The Effect of Nursing Care Program on Women With Endometriosis

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05402943
Collaborator
(none)
46
1
14.2
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
46 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
Jun 10, 2022
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Intervention Group

The group which interventions applied during study.

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

Behavioral: 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

Behavioral: Healthy Life Style Behaviours Scale II.
A questionnaire used to measure the Healthy Life Style Behaviours.

Behavioral: 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.

Control Group

None intervention applied.

Behavioral: 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

Behavioral: Healthy Life Style Behaviours Scale II.
A questionnaire used to measure the Healthy Life Style Behaviours.

Outcome Measures

Primary Outcome Measures

  1. The quality of life assessed by the EHP-5 [May 2021-June 2022]

    The quality of life of women with endometriosis is assessed by Endometriosis Health Profile Questionnaire-5 .

  2. Healthy lifestyle behaviours assessed by the HLBS II. [May 2021-June 2022]

    The healthy lifestyle behaviours of women with endometriosis is assessed by Healthy Lifestyle Behaviors Scale II (HLBSII).

Secondary Outcome Measures

  1. Satisfaction level of women assessed by questionnaire developed in line with the literature. [May 2021-June 2022]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 41 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Zeynep Kamil Women and Children Disease Hospital Istanbul Uskudar Turkey 34668

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

  • Study Director: Nevin SAHIN, Istanbul University-Cerrahpasa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ayse Gul BURSA, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05402943
Other Study ID Numbers:
  • IST.UNI.CERRAH.DEPT.OF NURSING
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ayse Gul BURSA, Principal Investigator, Istanbul University-Cerrahpasa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022