The Effect of Breathing Exercise With Pinwheel on the Quality of Life in Children With Cystic Fibrosis Disease: A Prospective Randomized Controlled Study

Cystic Fibrosis (CF) is an autosomal recessive genetic disorder that affects many organs simultaneously. The sinuses, lungs, intestines, pancreas, gallbladder, liver, reproductive organs, and sweat glands are affected by CF. The treatment of children with CF includes medication, diet therapy, pancreatic enzyme therapy, chest physiotherapy, and lung transplantation. When chest physiotherapy is not performed effectively and regularly, children have increased hospital admissions, prolonged hospitalization, restricted daily activities, loss of independence, decreased quality of life, and social isolation. The aim of this randomized controlled trial was to present the results of the effect of pinwheel breathing exercises on the quality of life in children with CF.

METHODS This study was conducted in a single-center, prospective randomized controlled design. The sample size of the study was calculated using G*Power 3.1.9.2 (Heinrich Heine University Düsseldorf, Germany). The sample size was found to be 35 for each group. The study authors considered possible sample losses during the study process. It was determined to conduct the study with a total of 70 children. There were 35 children in each group (intervention and control groups). Between January and April 2024, 81 children aged 6-11 years with CF who were enrolled in the Pediatric Chest Outpatient Clinic of Marmara University Pendik Training and Research Hospital were included in this study. Among these children, 70 children who met the inclusion criteria were included. Children who did not come to the Pediatric Chest Outpatient Clinic for routine controls (n = 10) and children whose parents refused to participate in the study (n = 1) were excluded.

Procedures:

Participants were assigned to their respective groups, and the pinwheels to be given to the intervention group were placed in locations to be used in the interviews. Vital signs, Child Health Status Diagnosis Form (CHSDF), Cystic Fibrosis Questionnaire Revised (CFQ-R), and Breathing Exercise Practice and Follow-up Form (BEPFF) and all records were documented by the first researcher. The first researcher has 2.5 years of experience as a pediatric intensive care and pediatric ward nurse. The pediatric chest outpatient clinic works in a single shift during the day (08:00-16:00). In this study, the following procedures were performed respectively. Initial assessments of children with CF registered in the pediatric chest outpatient clinic were performed between 08:00 and 16:00 at their own scheduled appointment hours. The parents of the children in the intervention group were informed about all stages of the research process and provided verbal and written consent. The children were randomly assigned to the groups by the simple randomization method. Randomization was made according to the daily examination appointment order of the pediatric pulmonology outpatient clinic of the hospital. Children with an odd number of appointments were included in the intervention group, and those with an even number were included in the control group. For example, the child whose examination appointment was in the 1st place was included in the intervention group, and the child whose appointment was in the 2nd place was included in the control group. This method was repeated until the sample size was reached. In this study, all assessments were performed in the same way for children in the intervention and control groups. Vital signs, pulmonary function test values, and quality of life data of the children were re-evaluated at various time points. These time points were: before the intervention and the first appointment day after the intervention (at least 3 months). Before the intervention covers the interval between the appointments scheduled between 08:00 and 16:00 for the child's first evaluation. After the intervention covers the interval between the appointments scheduled from 08:00 to 16:00 for the child's second evaluation after 3 months. Factors determining children's quality of life were evaluated twice, before and after the intervention. The vital signs and pulmonary function test values of the children were measured once on the day of the intervention (between 08:00 and 16:00 appointment hours). Console-type pulse oximeter and pulmonary function test device (spirometer) were used. All data except the vital signs of the children were asked to the mothers and children face to face, and their answers were recorded in the CFQ-R.

Instruments: