Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design

NCT ID: NCT05974956

Last Updated: 2023-08-03

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-04-30

Brief Summary

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Aim: Evaluate the effect of a nursing teaching protocol on mastitis prognosis. Research design: Quasi-experimental research design was utilized. A convenient sample of sixty adult female patients diagnosed with mastitis, Patients divided equally into two groups(study and control) thirty for each.

Detailed Description

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The study was conducted in the breast unit in general surgery department at Main Assiut University Hospital. A convenient sample of sixty adult female patients diagnosed with mastitis, their ages range from 20 to 65years old. Patients divided equally into two groups; thirty for each. Both groups had been assessed at base line using the following tools:

Tool (I): An interview questionnaire sheet Tool (II):Mastitis self-care practices Tool (III): Numeric pain rating scale Tool (IV): Mastitis prognosis sheet

The control group exposed to routine care and study group received mastitis teaching protocol. After three weeks; both groups had been reassessed by the same tools.

Data analysis had been performed by using the Statistical Package for the Social Sciences (SPSS) Categorical variables described by number and percent (N, %). Continuous variables described by mean and standard deviation (Mean, SD). Chi-square test and Fisher exact test used to compare between categorical variables .T-test and Pearson's chi-square used to appear the association between patients' knowledge, practice, and mastitis prognosis before implementation of nursing teaching protocol and three weeks post.

Conditions

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Mastitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi experimental research design that test for change through manipulation of the independent variable. However, in this study, it lacks one of the three key properties of an experimental design "randomization".

The dependent variables (mastitis knowledge, self -care practice, pain level, and complications associated with mastitis) were measured and compared at base line for both control and study groups, then intervention was introduced to the study group. After three weeks; the dependent variables for both groups were evaluated to test the difference.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Medical researcher "N" assessed the prognosis of mastitis using tool IV" mastitis prognosis sheet for all patients "control - study" at follow up without knowing the study group who received the nursing teaching protocol

Study Groups

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Control group

The control group exposed to routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

The study group received the sessions of "mastitis care teaching protocol".

Group Type EXPERIMENTAL

Mastitis care teaching protocol

Intervention Type OTHER

It was developed by the authors based on previous similar studies, articles and library resources. It was introduced to the study group in the form of face to face sessions plus a hand out copy. It consisted of three parts; (1): Theoretical part about mastitis (definition, types, clinical manifestation, possible causes, diagnosis and management). (2):Self-care practices, and (3):Recommendations regarding dietary measures, rest, medication and follow up.

Interventions

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Mastitis care teaching protocol

It was developed by the authors based on previous similar studies, articles and library resources. It was introduced to the study group in the form of face to face sessions plus a hand out copy. It consisted of three parts; (1): Theoretical part about mastitis (definition, types, clinical manifestation, possible causes, diagnosis and management). (2):Self-care practices, and (3):Recommendations regarding dietary measures, rest, medication and follow up.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

1. Mental health problems
2. Visual or hearing problems
3. Uncooperative
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amna A. Desouky, MD

Assistant professor of Medical Surgical Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Nursing

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mastitis prognosis

Identifier Type: -

Identifier Source: org_study_id

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