The Effectiveness of a Stress Incontinence Care Protocol

NCT ID: NCT03866356

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-01-15

Brief Summary

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This study seeks to contribute to nursing practices by developing and stress incontinence care protocol with the help of the Star model and implementing this care protocol for the purpose of standardizing patient care outcomes.

Detailed Description

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To identify the effectiveness of a care protocol developed using the Star model on outcomes in female patients with stress incontinence.

Information and evidence needs to be translated into nursing practice and applied to clinical decision-making in stress incontinence cases. Evidence-based study models such as the Star model provide guidance on using evidence to develop clinical guidelines and care protocols. The Star model is designed to improve patient outcomes by creating a bridge between research and clinical practice. There is currently no published stress incontinence care protocol based on the Star model. Although there is one published study of a care protocol for urinary incontinence, this protocol was not drawn up on the basis of an evidence-based model.

Women that matched the sample criteria were recruited into the study. After their consent was obtained, the women were randomized into an intervention and a control group. The women in the intervention group were provided care according to stress incontinence care protocol. The control group received no intervention during the eight-week intervention period.

Conditions

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Stress Incontinence, Female Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

The intervention group received care according to the SICP (Table 2). One of the researchers gave each participant one-on-one education in line with SICP. They were also provided with the booklet that had been prepared in accordance with SICP. The participants were phoned every week for eight weeks and offered counseling within the scope of SICP and then were reevaluated at the end of eight weeks (Post-intervention). The participants were followed from the eighth to the twelfth week without any intervention (4-week post-intervention).

Group Type EXPERIMENTAL

intervention group

Intervention Type BEHAVIORAL

The women in the intervention group were provided care according to SICP

Control group

The control group received no intervention during the eight-week intervention period. The control group received standard care. The women were given no educational materials.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intervention group

The women in the intervention group were provided care according to SICP

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* The inclusion criteria were being female, ≥ 18 years, having an initial diagnosis of SI, being literate, having no sensory disorder affecting communication, and agreeing to participate in the research

Exclusion Criteria:

* The exclusion criteria were pregnancy, presence of a urinary tract infection and previous treatment for SI. The removal criteria were patient non-compliance with the protocol, failure in contacting the patient and the patient's wish to withdraw from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

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Emel Gülnar

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Kaya S, Akbayrak T, Toprak Celenay S, Dolgun A, Ekici G, Beksac S. Reliability and validity of the Turkish King's Health Questionnaire in women with urinary incontinence. Int Urogynecol J. 2015 Dec;26(12):1853-9. doi: 10.1007/s00192-015-2786-6. Epub 2015 Jul 26.

Reference Type BACKGROUND
PMID: 26209953 (View on PubMed)

Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.

Reference Type BACKGROUND
PMID: 23797972 (View on PubMed)

Stevens KR. The impact of evidence-based practice in nursing and the next big ideas. Online J Issues Nurs. 2013 May 31;18(2):4.

Reference Type BACKGROUND
PMID: 23758422 (View on PubMed)

Schaffer MA, Sandau KE, Diedrick L. Evidence-based practice models for organizational change: overview and practical applications. J Adv Nurs. 2013 May;69(5):1197-209. doi: 10.1111/j.1365-2648.2012.06122.x. Epub 2012 Aug 9.

Reference Type BACKGROUND
PMID: 22882410 (View on PubMed)

Zengin N, Pinar R. Reliability and validity of the continence self-efficacy scale in Turkish women with urinary incontinence. Nurs Health Sci. 2012 Sep;14(3):277-84. doi: 10.1111/j.1442-2018.2012.00692.x. Epub 2012 May 27.

Reference Type BACKGROUND
PMID: 22632069 (View on PubMed)

Other Identifiers

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KU

Identifier Type: -

Identifier Source: org_study_id

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