Stress Ball and Video Distraction During Pediatric Enema

NCT07695428 | Completed

• 2 other identifiers: MCBU-PED-ENEMA-2026-00120.478.486/3669
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation - Functional; Abdominal Distension

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Immediately after enema administration

Study Arms (2)

Stress Ball Group

EXPERIMENTAL

Participants will use a stress ball during enema administration.

Behavioral: Stress Ball

Video Distraction Group

EXPERIMENTAL

Participants will watch an aquarium video with music during enema administration

Behavioral: Video Distraction

Interventions

Stress Ball BEHAVIORAL

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

Stress Ball Group

Video Distraction BEHAVIORAL

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

Video Distraction Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• Manisa Celal Bayar University: lead

Study Sites (1)

Manisa Merkez Efendi State Hospital

Manisa, 45140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)