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

October 9, 2023 updated by: Figen Türkdüdükçü, KTO Karatay University

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

Completed

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

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Konya, Turkey
        • KTO Karatay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Zeynep Padir, Msc, Igdır State Hospital, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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