The Effect of Nursing Care Program on Women With Endometriosis

Quality of Life Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402943
• Other study ID #: IST.UNI.CERRAH.DEPT.OF NURSING
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: September 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 41 Years

Eligibility

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,

Related Conditions & MeSH terms

• Endometriosis
• Healthy Life Style
• Quality of Life

Intervention

Behavioral:
• Nursing Care Program for Endometriosis
Nursing Care Program for Endometriosis, developed in line with Health Promotion Model
• EHP-5 Endometriosis Health Promotion Model.
EHP-5 Endometriosis Health Promotion Model. A questionnaire used to measure the quality of life of women with endometriosis
• Healthy Life Style Behaviours Scale II.
A questionnaire used to measure the Healthy Life Style Behaviours.
• The Satisfaction Questionnaire for Nursing Care Program for women with Endometriosis.
A questionnaire used to measure the satisfaction levels of women with endometriosis who applied the Nursing Care Program for women with endometriosis.

Locations

Country	Name	City	State
Turkey	Istanbul Zeynep Kamil Women and Children Disease Hospital	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Bahar, Z., Beser, A., Gördes, N., Ersin, F., & Kissal, A. (2008). Saglikli Yasam Biçimi Davranislari Ölçegi II'nin geçerlik ve güvenirlik çalismasi. C.Ü. Hemsirelik 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. — View 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.

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. — View 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. — View 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. — View Citation

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. — View 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..

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of life assessed by the EHP-5	The quality of life of women with endometriosis is assessed by Endometriosis Health Profile Questionnaire-5 .	May 2021-June 2022
Primary	Healthy lifestyle behaviours assessed by the HLBS II.	The healthy lifestyle behaviours of women with endometriosis is assessed by Healthy Lifestyle Behaviors Scale II (HLBSII).	May 2021-June 2022
Secondary	Satisfaction level of women assessed by questionnaire developed in line with the literature.	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.	May 2021-June 2022