- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05010213
Plaster Patient Education With Roy Adaptation Model
December 15, 2021 updated by: Nida AYDIN, Near East University, Turkey
The Effect of Training Given With the Roy Adaptation Model on the Self-care Agency and Coping Strategies of Patients With Plaster Casts.
The aim of this study is to determine the effect of training given with the Roy adaptation model on the self-care agency and coping strategies of patients with plaster casts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
According to Global Burden of Disease data, fractures, which 436 million people suffer from each year, are the second most common musculoskeletal system disorder.
Plaster casts have been used in treatment of fractures since 1850, and they play an important role in extremity injuries and the healing of operative repairs.
In fractures treated with plaster, the bone alignment is corrected and this alignment is maintained with limited mobility.
However, if plaster casts are incorrectly applied or not properly taken care of, this may prevent the healing of fractures and can threaten the safety of patients.
Failure to comply with plaster-casting and cast-care principles can cause patients a range of immediate and delayed complications, including severe pain, edema, compartment syndrome, tissue necrosis, malunion, delayed union, nonunion, contracture, neurological problems, paralysis and pressure sores.
Orthopedic patients, and especially those with plaster casts, are susceptible to the side effects arising from immobility.
They thus need quality care and information to prevent or manage these side effects.
Nurses play an important role in prevention or early recognition of complications arising from plaster-casting and in providing the patient with information.
Orthopedic nursing requires special skills, knowledge and clinical judgement to provide the plaster cast-patient with safe, quality-care and to prevent complications.
Patient education and information are very important for those patients whose treatment continues at home after casting, in order that they can maintain their care and prevent complications.In this study, the sample size was determined with an effect size of 0.43 using the power analysis Gpower 3.1.9.7 program.
Accordingly, it was calculated that 29 patients were included in the intervention and control groups with a 5% margin of error and 80% power.
İt was decided to include at least 66 people in each working group with 10% surplus, considering that they might be lost in data collection.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nicosia, Cyprus, 99138
- Near east University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- With lower extremity fracture
- Have at least 6 weeks of plaster cast experience
Exclusion Criteria:
- Have communication problem
- Have restriction of movement before fracture
- Patient who can not speak very well Turkish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
There will be no intervention to the control group.
|
|
Experimental: Experimental group
The experimental group will be given training based on the roy adaptation model.
|
Educational intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-care agency scale score level
Time Frame: At the beginning of plaster treatment, an avarage of 1 hour
|
Score level of self-care agency before the patient education
|
At the beginning of plaster treatment, an avarage of 1 hour
|
Coping orientation to problems experienced (COPE)
Time Frame: At the beginning of plaster treatment, an avarage of 1 hour
|
Score level of coping orientation to problems experienced before the patient education
|
At the beginning of plaster treatment, an avarage of 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-care agency scale score level
Time Frame: At the end of treatment, an avarage of 1 week
|
Score level of coping orientation to problems experienced after the patient education
|
At the end of treatment, an avarage of 1 week
|
Coping orientation to problems experienced (COPE)
Time Frame: At the end of treatment, an avarage of 1 week
|
Score level of coping orientation to problems experienced after the patient education
|
At the end of treatment, an avarage of 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
October 20, 2021
Study Completion (Actual)
December 8, 2021
Study Registration Dates
First Submitted
July 29, 2021
First Submitted That Met QC Criteria
August 10, 2021
First Posted (Actual)
August 18, 2021
Study Record Updates
Last Update Posted (Actual)
January 6, 2022
Last Update Submitted That Met QC Criteria
December 15, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- NAYDIN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Educational Problems
-
Stanford UniversityNot yet recruitingEducational Problems
-
Tokat Gaziosmanpasa UniversityCompleted
-
Sakarya UniversityCompleted
-
Sakarya UniversityCompleted
-
European e-Learning School in Obstetric AnesthesiaFondazione Policlinico Universitario Agostino Gemelli IRCCSEnrolling by invitationEducational ProblemsItaly
-
Pamukkale UniversityCompleted
-
IlumensCompletedEducational ProblemsFrance
-
Ege UniversityCompleted
-
Selçuk UniversityCompletedEducational ProblemsTurkey
-
Seoul National University HospitalSMG-SNU Boramae Medical CenterCompleted
Clinical Trials on Educational intervention
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBacterial Infection | Clostridium DifficileUnited States
-
McGill University Health Centre/Research Institute...University of Manitoba; Sunnybrook Health Sciences Centre; University of Alberta and other collaboratorsCompletedPeptic Ulcer Hemorrhage
-
Universidad de GranadaNot yet recruitingAsthma | Allergy
-
Roswell Park Cancer InstituteCompletedCervical Cancer | Breast CancerUnited States
-
US Department of Veterans AffairsDuke UniversityCompletedAccidental FallsUnited States
-
Gary MorrowNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Azienda Unità Sanitaria Locale Reggio EmiliaCompletedMelanoma (Skin) | Educational ProblemsItaly
-
Goethe UniversityUnknownHealth Knowledge, Attitudes, PracticeGermany
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedBreast Cancer | LymphedemaUnited States
-
Claudia AristizábalUniversidad Nacional de Colombia; Universidad de Santander; Fundación Universitaria...Enrolling by invitationBurnout, Psychological | CaregiversColombia