Stress Ball and Video Distraction During Pediatric Enema (SAVE)

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.

Study Overview

• Status: Completed
• Conditions: Constipation - Functional; Abdominal Distension
• Intervention / Treatment: Behavioral: Stress Ball; Behavioral: Video Distraction

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Manisa, Turkey (Türkiye), 45140
    • Manisa Merkez Efendi State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Ball Group; Participants will use a stress ball during enema administration.	Behavioral: Stress Ball; Participants will hold and squeeze an individual stress ball throughout the enema administration as a distraction technique.
Experimental: Video Distraction Group; Participants will watch an aquarium video with music during enema administration	Behavioral: Video Distraction; Participants will watch a 3-minute aquarium video accompanied by Mozart music during enema administration to provide audiovisual distraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Manisa Celal Bayar University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Children; Fear; Stress Ball; Video Distraction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: MCBU-PED-ENEMA-2026-001; 20.478.486/3669 (Registry Identifier: Health Sciences Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No