Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis
1 other identifier
interventional
48
1 country
1
Brief Summary
Parents of children with cystic fibrosis (CF) experience high levels of stress and problems. Family empowerment interventions provide important support for many patients with CF and their families. However,there is a lack of research exploring the effects of such empowerment programs on coping, and Problem Solving among parents, and Quality of Life in Children with CF. The present study aimed to assess the effect of a family empowerment program-based nursing intervention on parents coping with stress and problem solving, and quality of life children with CF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
December 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2017
CompletedFirst Submitted
Initial submission to the registry
December 28, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedJanuary 11, 2019
January 1, 2019
2 months
December 28, 2018
January 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child and parents information form
The form was developed to define baseline characteristics and was based on previous literature. The questionnaire included questions regarding the sociodemographic characteristics of the participants, such as age, gender, educational level, income, duration of treatment and diagnosis.
3 weeks
Secondary Outcomes (3)
Problem Solving Inventory (PSI)
10 weeks
Scale of Ways of Coping with Stress (SWCS)
10 weeks
The Cystic Fibrosis Questionnaire-Revised (CFQ-R)
10 weeks
Study Arms (2)
Experimental: Intervention group
EXPERIMENTALExperimental: Intervention group
Control:no intervation group
NO INTERVENTIONControl:no intervation group
Interventions
The empowerment program-nursing interventions were given in 6 sessions in the experimental group Session 1: Individualized training: General information about CF, respiratory system involvement and treatment process, airway cleaning in CF, drug applications (45-50 min) Session 2:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min).Session 3:Phone calls:Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min) Session 4:Individualized training:protection from infections, nutrition and psychosocial support (45 min) Session 5:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min) Session 6:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min)
Eligibility Criteria
You may qualify if:
- Children aged 6-18 years old;
- Pulmonary functions Forced Expiratory Volume (FEV 1) over 40%
- being able to communicate in Turkish,
- voluntary parents in the study.
You may not qualify if:
- had mental disorders;
- receiving mechanical ventilation;
- Being in the process of lung transplantation;
- having a sister/brother who died due to CF
- Being in enteral or parenteral feeding;
- having a chronic disease other than CF.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selcuk University
Konya, Eyalet/Yerleşke, 42200, Turkey (Türkiye)
Related Publications (1)
Donmez H, Tas Arslan F. The Effectiveness of a Parent Empowerment Intervention for Caregivers of Children with Cystic Fibrosis: A Randomized Controlled Trial. Compr Child Adolesc Nurs. 2024 Dec;47(4):267-283. doi: 10.1080/24694193.2024.2411986. Epub 2024 Oct 9.
PMID: 39382937DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fatma Tas Arslan
Selcuk University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blindness in the study was done by data collectors and statisticians. The data were collected by the nurse who did not know who is in the experiment and control group. To reduce selection bias and to control the variables that may have an effect on outcome variables, random assignment was made to the experimental and the control group by a statistician who did not know the names and characteristics of the parents of and children with CF. The analysis of the data coded according to the groups was made by a statistician. After the statistical analyses were completed and the research report was written, the researcher explained the coding for the experimental and control group.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2018
First Posted
January 11, 2019
Study Start
December 14, 2016
Primary Completion
February 26, 2017
Study Completion
June 2, 2017
Last Updated
January 11, 2019
Record last verified: 2019-01