The Effect of Breathing Exercise With Pinwheel on the Quality of Life in Children With Cystic Fibrosis Disease

NCT06482710 | Completed

• 1 other identifier: 2024/05-26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to present the results of the effect of pinwheel breathing exercises on the quality of life in children with Cystic Fibrosis (CF). In this randomized controlled study, 81 children with CF who were being monitored by the treatment team in the pediatric chest polyclinic of a state hospital and meeting the inclusion criteria were divided equally into two groups. The children in the first group (intervention group) were instructed to perform breathing exercises with a pinwheel twice a day, at a convenient time in the morning and in the evening, every day for 3 months in their own homes according to the Breathing Exercise Tracking Form (BETF) and to fill in the required fields of the form during this process. The children in the second group (control group) did not perform the pinwheel breathing exercise. The quality of life of the children in both groups was evaluated with the Cystic Fibrosis Questionnaire-Revised (CFQ-R) (age group 6-11).

Conditions

Nursing Caries; Breathing Exercise

Keywords

Child; Cystic fibrosis; Breathing exercise; Pinwheel; Therapeutic play; Quality of life

Outcome Measures

Primary Outcomes (1)

• Identifying children's quality of life

  The child's routine implementation and follow-up of the breathing exercise was assessed.

  3 months of routine implementation and follow-up of breathing exercise and change in quality of life of children.

Study Arms (2)

Pinwheel Group

EXPERIMENTAL

Children in the intervention group with CF were given pinwheel breathing exercises.

Device: Pinwheel

Control Group

NO INTERVENTION

The children in the control group were not given pinwheel breathing exercises and continued with their own breathing exercise routines.

Interventions

Pinwheel DEVICE

The children in the intervention group were given breathing exercises with pinwheels.

Pinwheel Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Those diagnosed with cystic fibrosis at least 1 year ago
• Those who were accompanied by their parents during the research
• Those who can speak and understand Turkish
• Children whose parents voluntarily accepted the study were included in the study.

You may not qualify if:

• Those with mental, auditory and visual problems
• Those with physical disabilities (limitation of movement in the use of upper extremities and congenital muscle diseases)
• Those who stopped doing breathing exercises with the pinwheel during the research follow-up period
• Children with a clinical course of acute exacerbation (the presence of at least a few of the following signs and symptoms: cough with high fever, increased sputum quantity, bloody sputum, more than 10% decrease in pulmonary function test value (FEV1), fatigue, weight loss, dyspnea) were not included in the study

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University School of Nursing Istanbul, Maltepe, Turkey.

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Selay Deniz

  Research Assistant at Maltepe University School of Nursing Istanbul, Turkey.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: December 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: May 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

TU (1)