MastitisMastitisNCT05974956
Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design
A study testing Mastitis care teaching protocol in people with Mastitis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastitis
- What is being tested?
- Mastitis care teaching protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Mental health problems
- Visual or hearing problems
- Uncooperative
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mastitis
- Being tested
- Mastitis care teaching protocol
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastitis care teaching protocolOther
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 | Role | What they receive |
|---|---|---|
| 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". Receives: Other: Mastitis care teaching protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the third week from base line assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna A. Desouky, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974956
- Sponsor's protocol ID
- Mastitis prognosis
- Acronym
- Mastitis
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design
- ClinicalTrials.gov ID
- NCT05974956
- Acronym / sponsor ID
- Mastitis / Mastitis prognosis
- Conditions
- Mastitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group exposed to routine care. |
| Study group | Experimental | Other: Mastitis care teaching protocolThe study group received the sessions of "mastitis care teaching protocol". |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Mental health problems
- Visual or hearing problems
- Uncooperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mastitis care teaching protocolIt 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. | Other | Study group |
Primary outcome
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%.
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.
5 secondary outcomes
Pain level using Numeric Pain Rating scale
Time frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
Number of participants(study -control) who discontinued breast feeding
Time frame: At the third week from base line assessment.
Number of participants (study -control) who completely cured from mastitis
Time frame: At the third week from base line assessment.
Number of participants (study -control) who their condition complicated with formation of breast abscess.
Time frame: At the third week from base line assessment.
Number of mastitis recurrence among participants(study -control) .
Time frame: At the third week from base line assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastitis care teaching protocol in people with Mastitis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.