Clinical trial NCT05402943: The Effect of Nursing Care Program on Women With Endometriosis
Official title: The Effect of Nursing Care Program Developed Based on Health Promotion Model on the Healthy Lifestyle Behaviors and Quality of Life of Women With Endometriosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Quality of Life
Healthy Life Style
Keywords: Endometriosis, Health Promotion Model, Nursing Care
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 46
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women diagnosed with endometriosis who applied to the outpatient clinic.

Brief summary: This study was carried out to determine the effect of the endometriosis nursing care program (ENCP) given to women with endometriosis in line with the Health Promotion Model, on the quality of life and healthy lifestyle behaviors of women.

Detailed description: This experimental study, which was conducted in a single-blind, with control group, prospective, randomized type in the first test-post-test order, was carried out in the endometriosis polyclinic of Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital.

In the preliminary evaluation, 46 women with Endometriosis Health Profile Questionnaire-5 (EHP-5) scores of 22 and above (50 and above in the 100 system) constituted the sample of the study, including 23 intervention and 23 control groups. While the Nursing Care Program for Women with Endometriosis (NCPE) was applied to the intervention group, only routine care was applied to the control group. Introductory Information Form, EHP-5, Healthy Lifestyle Behaviors Scale II (HLBSII), and Satisfaction Questionnaire for NCPE were used as data collection forms in the study.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with endometriosis,
* Being in the reproductive period,
* No communication barrier,
* Not having been diagnosed with a psychiatric illness,

Exclusion Criteria:

* Getting pregnant during the study,
* It was determined as wanting to leave the study,

Primary outcomes:
measure: The quality of life assessed by the EHP-5
timeFrame: May 2021-June 2022
measure: Healthy lifestyle behaviours assessed by the HLBS II.
timeFrame: May 2021-June 2022
Secondary outcomes:
measure: Satisfaction level of women assessed by questionnaire developed in line with the literature.
timeFrame: May 2021-June 2022
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Zeynep Kamil Women and Children Disease Hospital
state: Uskudar
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Nevin SAHIN
role: STUDY_DIRECTOR
References:
citation: Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001 Aug;98(2):258-64. doi: 10.1016/s0029-7844(01)01433-8.
citation: Jones G, Jenkinson C, Kennedy S. Development of the Short Form Endometriosis Health Profile Questionnaire: the EHP-5. Qual Life Res. 2004 Apr;13(3):695-704. doi: 10.1023/B:QURE.0000021321.48041.0e.
citation: Walker, S. N., & Hill-Polerecky, D. M. (1996). Psychometric evaluation of the health- promoting lifestyle profile II. Unpublished manuscript, University of Nebraska Medical Center, 120-26..
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citation: D'Alterio, M. N., Saponara, S., Agus, M., Laganà, A. S., Noventa, M., Loi, E. S., Feki, A., & Angioni, S., 2021, Medical and surgical interventions to improve the quality of life for endometriosis patients: A systematic review, Gynecological Surgery 18(1), 1-14. https://doi.org/10.1186/s10397-021-01096-5.
citation: De Graaff AA, D'Hooghe TM, Dunselman GA, Dirksen CD, Hummelshoj L; WERF EndoCost Consortium; Simoens S. The significant effect of endometriosis on physical, mental and social wellbeing: results from an international cross-sectional survey. Hum Reprod. 2013 Oct;28(10):2677-85. doi: 10.1093/humrep/det284. Epub 2013 Jul 11.
citation: Fedele, F., 2021, An Overview on the Psychological Impact of Endometriosis on Adolescent Girls' Life, Women's Health Bulletin. https://doi.org/10.30476/whb.2021.91557.1128.
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