NCT04832581

Brief Summary

The research was designed in a randomized controlled quasi-experimental type in order to reveal the effect of "Self-Care Behaviors Development Program for Urinary Tract Infections" prepared according to Orem's Self Care Model on the behavioral change in pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

January 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 1, 2021

Last Update Submit

April 1, 2021

Conditions

Urinary Tract Infection During Pregnancy

Keywords

Nursing Care During PregnancyOrem Self Care ModelUrinary Tract Infection

Outcome Measures

Primary Outcomes (3)

  • Genital Hygiene Behavior Inventory (GHBI)

    Likert type inventory consisting of 27 questions evaluating genital hygiene behaviors.Inventory was applied to all pregnant women participating in the study at the beginning and at the end of the study.

    2 weeks

  • Pregnant Information Form

    The form consists of 8 sections including sociodemographic information, information about pregnancy, urinary characteristics, hygiene habits, information about sexuality and pain status, examinations of the pregnant (such as full urinalysis) and the observation form. The form was created by researchers in line with the literature. It was used to take the first anamnesis of the pregnant woman.

    2 weeks

  • Pregnancy Evaluation Form

    The form consists of six sections including anthropometric information, information about pregnancy, urinary characteristics, hygiene habits, information about sexuality and pain status. The form was created by researchers in line with the literature. It was used for the post-training evaluation of the pregnant woman.

    2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group was informed that they participated in a study. After the data collection forms were introduced, written and verbal consents were obtained. Information has been received. The experimental group was included in the program based on the Orem Self Care Model. The program includes anatomical, physiological and hormonal changes during pregnancy, urinary system infections and preventive measures. A phone call was scheduled 2 weeks later. Second evaluation forms were applied. Both groups were informed that the study was concluded.

Behavioral: The Self-Care Behavior Development Program

Control Group

NO INTERVENTION

The control group was informed that they participated in a study. After the data collection forms were introduced, written and verbal consents were obtained. Information has been received. A phone call was scheduled 2 weeks later. Second evaluation forms were applied. After the research was completed, information was given in order to avoid bias and the brochure was delivered. Both groups were informed that the study was concluded.

Interventions

The Self-Care Behavior Development ProgramBEHAVIORAL

This program, which is based on the Orem Self Care Model, includes anatomical, physiological and hormonal changes, urinary system infections and preventive measures during pregnancy. The program is different from other researches in that it is based on a methodological theory and is created with up-to-date information.

Experimental Group

Eligibility Criteria

Age22 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe research is planned to be conducted with pregnant women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agreeing to participate in the study,
  • To speak and understand Turkish,
  • Access to patient records,
  • Pregnancy diagnosis by ultrasound

You may not qualify if:

  • The pregnant woman does not want to participate in the Self-Care Behaviors Development Program for Urinary Tract Infections prepared according to Orem's Self-Care Model,
  • Pregnant's use of corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Esra Çalışkan

Istanbul, Turkey (Türkiye)

Location

Nevin Hotun Şahin

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • Azami M, Jaafari Z, Masoumi M, Shohani M, Badfar G, Mahmudi L, Abbasalizadeh S. The etiology and prevalence of urinary tract infection and asymptomatic bacteriuria in pregnant women in Iran: a systematic review and Meta-analysis. BMC Urol. 2019 May 30;19(1):43. doi: 10.1186/s12894-019-0454-8.

    PMID: 31146773BACKGROUND

  • Easter SR, Cantonwine DE, Zera CA, Lim KH, Parry SI, McElrath TF. Urinary tract infection during pregnancy, angiogenic factor profiles, and risk of preeclampsia. Am J Obstet Gynecol. 2016 Mar;214(3):387.e1-7. doi: 10.1016/j.ajog.2015.09.101. Epub 2015 Oct 9.

    PMID: 26450405BACKGROUND

  • Amiri FN, Rooshan MH, Ahmady MH, Soliamani MJ. Hygiene practices and sexual activity associated with urinary tract infection in pregnant women. East Mediterr Health J. 2009 Jan-Feb;15(1):104-10.

    PMID: 19469432RESULT

  • Emiru T, Beyene G, Tsegaye W, Melaku S. Associated risk factors of urinary tract infection among pregnant women at Felege Hiwot Referral Hospital, Bahir Dar, North West Ethiopia. BMC Res Notes. 2013 Jul 25;6:292. doi: 10.1186/1756-0500-6-292.

    PMID: 23885968RESULT

  • Ghouri F, Hollywood A, Ryan K. A systematic review of non-antibiotic measures for the prevention of urinary tract infections in pregnancy. BMC Pregnancy Childbirth. 2018 Apr 13;18(1):99. doi: 10.1186/s12884-018-1732-2.

    PMID: 29653573RESULT

  • Haider G, Zehra N, Munir AA, Haider A. Risk factors of urinary tract infection in pregnancy. J Pak Med Assoc. 2010 Mar;60(3):213-6.

    PMID: 20225781RESULT

  • Stapleton A, Stamm WE. Prevention of urinary tract infection. Infect Dis Clin North Am. 1997 Sep;11(3):719-33. doi: 10.1016/s0891-5520(05)70382-2.

    PMID: 9378932RESULT

Related Links

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are two groups in the study, namely the experiment (33) and the control (34) group. The experimental group was included in the program based on the Orem Self Care Model. The program includes anatomical, physiological and hormonal changes during pregnancy, urinary system infections and preventive measures. In the experimental and control groups, the data were collected byface-to-face interview technique and telephone interviews. Pregnant Information Form, Pregnant Evaluation Form, Genital Hygiene Behavior Inventory (GHBI) and routine laboratory testsof pregnant women were used to collect data.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 6, 2021

Study Start

January 20, 2020

Primary Completion

June 3, 2020

Study Completion

July 8, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Research results will be shared.

Locations

TU(2)