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Clinical Trials/NCT05974956
NCT05974956CompletedNot Applicable

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

Assiut University1 site in 1 country60 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Exclusion Criteria:
  • •Mental health problems
  • •Visual or hearing problems
  • •Uncooperative

Exclusion Criteria

  • •Mental health problems
  • •Visual or hearing problems
  • •Uncooperative

Arms & Interventions

Control group

No Intervention

The control group exposed to routine care.

Study group

Experimental

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

Intervention: Mastitis care teaching protocol (Other)

Outcomes

Primary Outcomes

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.

Time Frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks

The performance of participants (study and control groups) regarding mastitis care and management had been assessed twice (baseline- follow up) using: Tool II: "Mastitis self-care practices". Tool II: It was structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing. Scoring: A total score of 60% or higher considered as adequate self-care practices and less than 60% considered as inadequate. Three points scale used to grade the steps. Two points for doing correctly. One point for doing incorrectly and zero point for not doing at all.

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.

Time Frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks

The knowledge of participants(study and control groups) regarding mastitis care and management had been assessed twice( base line - follow up) using: Tool I: An interview questionnaire sheet (part 2) Tool I: It was structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing. Each answered question scored from 0 to 3 marks as follows; 3 marks for complete correct answer, 2 marks for incomplete correct answer, 1 mark for incorrect answer and zero for not known answer. The range of total score lies between 0-30, the scoring system interpreted in the results into satisfactory and unsatisfactory; satisfactory: if the total knowledge score is ≥ 60% and unsatisfactory if the total knowledge score is \< 60%.

Secondary Outcomes

  • Number of mastitis recurrence among participants(study -control) .(At the third week from base line assessment.)
  • Number of participants (study -control) who completely cured from mastitis(At the third week from base line assessment.)
  • Pain level using Numeric Pain Rating scale(Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks)
  • Number of participants(study -control) who discontinued breast feeding(At the third week from base line assessment.)
  • Number of participants (study -control) who their condition complicated with formation of breast abscess.(At the third week from base line assessment.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amna A. Desouky, MD

Assistant professor of Medical Surgical Nursing

Assiut University

Study Sites (1)

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