Cystic FibrosisNCT06112717
The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis
A study testing Supportive-Educative Nursing Care in people with Cystic Fibrosis and Adolescence, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cystic Fibrosis, Adolescence, Self-care
- What is being tested?
- Supportive-Educative Nursing Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Adolescents with mental health issues
- Adolescents with an atypical form of Cystic Fibrosis (characterized by an absence of symptoms and no medication requirement)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Adolescence, Self-care
- Being tested
- Supportive-Educative Nursing Care
- Keywords
- Cystic Fibrosis, Adolescence, Self-care
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-Educative Nursing CareOther
Adolescents in the intervention group were received Supportive-Educative Nursing Care based on Orem's Self Care Deficit Nursing Theory
| Study group | Role | What they receive |
|---|---|---|
| Nursing Care | Experimental | 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. Receives: Other: Supportive-Educative Nursing Care |
| Control Group | No intervention | Adolescents in the control group received no intervention by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in self care knowledge and skills of adolescents with Cystic Fibrosis
The change in self-care knowledge and skills of adolescents at the end of the research after the applied nursing interventions.
Measured: 18 weeks(4.5 months) after first enrollment of patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start14 Feb 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe TORUN, Hacettepe University
- Investigators
- Hicran Çavuşoğlu, Professor, Study director, Head of Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, TurkeyDeniz Doğru, Professor, Study director, Pediatric Pulmonology Department, Faculty of Medicine, Hacettepe University, TurkeyTuğçe TORUN, PhD, Principal investigator, Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112717
- Sponsor's protocol ID
- HACETTEPEU-TUGCETORUN-001
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06112717
- Acronym / sponsor ID
- HACETTEPEU-TUGCETORUN-001
- Conditions
- Cystic Fibrosis, Adolescence, Self-care
- Keywords
- Cystic Fibrosis, Adolescence, Self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 group in the study. Intervention Group and Control Group. The control group received no intervention by principal researcher.
| Arm | Type | Receives |
|---|---|---|
| Nursing Care | Experimental | Other: Supportive-Educative Nursing CareSeven 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. |
| Control Group | No intervention | –Adolescents in the control group received no intervention by the researcher. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Adolescents with mental health issues
- Adolescents with an atypical form of Cystic Fibrosis (characterized by an absence of symptoms and no medication requirement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive-Educative Nursing CareAdolescents in the intervention group were received Supportive-Educative Nursing Care based on Orem's Self Care Deficit Nursing Theory | Other | Nursing Care |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicran Çavuşoğlu, Professor study director
Head of Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey
Deniz Doğru, Professor study director
Pediatric Pulmonology Department, Faculty of Medicine, Hacettepe University, Turkey
Tuğçe TORUN, PhD principal investigator
Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-Educative Nursing Care in people with Cystic Fibrosis and Adolescence, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.