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

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.

Study Overview

• Status: Completed
• Conditions: Mastitis
• Intervention / Treatment: Other: Mastitis care teaching protocol

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group exposed to routine care.
Experimental: Study group; The study group received the sessions of "mastitis care teaching protocol".	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%.	Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
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.	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.	Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level using Numeric Pain Rating scale	Pain level as a symptom of mastitis was measured at base line using Tool III: Numeric Pain rating scale for both study and control groups. It was asked from each patient to rate pain level from 0 to10 with understanding that 0 is equal to no pain and 10 is equal to worst possible pain. At follow up "third week" pain level was measured again for both study and control groups with the same scale to test for change.	Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
Number of participants(study -control) who discontinued breast feeding	Lactating women in either groups (study -control) reported that they discontinued nursing their babies. This outcome was evaluated by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.	At the third week from base line assessment.
Number of participants (study -control) who completely cured from mastitis	Inflamed breast was evaluated for both groups (study- control), If it resolved and returned to normal condition or not. This outcome was evaluated clinically (signs & symptoms) by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.	At the third week from base line assessment.
Number of participants (study -control) who their condition complicated with formation of breast abscess.	Breast abscess is a complication of mastitis that will be formed within the inflamed breast tissue. This outcome was evaluated clinically (signs and symptoms) by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.	At the third week from base line assessment.
Number of mastitis recurrence among participants(study -control) .	The inflamed breast tissue re-inflamed again for the second time. This outcome was evaluated clinically (signs and symptoms) by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.	At the third week from base line assessment.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 2, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mastitis
• Other Study ID Numbers: Mastitis prognosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes: There is a plan to make IPD and related data dictionaries available.
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No