Clinical trial NCT05974956: Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design
Official title: Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Exclusion Criteria:

1. Mental health problems
2. Visual or hearing problems
3. Uncooperative

Primary outcomes:
measure: Compare the difference between the mean knowledge of participants (study and control groups) regarding mastitis care and management at base line & follow up after three weeks.
timeFrame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
measure: Compare the difference between the mean practice of participants (study and control groups) regarding mastitis care and management at base line & follow up after three weeks.
timeFrame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
Secondary outcomes:
measure: Pain level using Numeric Pain Rating scale
timeFrame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
measure: Number of participants(study -control) who discontinued breast feeding
timeFrame: At the third week from base line assessment.
measure: Number of participants (study -control) who completely cured from mastitis
timeFrame: At the third week from base line assessment.
measure: Number of participants (study -control) who their condition complicated with formation of breast abscess.
timeFrame: At the third week from base line assessment.
measure: Number of mastitis recurrence among participants(study -control) .
timeFrame: At the third week from base line assessment.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
References: