The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT06112717
Collaborator
(none)
30
1
2
7.5
4

Study Details

Study Description

Brief Summary

The present study evaluates the effect of nursing care based on the Self-Care Deficit Nursing Theory on the knowledge and skills related to self-care among adolescents with Cystic Fibrosis.

Condition or Disease Intervention/Treatment Phase
  • Other: Supportive-Educative Nursing Care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are 2 group in the study. Intervention Group and Control Group. The control group received no intervention by principal researcher.There are 2 group in the study. Intervention Group and Control Group. The control group received no intervention by principal researcher.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis
Actual Study Start Date :
Feb 14, 2019
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Supportive-Educative Nursing Care
Adolescents in the intervention group were received Supportive-Educative Nursing Care based on Orem's Self Care Deficit Nursing Theory

No Intervention: Control Group

Adolescents in the control group received no intervention by the researcher.

Outcome Measures

Primary Outcome Measures

  1. The change in self care knowledge and skills of adolescents with Cystic Fibrosis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tuğçe TORUN, PhD, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier:
NCT06112717
Other Study ID Numbers:
  • HACETTEPEU-TUGCETORUN-001
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuğçe TORUN, PhD, Research Assistant, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023