NCT05402943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

May 25, 2022

Last Update Submit

September 29, 2023

Conditions

Keywords

Endometriosis, Health Promotion Model, Nursing Care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Satisfaction level of women assessed by questionnaire developed in line with the literature.

    May 2021-June 2022

Study Arms (2)

Intervention Group

The group which interventions applied during study.

Behavioral: Nursing Care Program for EndometriosisBehavioral: EHP-5 Endometriosis Health Promotion Model.Behavioral: Healthy Life Style Behaviours Scale II.Behavioral: The Satisfaction Questionnaire for Nursing Care Program for women with Endometriosis.

Control Group

None intervention applied.

Behavioral: EHP-5 Endometriosis Health Promotion Model.Behavioral: Healthy Life Style Behaviours Scale II.

Interventions

Nursing Care Program for Endometriosis, developed in line with Health Promotion Model

Intervention Group

EHP-5 Endometriosis Health Promotion Model. A questionnaire used to measure the quality of life of women with endometriosis

Control GroupIntervention Group

A questionnaire used to measure the Healthy Life Style Behaviours.

Control GroupIntervention Group

A questionnaire used to measure the satisfaction levels of women with endometriosis who applied the Nursing Care Program for women with endometriosis.

Intervention Group

Eligibility Criteria

Age25 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All women diagnosed with endometriosis who applied to the outpatient clinic.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Zeynep Kamil Women and Children Disease Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 11506842BACKGROUND
  • 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.

    PMID: 15130031BACKGROUND
  • 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..

    BACKGROUND
  • 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.

    PMID: 25522117BACKGROUND
  • 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)

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23847114BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 21621771BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nevin SAHIN

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 2, 2022

Study Start

May 10, 2021

Primary Completion

January 15, 2022

Study Completion

May 15, 2022

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations