Constipation - FunctionalSAVENCT07695428
Stress Ball and Video Distraction During Pediatric Enema
A study testing Stress Ball and Video Distraction in people with Constipation - Functional and Abdominal Distension, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of stress ball use and video distraction during enema administration on fear, anxiety, and pain levels in children treated in the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Constipation - Functional, Abdominal Distension
- What is being tested?
- Stress Ball and Video Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Apr 2026
- 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
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- An acute abdominal condition requiring emergency surgery.
- A diagnosis of Hirschsprung disease or inflammatory bowel disease.
- Severe visual or hearing impairment that prevents participation in the study.
- Refusal of the child or parent/legal guardian to participate.
- Inability to complete the study procedures.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Merkez Efendi State Hospital
Manisa, 45140
About this study
Official title: Effects of Stress Ball Use and Video Distraction During Enema Administration on Fear, Anxiety, and Pain in Children in the Pediatric Emergency Department
This randomized controlled trial aims to evaluate the effects of stress ball use and video distraction during enema administration on fear, anxiety, and pain levels in children treated in the pediatric emergency department. Children aged 6-12 years will be randomly assigned to either the stress ball group or the video distraction group. Fear, anxiety, and pain will be assessed using validated measurement tools before, during, and after the procedure. The findings are expected to provide evidence for effective non-pharmacological interventions to improve children's comfort during enema administration.
Read the detailed description
This randomized controlled trial aims to determine the effects of stress ball use and video distraction during enema administration on fear, anxiety, and pain levels in children aged 6-12 years treated in the pediatric emergency department. A total of 72 children will be randomly assigned to either the stress ball group or the video distraction group using block randomization. Fear, anxiety, and pain will be assessed using the Child Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), and the Wong-Baker FACES Pain Rating Scale. The findings of this study are expected to provide evidence for effective non-pharmacological interventions to improve children's comfort during enema administration. The study will be conducted at the Pediatric Emergency Department of Manisa Merkez Efendi State Hospital.
- Conditions
- Constipation - Functional, Abdominal Distension
- Being tested
- Stress Ball, Video Distraction
- Keywords
- Children, Stress Ball, Video Distraction, Fear, Anxiety, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallBehavioural
Participants will hold and squeeze an individual stress ball throughout the enema administration as a distraction technique.
Video DistractionBehavioural
Participants will watch a 3-minute aquarium video accompanied by Mozart music during enema administration to provide audiovisual distraction.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | Participants will use a stress ball during enema administration. Receives: Behavioral: Stress Ball |
| Video Distraction Group | Experimental | Participants will watch an aquarium video with music during enema administration Receives: Behavioral: Video Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear Level
Fear level measured using the Child Fear Scale (CFS). Fear will be assessed using the Child Fear Scale (CFS). The scale ranges from 0 to 4, with higher scores indicating greater fear and a worse outcome.
Measured: Before and immediately after enema administration.
Anxiety Level
Anxiety level measured using the Children's Anxiety Scale-State (CAS-S). Anxiety will be assessed using the Children's Anxiety Scale-State (CAS-S). The scale ranges from 0 to 10, with higher scores indicating greater anxiety and a worse outcome.
Measured: Before and immediately after enema administration.
Pain Level
Pain level measured using the Wong-Baker FACES Pain Rating Scale. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
Measured: Immediately after enema administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Feb 2026
- Primary completion1 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups: a stress ball group or a video distraction group during enema administration. Outcomes will be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695428
- Sponsor's protocol ID
- MCBU-PED-ENEMA-2026-001
- Other IDs
- 20.478.486/3669
- Acronym
- SAVE
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stress Ball Use and Video Distraction During Enema Administration on Fear, Anxiety, and Pain in Children in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT07695428
- Acronym / sponsor ID
- SAVE / MCBU-PED-ENEMA-2026-001
- Conditions
- Constipation - Functional, Abdominal Distension
- Keywords
- Children, Stress Ball, Video Distraction, Fear, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 10 Jul 2026 (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.
This randomized controlled trial aims to evaluate the effects of stress ball use and video distraction during enema administration on fear, anxiety, and pain levels in children treated in the pediatric emergency department. Children aged 6-12 years will be randomly assigned to either the stress ball group or the video distraction group. Fear, anxiety, and pain will be assessed using validated measurement tools before, during, and after the procedure. The findings are expected to provide evidence for effective non-pharmacological interventions to improve children's comfort during enema administration.
Detailed description
This randomized controlled trial aims to determine the effects of stress ball use and video distraction during enema administration on fear, anxiety, and pain levels in children aged 6-12 years treated in the pediatric emergency department. A total of 72 children will be randomly assigned to either the stress ball group or the video distraction group using block randomization. Fear, anxiety, and pain will be assessed using the Child Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), and the Wong-Baker FACES Pain Rating Scale. The findings of this study are expected to provide evidence for effective non-pharmacological interventions to improve children's comfort during enema administration. The study will be conducted at the Pediatric Emergency Department of Manisa Merkez Efendi State Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups: a stress ball group or a video distraction group during enema administration. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Behavioral: Stress BallParticipants will use a stress ball during enema administration. |
| Video Distraction Group | Experimental | Behavioral: Video DistractionParticipants will watch an aquarium video with music during enema administration |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- An acute abdominal condition requiring emergency surgery.
- A diagnosis of Hirschsprung disease or inflammatory bowel disease.
- Severe visual or hearing impairment that prevents participation in the study.
- Refusal of the child or parent/legal guardian to participate.
- Inability to complete the study procedures.
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 |
|---|---|---|
| Stress BallParticipants will hold and squeeze an individual stress ball throughout the enema administration as a distraction technique. | Behavioural | Stress Ball Group |
| Video DistractionParticipants will watch a 3-minute aquarium video accompanied by Mozart music during enema administration to provide audiovisual distraction. | Behavioural | Video Distraction Group |
Primary outcome
Fear Level
Time frame: Before and immediately after enema administration.
Fear level measured using the Child Fear Scale (CFS). Fear will be assessed using the Child Fear Scale (CFS). The scale ranges from 0 to 4, with higher scores indicating greater fear and a worse outcome.
Anxiety Level
Time frame: Before and immediately after enema administration.
Anxiety level measured using the Children's Anxiety Scale-State (CAS-S). Anxiety will be assessed using the Children's Anxiety Scale-State (CAS-S). The scale ranges from 0 to 10, with higher scores indicating greater anxiety and a worse outcome.
Pain Level
Time frame: Immediately after enema administration
Pain level measured using the Wong-Baker FACES Pain Rating Scale. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
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 22 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball and Video Distraction in people with Constipation - Functional and Abdominal Distension, run by Manisa Celal Bayar 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 0 inclusion and 5 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 22 Oct 2026. 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?
Fear Level (time frame: Before and immediately after enema administration.). 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?
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 22 Oct 2026.