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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Selcuk University
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Child and parents information form
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Experimental: Intervention group
Experimental: Intervention group
Intervention: family empowerment program (Behavioral)
Control:no intervation group
Control:no intervation group
Outcomes
Primary Outcomes
Child and parents information form
Time Frame: 3 weeks
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.
Secondary Outcomes
- Scale of Ways of Coping with Stress (SWCS)(10 weeks)
- The Cystic Fibrosis Questionnaire-Revised (CFQ-R)(10 weeks)
- Problem Solving Inventory (PSI)(10 weeks)
Investigators
Fatma Taş Arslan
Professor
Selcuk University