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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05010213
Other study ID # NAYDIN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date December 8, 2021

Study information

Verified date December 2021
Source Near East University, Turkey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 8, 2021
Est. primary completion date October 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Educational intervention
Educational intervention

Locations

Country Name City State
Cyprus Near East University Nicosia

Sponsors (1)

Lead Sponsor Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-care agency scale score level Score level of self-care agency before the patient education At the beginning of plaster treatment, an avarage of 1 hour
Primary Coping orientation to problems experienced (COPE) Score level of coping orientation to problems experienced before the patient education At the beginning of plaster treatment, an avarage of 1 hour
Secondary Self-care agency scale score level Score level of coping orientation to problems experienced after the patient education At the end of treatment, an avarage of 1 week
Secondary Coping orientation to problems experienced (COPE) Score level of coping orientation to problems experienced after the patient education At the end of treatment, an avarage of 1 week
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