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

Sponsor
Marmara University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05861739
Collaborator
(none)
58
1
2
9
6.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Endometriosis Self-care Support Program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Mar 1, 2024
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Self-Care Behaviors Scale in Endometriosis [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 [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 [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 Outcome Measures

  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.]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Istanbul Başıbüyük Turkey 34854

Sponsors and Collaborators

  • Marmara University

Investigators

  • Study Director: Nurdan Demirci, Prof., Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT05861739
Other Study ID Numbers:
  • 150
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023