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| ID | Type | Description | Link |
|---|---|---|---|
| 20.478.486/3669 | Registry Identifier | Health Sciences Ethics Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Ball Group | Experimental | Participants will use a stress ball during enema administration. |
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| Video Distraction Group | Experimental | Participants will watch an aquarium video with music during enema administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Ball | Behavioral | Participants will hold and squeeze an individual stress ball throughout the enema administration as a distraction technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fear Level | Fear level measured using the Child Fear Scale (CFS). | Before and immediately after enema administration. |
| Anxiety Level | Anxiety level measured using the Children's Anxiety Scale-State (CAS-S). | Before and immediately after enema administration. |
| Pain Level | Pain level measured using the Wong-Baker FACES Pain Rating Scale. | Immediately after enema administration |
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Inclusion Criteria:
Children aged 6-12 years. Admitted to the pediatric emergency department. Scheduled for enema administration due to functional constipation or abdominal distension.
Able to communicate in Turkish. No cognitive or neurological impairment. No diagnosis of attention-deficit/hyperactivity disorder. No analgesic medication used within the previous 6 hours. Parent or legal guardian provides written informed consent, and the child provides assent.
Exclusion Criteria:
Acute abdominal conditions requiring emergency surgery (e.g., perforated appendicitis).
Hirschsprung disease or inflammatory bowel disease. Severe visual or hearing impairment that prevents participation. Refusal of the child or parent to participate. Inability to complete the study procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manisa Merkez Efendi State Hospital | Manisa | 45140 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Video Distraction | Behavioral | Participants will watch a 3-minute aquarium video accompanied by Mozart music during enema administration to provide audiovisual distraction. |
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