It is hypothesized that a plastic fracture orthosis significantly decreases time to healing in children with distal radial fracture using a plastic fracture orthosis compared to children using a conventional plaster cast.
From the aim,
It is comparison.
The Dependent Variable (DV) is: Healing time (in days).
Target of population is: Children with distal radial fracture.
Independent Variable (IV) has two levels:
Level 1: Using a conventional plaster cast.
Level 2: Using a plastic fracture orthosis.
I need to write 1200 words, Aim and Hypothesis are not counted. With at least 12 references.
The prescribed book MUST be a reference, it is:
Foundation of Clinical Research Applied to Practice. Third Edition. Leslie G Portny + Mary P. Watkins.
Research design (50 words):
Participants (300 words):
a- Sample: Describe the people you seek to attract into the study to form your sample & explain your choice.
We need to include:
The number of participants you will seek, their gender, age, medical condition, and other demographic information, and inclusion criteria & exclusion criteria [inclusion criteria is children with distal radial fracture, but we need to specify that to a common type of distal radial fracture among children]
[exclusion criteria, for example, we need to exclude children with other medical problems].
b- Recruitment: [ in this section, we need to explain how will we find our subjects, for example, we can start seeking for subjects in the Emergency Departments in hospitals]
Describe the process you will use to ETHICALLY recruit participants including:
The sampling techniques you will apply,
How their names and contact details will be obtained
From where they will be recruited
How they will be invited to participate [ I prefer Advertisement poster]
Who will approach participants to seek their participation?
Detailed of any reward or compensation you offer.
How consent will be indicated and documented
How permission will be gained from a parent or guardian. [as they are children]
The process must be clearly explain how you will ensure participation is purely voluntary.
Attach a draft of Advertisement letter, Consent letter, information statement and any other forms you will use.
Apparatus (150 words):
In this section,
Summarize the testing instruments you will use to collect data. [ in this case I suggest using X-ray as an instrument to know the healing time]
Procedures (750 words):
a- Data collection (600 words):
Fully describe the process you will undertake to ETHICALLY collect data while minimizing bias, including:
The number of contacts to be made with each participant (how many time patients will get X-ray for example),
What will happen during each contact,
Provision and Description of interventions. [in this case there are two interventions: conventional plaster cast, and plastic fracture orthosis]
How data will be recorded, [eg written questionnaire, direct electronic data entry. ( here we need to attach form showing Date of visit, Visit number, type of fracture, type of intervention, and healed or not Y/N question)
Your process must identify clearly any thing that may have ADVERSE COSEQUENCES or involve RISK of physical, emotional, social, legal or financial harm to the participants, and explain the steps you will take to minimize these risks. [ patient should be aware of the risk for example pain during moving patient to different positions during casting or X-ray.
Data Analysis (150 words):
Describe the process you will use to analyze the data, beginning from raw data and concluding with STATISTICAL ANALYSES.
Include in this section:
Your operational definitions of the variables,
Statement of the data type for the Dependent Variable (DV) & Independent Variable (IV/IF) and levels�
How the raw data will be compiled and processed,
Descriptive analysis techniques you will apply [ Mean or Standard Deviation ],
Statistical Analysis techniques you will use [ what test will you use, It is t-test for sure]
The appendix must include an advertisement poster & consent letter (for parent or guardians),and the assessment form that I mentioned in section 4, and any other forms you need to add.
-Advertisement poster should include:
State or imply favorable outcomes or benefits,
Promises of � free treatment � when the intent that that participants won�t incur any costs.
– �Dear Patient� letter:
Must include the same information and exclusion as flyer,
Obtaining patient contact details in ETHICALLY patient contact.
– The Assessment form should be a table, including as I mentioned before
Date of visit, Visit number, type of fracture, type of intervention, and healed or not Y/N question.
I need you please to reference (in text references) every thing, and to find proper references and references that written in the last few years, Literature references.
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