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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05508022
Other study ID # KaratayUF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2023
Est. completion date June 15, 2023

Study information

Verified date October 2023
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date June 15, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Kto Karatay University Konya

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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