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Determining the Effect of Breathing Exercise Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain

Primary Purpose

Constipation, Distention, Child, Only

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing exercise
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Constipation focused on measuring Children, Enema, Anxiety, Fear, Pain, Breathing exercise

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Enema ordered to the child by the physician
  • The consent of the child and family to participate in the study
  • The child's openness to communication
  • The child's ability to perceive the anxiety scale
  • The child does not have any other condition that affects the pain
  • The child has not used analgesics in the past six hours

Exclusion Criteria:

  • The child has a mental and/or physical disability

Sites / Locations

  • Kto Karatay University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breathing Exercise

Arm Description

Breathing exercises will be applied to the participants in the experimental group.

Outcomes

Primary Outcome Measures

Comparison of the anxiety level of the experimental group in which breathing exercise was applied
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.
Comparison of the fear level of the experimental group in which breathing exercise was applied.
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.
Comparison of the pain level of the experimental group in which breathing exercise was applied
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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2022
Last Updated
October 9, 2023
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT05508022
Brief Title
Determining the Effect of Breathing Exercise Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain
Official Title
Determination of the Effect of Breathing Exercise Technique Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Distention, Child, Only
Keywords
Children, Enema, Anxiety, Fear, Pain, Breathing exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The research groups consisted of 106 (per group: 53) children who met the sample selection criteria. Children were randomly assigned to intervention and control groups. Assignment of children to groups was done by an independent statistician to ensure confidentiality and avoid bias. In this study, stratified randomization method was used to assign children to groups. In randomized controlled experimental studies, the number of cases in each group is required to be balanced and similar in terms of prognostic factors (such as age and gender). With the stratified randomization method, differences and undesirable situations between study groups are tried to be minimized. The permutation method is used to achieve this balance (Kahan ve ark., 2015). In this study, children were stratified according to age (6-9 and 10-12) and gender (female, male) variables.
Masking
None (Open Label)
Masking Description
Blinding of the participants and the nursing researcher who delivered the intervention was not possible due to the nature of the intervention. Veri toplama sürecinde yanlılığı önlemek için; lavman işleminden önce ve sonra klinkte çalışan bağımsız bir gözlemci hemşire tarafından ölçekler uygulandı. Before data collection, randomization was performed by the statistician by coding the intervention and control groups as "A" and "B". Analysis of the data was performed by a statistician to avoid bias in the evaluation of the data. After analyzing and interpreting the data during the statistical process, the codes of the intervention and control groups of the study were revealed. The statistician was blinded during the analysis of study data.
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing Exercise
Arm Type
Experimental
Arm Description
Breathing exercises will be applied to the participants in the experimental group.
Intervention Type
Behavioral
Intervention Name(s)
Breathing exercise
Intervention Description
Before the enema is applied, breathing exercises will be applied to the participants in the intervention group.
Primary Outcome Measure Information:
Title
Comparison of the anxiety level of the experimental group in which breathing exercise was applied
Description
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.
Time Frame
20 minutes
Title
Comparison of the fear level of the experimental group in which breathing exercise was applied.
Description
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.
Time Frame
20 minutes
Title
Comparison of the pain level of the experimental group in which breathing exercise was applied
Description
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.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Padir, Msc
Organizational Affiliation
Igdır State Hospital, Turkey
Official's Role
Study Chair
Facility Information:
Facility Name
Kto Karatay University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://ijp.mums.ac.ir/article_11038.html
Description
Comparing the Effect of Two Methods of Distraction on the Pain Intensity Venipuncture in School-age Children: A Randomized Clinical Trial
URL
https://pubmed.ncbi.nlm.nih.gov/29479200/
Description
Constipation and paediatric emergency department utilization
URL
https://pubmed.ncbi.nlm.nih.gov/31495541/
Description
Association between abdominal pain and fecal impaction grade assessed through radiography in constipated patients at a pediatric emergency service
URL
https://pubmed.ncbi.nlm.nih.gov/26655947/
Description
Soap Suds Enemas Are Efficacious and Safe for Treating Fecal Impaction in Children With Abdominal Pain
URL
https://www.innovationinfo.org/journal-of-pediatrics-and-infants/article/Developing-a-New-One-Dimensional-Scale-to-Measure-Pain-in-Children-Pencil-Pain-Scale
Description
Developing a New One-Dimensional Scale to Measure Pain in Children: Pencil Pain Scale
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8786543/
Description
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
URL
https://pubmed.ncbi.nlm.nih.gov/30099726/
Description
The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10333038/
Description
Effects of breathing exercise techniques on the pain and anxiety of burn patients: A systematic review and meta-analysis
URL
https://pubmed.ncbi.nlm.nih.gov/30944985/
Description
Relaxation-guided imagery reduces perioperative anxiety and pain in children: a randomized study
URL
https://pubmed.ncbi.nlm.nih.gov/31889358/
Description
Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study
URL
https://pubmed.ncbi.nlm.nih.gov/32173165/
Description
The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey
URL
https://europepmc.org/article/med/30466144
Description
Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study.
URL
https://pubmed.ncbi.nlm.nih.gov/23449608/
Description
Medical management of constipation
URL
https://pubmed.ncbi.nlm.nih.gov/37427680/
Description
Psychosocial factors impacting antegrade continence enema outcomes in pediatric patients

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Determining the Effect of Breathing Exercise Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain

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