Plaster Patient Education With Roy Adaptation Model

NCT ID: NCT05010213

Last Updated: 2022-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Educational Problems

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

There will be no intervention to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

The experimental group will be given training based on the roy adaptation model.

Group Type EXPERIMENTAL

Educational intervention

Intervention Type OTHER

Educational intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational intervention

Educational intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Near East University, Turkey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nida AYDIN

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Near East University

Nicosia, , Cyprus

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cyprus

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NAYDIN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect Of Counselıng
NCT04916717 COMPLETED NA
Diabetic Foot Education
NCT06655116 ENROLLING_BY_INVITATION