- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05508022
Determining the Effect of Breathing Exercise Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain
Determination of the Effect of Breathing Exercise Technique Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain
In this study, it was aimed to determine the effect of breathing exercise applied before the enema procedure, which causes fear, pain and anxiety in children aged 6-12 years who applied to the pediatric emergency service, on fear, pain and anxiety in children. This research is in pretest-posttest, parallel group, randomized controlled experimental design.
The universe of the research consists of children aged 6-12 years who applied to the pediatric emergency department of Iğdır State Hospital (Turkey) between May 2022 and June 2022.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, it was aimed to determine the effect of breathing exercise applied before the enema procedure, which causes fear, pain and anxiety in children aged 6-12 years who applied to the pediatric emergency service, on fear, pain and anxiety in children. This research is in pretest-posttest, parallel group, randomized controlled experimental design.
The universe of the research consists of children aged 6-12 years who applied to the pediatric emergency department of Iğdır State Hospital (Turkey) between May 2022 and June 2022.
In the study, the pre-test scores of the pain, fear and anxiety levels of the children were compared and it was found that the pain, fear and anxiety levels of the intervention and control groups were moderate, and there was no difference between the groups. This result is important in terms of evaluating the effectiveness of the initiative.
In the study, a significant difference was found between the pain, fear and anxiety levels of the intervention and control groups after breathing exercise. Accordingly, the pain, fear and anxiety levels of the intervention group were significantly lower than the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey
- KTO Karatay University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 6-12 years of age
- Administering an enema because of constipation or distension
- There should be no obstacle to the enema procedure
- Child and parent agree to participate in the study
Exclusion Criteria:
- Having a mental disability
- Having any problems with hearing, vision, hearing
- Taking analgesics within the last 6 hours
- Having an additional illness that may cause pain
Removal criteria were as follows:
- Developing complications during the enema procedure (intestinal perforation, bleeding, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breathing Exercise
Breathing exercises will be applied to the participants in the experimental group.
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Before the enema is applied, breathing exercises will be applied to the participants in the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the anxiety level of the experimental group in which breathing exercise was applied
Time Frame: 20 minutes
|
Before the enema application, the participants in the experimental group will be given breathing exercises.
Thus, it is aimed to prevent the child from experiencing anxiety that may result from enema application.
With this application, the effect of breathing exercise on anxiety will be monitored.
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20 minutes
|
Comparison of the fear level of the experimental group in which breathing exercise was applied.
Time Frame: 20 minutes
|
Before the enema application, the participants in the experimental group will be given breathing exercises.
Thus, it is aimed to prevent the child from experiencing fear that may arise from enema application.
With this application, the effect of breathing exercise on fear will be monitored.
|
20 minutes
|
Comparison of the pain level of the experimental group in which breathing exercise was applied
Time Frame: 20 minutes
|
Before the enema application, the participants in the experimental group will be given breathing exercises.
Thus, it is aimed to prevent the child from experiencing pain that may result from enema application.
With this application, the effect of breathing exercise on pain will be monitored.
|
20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zeynep Padir, Msc, Igdır State Hospital, Turkey
Publications and helpful links
Helpful Links
- Comparing the Effect of Two Methods of Distraction on the Pain Intensity Venipuncture in School-age Children: A Randomized Clinical Trial
- Constipation and paediatric emergency department utilization
- Association between abdominal pain and fecal impaction grade assessed through radiography in constipated patients at a pediatric emergency service
- Soap Suds Enemas Are Efficacious and Safe for Treating Fecal Impaction in Children With Abdominal Pain
- Developing a New One-Dimensional Scale to Measure Pain in Children: Pencil Pain Scale
- The Effect of Breathing Exercise Using Bubble Blower on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 10 Years: A Crossover Randomized Clinical Trial
- The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents
- Effects of breathing exercise techniques on the pain and anxiety of burn patients: A systematic review and meta-analysis
- Relaxation-guided imagery reduces perioperative anxiety and pain in children: a randomized study
- Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study
- The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey
- Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study.
- Medical management of constipation
- Psychosocial factors impacting antegrade continence enema outcomes in pediatric patients
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayUF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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