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

NCT05974956 | Completed

• 1 other identifier: Mastitis prognosis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 completely cured from mastitis

  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.

• Number of mastitis recurrence among participants(study -control) .

  At the third week from base line assessment.

Study Arms (2)

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".

Other: Mastitis care teaching protocol

Interventions

Mastitis care teaching protocol 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.

Study group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Inclusion criteria: 1. Adult women 2. Age from 20 to 65 yrs. 3. Clinical diagnosis of mastitis 4. Lactational or non-lactational mastitis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Mental health problems
• Visual or hearing problems
• Uncooperative

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Nursing

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Mastitis

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Medical Surgical Nursing

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: August 3, 2023
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: April 30, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

EG (1)