Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2017-06-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Experimental: Intervention group

Group Type EXPERIMENTAL

family empowerment program

Intervention Type BEHAVIORAL

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)

Control:no intervation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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family empowerment program

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes