Clinical trial NCT05508022: 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
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Distention
Child, Only
Keywords: Children
Enema
Anxiety
Fear
Pain
Breathing exercise
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 106
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: Comparison of the anxiety level of the experimental group in which breathing exercise was applied
timeFrame: 20 minutes
measure: Comparison of the fear level of the experimental group in which breathing exercise was applied.
timeFrame: 20 minutes
measure: Comparison of the pain level of the experimental group in which breathing exercise was applied
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Kto Karatay University
Study officials:
affiliation: Igdır State Hospital, Turkey
name: Zeynep Padir, Msc
role: STUDY_CHAIR
References: