Clinical trial NCT03800459: Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis
Official title: Effect of a Family Empowerment Program on Coping With Stress, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Children with Cystic Fibrosis
Parents
Quality of Life
Coping with Stress
Problem Solving
family empowerment program
Nursing
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

A single-blinded, parallel group pretest and posttest design randomized controlled trial was used.

Data were collected over 5 months (January 2017-May 2017) from 48 participants in a medical faculty hospital. They were randomly assigned to the experimental (n = 24) and control (n = 24) groups. Nursing interventions applied to the experimental group for ten weeks with the intent of strengthening families consist of; providing individualized training and booklet concerning disease management and providing phone calls and consultancy services for the purpose of reinforcing the training and increasing the motivation. A routine polyclinic follow-up was applied to the control group. Problem Solving Inventory (PSI), Scale of Ways of Coping with Stress (SWCS), and The Cystic Fibrosis Questionnaire-Revised scale (CFQ-R) were used reliable and valid instruments. The data were evaluated using the Wilcoxon Signed Ranks test in evaluating dependent groups and the Mann-Whitney U test in independent groups.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Child and parents information form
timeFrame: 3 weeks
Secondary outcomes:
measure: Problem Solving Inventory (PSI)
timeFrame: 10 weeks
measure: Scale of Ways of Coping with Stress (SWCS)
timeFrame: 10 weeks
measure: The Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Eyalet/Yerleşke
Study officials:
affiliation: Selcuk University
name: Fatma Tas Arslan
role: STUDY_DIRECTOR
References: