Skip to main content
OpenTrials
Completed

NCT Number: NCT07695428

Stress Ball and Video Distraction During Pediatric Enema

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation - Functional Abdominal Distension Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Merkez Efendi State Hospital

Manisa, 45140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stress ball

Behavioral

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

Video Distraction

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

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

Acronym: SAVE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.