applied.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05861739
Brief Title
The Effect of the Self-Care Support Program on Women With Endometriosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Quality of Life, Depression, Anxiety, Stress
Keywords
Endometriosis, Self-care support program, Quality of Life, Motivational interview, Self-care behaviors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Endometriosis Self Care Support Program (Endometriosis Training and Motivational Interview) will be applied to the women in the intervention group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women in the control group will receive standard treatment. Training and motivational interviewing will not be applied.
Intervention Type
Behavioral
Intervention Name(s)
Endometriosis Self-care Support Program
Intervention Description
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 Outcome Measure Information:
Title
Self-Care Behaviors Scale in Endometriosis
Description
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.
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.
Title
Endometriosis Health Profile
Description
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.
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.
Title
Depression, Anxiety and Stress Scale
Description
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.
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.
Secondary Outcome Measure Information:
Title
Numerical Pain Scale
Description
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).
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamide Arslan Tarus, Res. Asist.
Phone
+905370656476
Email
hamide.arslan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nurdan Demirci, Prof.
Phone
+902167775732
Email
nurdandemirci@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurdan Demirci, Prof.
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University
City
Istanbul
State/Province
Başıbüyük
ZIP/Postal Code
34854
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of the Self-Care Support Program on Women With Endometriosis
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