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Stress Ball and Video Distraction During Pediatric Enema

Effects of Stress Ball Use and Video Distraction During Enema Administration on Fear, Anxiety, and Pain in Children in the Pediatric Emergency Department

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07695428
Acronym
SAVE
Enrollment
72
Registered
2026-07-10
Start date
2026-02-01
Completion date
2026-04-30
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Distension, Constipation - Functional

Keywords

Children, Stress Ball, Video Distraction, Fear, Anxiety, Pain

Brief 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. 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.

Interventions

BEHAVIORALStress Ball

Participants will hold and squeeze an individual stress ball throughout the enema administration as a distraction technique.

BEHAVIORALVideo Distraction

Participants will watch a 3-minute aquarium video accompanied by Mozart music during enema administration to provide audiovisual distraction.

Sponsors

Manisa Celal Bayar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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 use within the previous 6 hours Written informed consent provided by the parent or legal guardian and assent provided by the child

Exclusion criteria

Acute abdominal conditions requiring emergency surgery Diagnosis of 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

Design outcomes

Primary

MeasureTime frameDescription
Fear LevelBefore 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 LevelBefore 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 LevelImmediately after enema administrationPain 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026