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CompletedNCT05508022Updated Oct 11, 2023

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

An interventional study of Breathing exercise in Constipation, Distention and Child, Only, sponsored by KTO Karatay University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by KTO Karatay University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Not applicable
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Constipation
  • Distention
  • Child, Only

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Keywords

  • Children
  • Enema
  • Anxiety
  • Fear
  • Pain
  • Breathing exercise
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 106 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

KTO Karatay University is the lead sponsor of 126 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Breathing Exercise

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

    Behavioral: Breathing exercise

Interventions

  • BehavioralBreathing exercise

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20 minutes

  2. 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.

    Time frame: 20 minutes

  3. 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.

    Time frame: 20 minutes

07

Study locations

1 site
  • Kto Karatay University
    Konya, Turkey
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05508022
Lead sponsor
KTO Karatay University
Responsible party
Figen Türkdüdükçü (Doctor Lecturer, KTO Karatay University) — Principal investigator
First posted
Aug 19, 2022
Start date
May 9, 2023
Primary completion
May 10, 2023
Completion
Jun 15, 2023
Last update
Oct 11, 2023

Study contacts

Zeynep Padir, Msc
study chair · Igdır State Hospital, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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