Plaster Patient Education With Roy Adaptation Model

Sponsor

Near East University, Turkey (Other)

Overall Status

Completed

CT.gov ID

NCT05010213

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

20.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Educational Problems	Other: Educational intervention	N/A

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

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized controlled clinical trialProspective randomized controlled clinical trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Oct 20, 2021

Actual Study Completion Date :

Dec 8, 2021

Arms and Interventions

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.	Other: Educational intervention Educational intervention

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.

Other: Educational intervention

Educational intervention

Outcome Measures

Primary Outcome Measures

Self-care agency scale score level [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) [At the beginning of plaster treatment, an avarage of 1 hour]
Score level of coping orientation to problems experienced before the patient education

Secondary Outcome Measures

Self-care agency scale score level [At the end of treatment, an avarage of 1 week]
Score level of coping orientation to problems experienced after the patient education
Coping orientation to problems experienced (COPE) [At the end of treatment, an avarage of 1 week]
Score level of coping orientation to problems experienced after the patient education

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Near East University	Nicosia		Cyprus	99138

Sponsors and Collaborators

Near East University, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nida AYDIN, Research assistant, Near East University, Turkey

ClinicalTrials.gov Identifier:

NCT05010213

Other Study ID Numbers:

NAYDIN

First Posted:

Aug 18, 2021

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nida AYDIN, Research assistant, Near East University, Turkey

Coping Skills

Casts, Surgical

Patient Education as Topic

Nursing Education

Self Care

Study Results

No Results Posted as of Jan 6, 2022