Educational ProblemsNCT05010213
Plaster Patient Education With Roy Adaptation Model
A study testing Educational intervention in people with Educational Problems, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2021to 8 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With lower extremity fracture
- Have at least 6 weeks of plaster cast experience
Who cannot join
- Have communication problem
- Have restriction of movement before fracture
- Patient who can not speak very well Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Educational Problems
- Being tested
- Educational intervention
- Keywords
- Coping Skills, Casts, Surgical, Patient Education as Topic, Nursing Education, Self Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
Educational intervention
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | There will be no intervention to the control group. |
| Experimental group | Experimental | The experimental group will be given training based on the roy adaptation model. Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care agency scale score level
Score level of self-care agency before the patient education
Measured: At the beginning of plaster treatment, an avarage of 1 hour
Coping orientation to problems experienced (COPE)
Score level of coping orientation to problems experienced before the patient education
Measured: At the beginning of plaster treatment, an avarage of 1 hour
Secondary outcomes (2)
Self-care agency scale score level
Score level of coping orientation to problems experienced after the patient education
Measured: At the end of treatment, an avarage of 1 week
Coping orientation to problems experienced (COPE)
Score level of coping orientation to problems experienced after the patient education
Measured: At the end of treatment, an avarage of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Sep 2021
- Primary completion20 Oct 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida AYDIN, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010213
- Sponsor's protocol ID
- NAYDIN
- Status last verified
- Dec 2021
- First submitted
- 29 Jul 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given With the Roy Adaptation Model on the Self-care Agency and Coping Strategies of Patients With Plaster Casts.
- ClinicalTrials.gov ID
- NCT05010213
- Acronym / sponsor ID
- NAYDIN
- Conditions
- Educational Problems
- Keywords
- Coping Skills, Casts, Surgical, Patient Education as Topic, Nursing Education, Self Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 18 Aug 2021 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –There will be no intervention to the control group. |
| Experimental group | Experimental | Other: Educational interventionThe experimental group will be given training based on the roy adaptation model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- With lower extremity fracture
- Have at least 6 weeks of plaster cast experience
Key exclusion criteria (3 listed)
- Have communication problem
- Have restriction of movement before fracture
- Patient who can not speak very well Turkish
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 |
|---|---|---|
| Educational interventionEducational intervention | Other | Experimental group |
Primary outcome
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
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
2 secondary outcomes
Self-care agency scale score level
Time frame: 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
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 6 Jan 2022.
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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 Educational intervention in people with Educational Problems, run by Near East University, Turkey at 1 site in Cyprus.
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 2 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 6 Jan 2022. 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 Cyprus. 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?
Self-care agency scale score level (time frame: At the beginning of plaster treatment, an avarage of 1 hour). 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 6 Jan 2022; AzTrials last refreshed its copy on 29 Oct 2026.