Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482710
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
The Effect of Breathing Exercise With Pinwheel on the Quality of Life in Children With Cystic Fibrosis Disease
Sponsor:
Maltepe University
Organization:
Maltepe University
Study Overview
Official Title:
The Effect of Breathing Exercise With Pinwheel on the Quality of Life in Children With Cystic Fibrosis Disease A Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 GPower 3192 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 25 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 0800-1600 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 0800 and 1600 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 0800 and 1600 for the childs first evaluation After the intervention covers the interval between the appointments scheduled from 0800 to 1600 for the childs second evaluation after 3 months Factors determining childrens 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 0800 and 1600 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
Data were collected using the Child Health Status Diagnostic Form CHSDF the Cystic Fibrosis Questionnaire Revised CFQ-R and the Breathing Exercise Practice and Follow-up Form BEPFF The CFQ-R and BEPFF were developed by the researcher and the counselor after reviewing the relevant literature Child Health Status Diagnosis Form CHSDF In the first part of this form there are three open-ended questions about the childs date of diagnosis other diseases and medications that the child is constantly taking The second part of the form consists of three sections These sections include the initial and second assessments If the initial assessment is to be made the initial assessment box will be filled in and if the second assessment is to be made the second assessment box will be filled in The evaluation parameters for each section are specified In this study the CFQ-R form was used for the 6-11 age group This form consists of two parts and all questions are equally weighted In the first part there are five questions about the childs date of birth gender absence from school in the last two weeks due to vacation or non-health-related reasons racial origin and grade level In the second part there are 35 questions assessing childrens physical functioning questions 1-6 emotional functioning questions 7-14 social functioning questions 151619 treatment burden questions 171829 respiratory questions 31-34 and digestive findings question 35 in the last two weeks
The scale score is made with the online application on httpscfqr-appnetlifyappquestionnaire prepared by Quittner et al It is calculated by obtaining a score between 0-100 for each sub-heading Higher scores indicate better quality of life Breathing Exercise Practice and Follow-up Form BEPFF This form is used to describe how the children in the study group should perform the breathing exercise during the breathing exercise with the pinwheel It is composed of seven rows with instructions Opposite each row there are seven columns with 2-week evaluation times and two columns for each evaluation time to be marked morning and evening were added The boxes in front of the morning and evening breathing exercises were marked with a check In the study a pinwheel was used to ensure and improve the continuity of childrens breathing exercises and to increase lung capacity This pinwheel has a structure consisting of multiple small wings mounted on a handle It consists of 8 wings with an 18 cm diameter and is 38 cm in total length The pinwheel is usually made of durable paper material so it can be used repeatedly The easy rotating structure of the pinwheel makes it simple and easy for children to use These features ensure that children aged three and above can easily use the pinwheel
Intervention
Children in the study and control groups enrolled in the pediatric chest outpatient clinic were monitored with a pulse oximetry device and pulmonary function test device Vital signs and pulmonary function test values were measured and recorded at their scheduled appointments between 0800 and 1600 on the day of the intervention Before the intervention initial assessment the childrens information was recorded in the pretest CFQ-R questionnaire Each child in the intervention group was given a pinwheel at their appointment time The child was given the BEPFF and instructions on how to use the form were explained in detail In line with the BEPFF the child was told to sit in a chair suitably remove their surgical mask and take the pinwheel in the hand that they dominantly use In line with BEPFF the child was instructed to perform the breathing exercise with the pinwheel and whether the practice was performed correctly was evaluated in detail The child repeated the breathing exercise several times in order to perform it correctly
The child who was observed to perform the breathing exercise correctly in accordance with the BEPFF was instructed to perform this exercise twice a day in the morning and in the evening for 3 months at home In order to encourage the children to continue the breathing exercises regularly weekly reminder messages were sent via phone messaging for 3 months Children in the control group were not given a pinwheel and BEPFF was not applied Children in this group continued their routine treatment processes After the intervention evaluations second evaluation of the children in the intervention and control groups were conducted at the follow-up appointments scheduled 3 months later Vital signs and pulmonary function test values were measured and recorded at their scheduled appointments between 0800 and 1600 Factors affecting quality of life were asked face-to-face and the answers were recorded on the post-test CFQ-R questionnaire
METHODS This study was conducted in a single-center prospective randomized controlled design The sample size of the study was calculated using GPower 3192 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 25 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 0800-1600 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 0800 and 1600 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 0800 and 1600 for the childs first evaluation After the intervention covers the interval between the appointments scheduled from 0800 to 1600 for the childs second evaluation after 3 months Factors determining childrens 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 0800 and 1600 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
Data were collected using the Child Health Status Diagnostic Form CHSDF the Cystic Fibrosis Questionnaire Revised CFQ-R and the Breathing Exercise Practice and Follow-up Form BEPFF The CFQ-R and BEPFF were developed by the researcher and the counselor after reviewing the relevant literature Child Health Status Diagnosis Form CHSDF In the first part of this form there are three open-ended questions about the childs date of diagnosis other diseases and medications that the child is constantly taking The second part of the form consists of three sections These sections include the initial and second assessments If the initial assessment is to be made the initial assessment box will be filled in and if the second assessment is to be made the second assessment box will be filled in The evaluation parameters for each section are specified In this study the CFQ-R form was used for the 6-11 age group This form consists of two parts and all questions are equally weighted In the first part there are five questions about the childs date of birth gender absence from school in the last two weeks due to vacation or non-health-related reasons racial origin and grade level In the second part there are 35 questions assessing childrens physical functioning questions 1-6 emotional functioning questions 7-14 social functioning questions 151619 treatment burden questions 171829 respiratory questions 31-34 and digestive findings question 35 in the last two weeks
The scale score is made with the online application on httpscfqr-appnetlifyappquestionnaire prepared by Quittner et al It is calculated by obtaining a score between 0-100 for each sub-heading Higher scores indicate better quality of life Breathing Exercise Practice and Follow-up Form BEPFF This form is used to describe how the children in the study group should perform the breathing exercise during the breathing exercise with the pinwheel It is composed of seven rows with instructions Opposite each row there are seven columns with 2-week evaluation times and two columns for each evaluation time to be marked morning and evening were added The boxes in front of the morning and evening breathing exercises were marked with a check In the study a pinwheel was used to ensure and improve the continuity of childrens breathing exercises and to increase lung capacity This pinwheel has a structure consisting of multiple small wings mounted on a handle It consists of 8 wings with an 18 cm diameter and is 38 cm in total length The pinwheel is usually made of durable paper material so it can be used repeatedly The easy rotating structure of the pinwheel makes it simple and easy for children to use These features ensure that children aged three and above can easily use the pinwheel
Intervention
Children in the study and control groups enrolled in the pediatric chest outpatient clinic were monitored with a pulse oximetry device and pulmonary function test device Vital signs and pulmonary function test values were measured and recorded at their scheduled appointments between 0800 and 1600 on the day of the intervention Before the intervention initial assessment the childrens information was recorded in the pretest CFQ-R questionnaire Each child in the intervention group was given a pinwheel at their appointment time The child was given the BEPFF and instructions on how to use the form were explained in detail In line with the BEPFF the child was told to sit in a chair suitably remove their surgical mask and take the pinwheel in the hand that they dominantly use In line with BEPFF the child was instructed to perform the breathing exercise with the pinwheel and whether the practice was performed correctly was evaluated in detail The child repeated the breathing exercise several times in order to perform it correctly
The child who was observed to perform the breathing exercise correctly in accordance with the BEPFF was instructed to perform this exercise twice a day in the morning and in the evening for 3 months at home In order to encourage the children to continue the breathing exercises regularly weekly reminder messages were sent via phone messaging for 3 months Children in the control group were not given a pinwheel and BEPFF was not applied Children in this group continued their routine treatment processes After the intervention evaluations second evaluation of the children in the intervention and control groups were conducted at the follow-up appointments scheduled 3 months later Vital signs and pulmonary function test values were measured and recorded at their scheduled appointments between 0800 and 1600 Factors affecting quality of life were asked face-to-face and the answers were recorded on the post-test CFQ-R questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None