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EndometriosisNCT05402943

The Effect of Nursing Care Program on Women With Endometriosis

An observational study of Endometriosis and Quality of Life, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 41 years, women only
Conditions the study is for
Endometriosis, Quality of Life, Healthy Life Style
What is being tested?
Nursing Care Program for Endometriosis, EHP-5 Endometriosis Health Promotion Model. and Healthy Life Style Behaviours Scale II.
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 May 2021to 15 May 2022
How long will I take part?
8 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 41 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Zeynep Kamil Women and Children Disease Hospital

    Istanbul, Uskudar, 34668

Other trials in Turkey (Türkiye)

About this study

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.

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.

Read the 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.

Being tested
Nursing Care Program for Endometriosis, EHP-5 Endometriosis Health Promotion Model., Healthy Life Style Behaviours Scale II., The Satisfaction Questionnaire for Nursing Care Program for women with Endometriosis.
Keywords
Endometriosis, Health Promotion Model, Nursing Care
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing Care Program for EndometriosisBehavioural

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

  • EHP-5 Endometriosis Health Promotion Model.Behavioural

    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.Behavioural

    A questionnaire used to measure the Healthy Life Style Behaviours.

  • The Satisfaction Questionnaire for Nursing Care Program for women with Endometriosis.Behavioural

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

Study groups in NCT05402943
Study groupRoleWhat they receive
Intervention GroupThe group which interventions applied during study.
Receives: Behavioral: Nursing Care Program for Endometriosis; Behavioral: 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 GroupNone intervention applied.
Receives: Behavioral: EHP-5 Endometriosis Health Promotion Model.; Behavioral: Healthy Life Style Behaviours Scale II.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: May 2021-June 2022

  2. 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).

    Measured: May 2021-June 2022

Secondary outcomes (1)

  1. 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.

    Measured: May 2021-June 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start10 May 2021
  3. Primary completion15 Jan 2022
  4. Study completion15 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
46 participants (actual)
Target duration
8 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05402943
Sponsor's protocol ID
IST.UNI.CERRAH.DEPT.OF NURSING
Status last verified
Sep 2023
First submitted
25 May 2022
Last updated
2 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 11506842

  • 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.

    PubMed 15130031

  • 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.

    PubMed 25522117

  • 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.

    PubMed 23847114

  • 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.

    PubMed 21621771

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Quality of Life, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The quality of life assessed by the EHP-5 (time frame: May 2021-June 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05402943, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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