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Completed

NCT Number: NCT05974956

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

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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • Mental health problems
  • Visual or hearing problems
  • Uncooperative

Treatment and study plan

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.

Primary outcomes

  1. 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%.

  2. 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.

Secondary outcomes

  1. Pain level using Numeric Pain Rating scale

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

    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.

  2. Number of participants(study -control) who discontinued breast feeding

    Time frame: At the third week from base line assessment.

    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.

  3. Number of participants (study -control) who completely cured from mastitis

    Time frame: At the third week from base line assessment.

    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.

  4. Number of participants (study -control) who their condition complicated with formation of breast abscess.

    Time frame: At the third week from base line assessment.

    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.

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

    Time frame: At the third week from base line assessment.

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: Mastitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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