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

NCT ID: NCT05508022

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2023-06-15

Brief Summary

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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

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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.

Conditions

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Constipation Distention Child, Only

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Breathing Exercise

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

Group Type EXPERIMENTAL

Breathing exercise

Intervention Type BEHAVIORAL

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

Interventions

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Breathing exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KTO Karatay University

OTHER

Sponsor Role lead

Responsible Party

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Figen Türkdüdükçü

Doctor Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Padir, Msc

Role: STUDY_CHAIR

Igdır State Hospital, Turkey

Locations

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Kto Karatay University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://ijp.mums.ac.ir/article_11038.html

Comparing the Effect of Two Methods of Distraction on the Pain Intensity Venipuncture in School-age Children: A Randomized Clinical Trial

https://pubmed.ncbi.nlm.nih.gov/29479200/

Constipation and paediatric emergency department utilization

https://pubmed.ncbi.nlm.nih.gov/31495541/

Association between abdominal pain and fecal impaction grade assessed through radiography in constipated patients at a pediatric emergency service

https://pubmed.ncbi.nlm.nih.gov/26655947/

Soap Suds Enemas Are Efficacious and Safe for Treating Fecal Impaction in Children With Abdominal Pain

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8786543/

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

https://pubmed.ncbi.nlm.nih.gov/30099726/

The effectiveness of a health promotion and stress-management intervention program in a sample of obese children and adolescents

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10333038/

Effects of breathing exercise techniques on the pain and anxiety of burn patients: A systematic review and meta-analysis

https://pubmed.ncbi.nlm.nih.gov/30944985/

Relaxation-guided imagery reduces perioperative anxiety and pain in children: a randomized study

https://pubmed.ncbi.nlm.nih.gov/31889358/

Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study

https://pubmed.ncbi.nlm.nih.gov/32173165/

The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey

https://europepmc.org/article/med/30466144

Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study.

https://pubmed.ncbi.nlm.nih.gov/23449608/

Medical management of constipation

https://pubmed.ncbi.nlm.nih.gov/37427680/

Psychosocial factors impacting antegrade continence enema outcomes in pediatric patients

Other Identifiers

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KaratayUF

Identifier Type: -

Identifier Source: org_study_id

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