ConstipationNCT05508022
Determining the Effect of Breathing Exercise Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain
A study testing Breathing exercise in people with Constipation and Distention, run by KTO Karatay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Distention, Child, Only
- What is being tested?
- Breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Constipation, Distention, Child, Only
- Being tested
- Breathing exercise
- Keywords
- Children, Enema, Anxiety, Fear, Pain, Breathing exercise
- Medical subject headings
- Constipation, Dilatation, Pathologic, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseBehavioural
Before the enema is applied, breathing exercises will be applied to the participants in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise | Experimental | Breathing exercises will be applied to the participants in the experimental group. Receives: Behavioral: Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
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.
Measured: 20 minutes
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start9 May 2023
- Primary completion10 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Türkdüdükçü, KTO Karatay University
- Investigators
- Zeynep Padir, Msc, Study chair, Igdır State Hospital, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508022
- Sponsor's protocol ID
- KaratayUF
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Padir Z, Turk Dudukcu F. Effect of breathing exercise on enema-related anxiety, fear and pain in children: a randomized controlled trial. Psychol Health Med. 2026 Oct 26:1-14. doi: 10.1080/13548506.2026.2753800. Online ahead of print.
PubMed 42929448
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Breathing Exercise Technique Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain
- ClinicalTrials.gov ID
- NCT05508022
- Acronym / sponsor ID
- KaratayUF
- Conditions
- Constipation, Distention, Child, Only
- Keywords
- Children, Enema, Anxiety, Fear, Pain, Breathing exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise | Experimental | Behavioral: Breathing exerciseBreathing exercises will be applied to the participants in the experimental group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Developing complications during the enema procedure (intestinal perforation, bleeding, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exerciseBefore the enema is applied, breathing exercises will be applied to the participants in the intervention group. | Behavioural | Breathing Exercise |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 42929448Padir Z, Turk Dudukcu F. Effect of breathing exercise on enema-related anxiety, fear and pain in children: a randomized controlled trial. Psychol Health Med. 2026 Oct 26:1-14. doi: 10.1080/13548506.2026.2753800. Online ahead of print.
- Comparing the Effect of Two Methods of Distraction on the Pain Intensity Venipuncture in School-age Children: A Randomized Clinical TrialLink provided by the sponsor.
- Constipation and paediatric emergency department utilizationLink provided by the sponsor.
- Association between abdominal pain and fecal impaction grade assessed through radiography in constipated patients at a pediatric emergency serviceLink provided by the sponsor.
- Soap Suds Enemas Are Efficacious and Safe for Treating Fecal Impaction in Children With Abdominal PainLink provided by the sponsor.
- Developing a New One-Dimensional Scale to Measure Pain in Children: Pencil Pain ScaleLink provided by the sponsor.
- 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 TrialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Padir, Msc study chair
Igdır State Hospital, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Constipation and Distention, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the anxiety level of the experimental group in which breathing exercise was applied (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.