NCT05010213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

July 29, 2021

Last Update Submit

December 15, 2021

Conditions

Educational Problems

Keywords

Coping SkillsCasts, SurgicalPatient Education as TopicNursing EducationSelf Care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Self-care agency scale score level

    At the end of treatment, an avarage of 1 week

  • Coping orientation to problems experienced (COPE)

    At the end of treatment, an avarage of 1 week

Study Arms (2)

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.

Other: Educational intervention

Interventions

Educational interventionOTHER

Educational intervention

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With lower extremity fracture
  • Have at least 6 weeks of plaster cast experience

You may not qualify if:

  • Have communication problem
  • Have restriction of movement before fracture
  • Patient who can not speak very well Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University

Nicosia, 99138, Cyprus

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 18, 2021

Study Start

September 1, 2021

Primary Completion

October 20, 2021

Study Completion

December 8, 2021

Last Updated

January 6, 2022

Record last verified: 2021-12

Locations

CY(1)