- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112717
The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study included 30 adolescents who were equally divided into the intervention and control groups. The data were collected by using the Sociodemographic Data Form and the Self-Care Knowledge and Skills Evaluation Forms for Adolescents with Cystic Fibrosis. A total of seven home visits were conducted with the adolescents in the intervention group, during which individualized care plans were applied based on the Self-Care Deficit Nursing Theory. The self-care needs of the adolescents in the control group were identified based on data collected during two home visits conducted at the onset of the study and after 4.5 months.
As a result of the application of nursing interventions based on the Self-Care Deficit Nursing Theory, a statistically significant increase was noted in the self-care knowledge and skills of the adolescents in the intervention group (p<0.05). Additionally, nursing interventions and nursing diagnosis decreased significantly over time in all adolescents in the intervention group (p<0.05).
Orem's Self-Care Deficit Nursing Theory was useful in enhancing the self-care knowledge and skills of adolescents with Cystic Fibrosis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06100
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Cystic Fibrosis determined by a positive sweat test and/or the presence of two Cystic Fibrosis mutations,
- Aged between 12 and 18 years
- Living in the same Ankara
Exclusion Criteria:
- Adolescents with mental health issues
- Adolescents with an atypical form of Cystic Fibrosis (characterized by an absence of symptoms and no medication requirement)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Adolescents in the control group received no intervention by the researcher.
|
|
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Experimental: Nursing Care
Seven home visit was made to adolescent in the intervention group.
In the first and last visits only self-care knowledge and skills of adolescents were evaluated.
In the 2.,3.,4.,5.
and 6. home visits they received supportive-educational individualised nursing care based on Orem's Self Care Deficit Nursing Theory.
The applied nursing interventions varied based on the individual needs and the level of assistance required by each adolescent.
Each home visit lasted 30-60 minutes.
Adolescents were given an educational booklet containing information about self-care in cystic fibrosis.
|
Adolescents in the intervention group were received Supportive-Educative Nursing Care based on Orem's Self Care Deficit Nursing Theory
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in self care knowledge and skills of adolescents with Cystic Fibrosis
Time Frame: 18 weeks(4.5 months) after first enrollment of patient.
|
The change in self-care knowledge and skills of adolescents at the end of the research after the applied nursing interventions.
|
18 weeks(4.5 months) after first enrollment of patient.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hicran Çavuşoğlu, Professor, Head of Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey
- Study Director: Deniz Doğru, Professor, Pediatric Pulmonology Department, Faculty of Medicine, Hacettepe University, Turkey
- Principal Investigator: Tuğçe TORUN, PhD, Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HACETTEPEU-TUGCETORUN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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