- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05402943
The Effect of Nursing Care Program on Women With Endometriosis
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Uskudar
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Istanbul, Uskudar, Turkey, 34668
- Istanbul Zeynep Kamil Women and Children Disease Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention Group
The group which interventions applied during study.
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Nursing Care Program for Endometriosis, developed in line with Health Promotion Model
EHP-5 Endometriosis Health Promotion Model.
A questionnaire used to measure the quality of life of women with endometriosis
A questionnaire used to measure the Healthy Life Style Behaviours.
A questionnaire used to measure the satisfaction levels of women with endometriosis who applied the Nursing Care Program for women with endometriosis.
|
|
Control Group
None intervention applied.
|
EHP-5 Endometriosis Health Promotion Model.
A questionnaire used to measure the quality of life of women with endometriosis
A questionnaire used to measure the Healthy Life Style Behaviours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The quality of life assessed by the EHP-5
Time Frame: May 2021-June 2022
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The quality of life of women with endometriosis is assessed by Endometriosis Health Profile Questionnaire-5 .
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May 2021-June 2022
|
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Healthy lifestyle behaviours assessed by the HLBS II.
Time Frame: May 2021-June 2022
|
The healthy lifestyle behaviours of women with endometriosis is assessed by Healthy Lifestyle Behaviors Scale II (HLBSII).
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May 2021-June 2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction level of women assessed by questionnaire developed in line with the literature.
Time Frame: May 2021-June 2022
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The Satisfaction levels measured with a questionnaire developed in line with the literature, of the women in the intervention group who were applied Nursing Care Program for Women with Endometriosis (NCPE), developed by researcher in line with the Health Promotion Model.
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May 2021-June 2022
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Collaborators and Investigators
Investigators
- Study Director: Nevin SAHIN, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
General Publications
- 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.
- 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.
- 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..
- Selcuk S, Sahin S, Demirci O, Aksoy B, Eroglu M, Ay P, Cam C. Translation and validation of the Endometriosis Health Profile (EHP-5) in patients with laparoscopically diagnosed endometriosis. Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:41-4. doi: 10.1016/j.ejogrb.2014.11.039. Epub 2014 Dec 4.
- Bahar, Z., Beşer, A., Gördes, N., Ersin, F., & Kıssal, A. (2008). Sağlıklı Yaşam Biçimi Davranışları Ölçeği II'nin geçerlik ve güvenirlik çalışması. C.Ü. Hemşirelik Yüksekokulu Dergisi, 12(1)
- 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.
- 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.
- 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.
- Fourquet J, Baez L, Figueroa M, Iriarte RI, Flores I. Quantification of the impact of endometriosis symptoms on health-related quality of life and work productivity. Fertil Steril. 2011 Jul;96(1):107-12. doi: 10.1016/j.fertnstert.2011.04.095. Epub 2011 May 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IST.UNI.CERRAH.DEPT.OF NURSING
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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