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

NCT05508022 | Completed

• 1 other identifier: KaratayUF
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Distention; Child, Only

Keywords

Children; Enema; Anxiety; Fear; Pain; Breathing exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  20 minutes

• 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.

  20 minutes

• 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.

  20 minutes

Study Arms (1)

Breathing Exercise

EXPERIMENTAL

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

Behavioral: Breathing exercise

Interventions

Breathing exercise BEHAVIORAL

Before the enema is applied, breathing exercises will be applied to the participants in the intervention group.

Breathing Exercise

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Kto Karatay University

Konya, Turkey (Türkiye)

Location

Related 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

MeSH Terms

Conditions

Constipation; Dilatation, Pathologic; Anxiety Disorders; Pain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Mental Disorders; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Zeynep Padir, Msc

  Igdır State Hospital, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: May 9, 2023
• Primary Completion: May 10, 2023
• Study Completion: June 15, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

TU (1)