Impact of Problematic Media Use on Postoperative Pain in Children Undergoing Tonsillectomy

NCT07297784 | Enrolling By Invitation

• 1 other identifier: 25-MOBAEK-341
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to investigate whether problematic media use is associated with postoperative pain severity in children aged 4-11 years undergoing tonsillectomy. A total of 94 parents who consent to participate and have children within the target age range will be included. Data will be collected using a structured questionnaire covering sociodemographic characteristics, family and child media habits, parental attitudes toward screen use, and the Problematic Media Use Scale (PMUS). Postoperative pain will be assessed using the FLACC scale at multiple time points within the first 24 hours after surgery.

Conditions

Adenotonsillectomy

Keywords

Screen addiction; Problematic media use; Pediatric tonsillectomy; FLACC scale

Outcome Measures

Primary Outcomes (1)

• FLACC pain scores

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale is a validated behavioral pain assessment tool used in pediatric patients who are unable to self-report pain reliably. It consists of five categories:Face, Legs, Activity, Cry, Consolability. Each category is scored from 0 to 2, resulting in a total score ranging from 0 to 10, where higher scores indicate more severe pain. Scores are interpreted as follows: 0: Relaxed and comfortable 1-3: Mild discomfort 4-6: Moderate pain 7-10: Severe pain or significant distress In this study, FLACC scores will be recorded at 1, 6, 12, and 24 hours postoperatively.

  1, 6, 12, and 24 hours postoperatively

Study Arms (1)

Pediatric Patients Undergoing Adenotonsillectomy

All participants scheduled for elective adenotonsillectomy will complete the short-form Problematic Media Use Scale (PMUS) in the preoperative period. All patients will undergo a standardized surgical procedure performed by the same surgical team, and postoperative analgesia will be administered according to institutional protocol, consisting of weight-based paracetamol dosing for the first 24 hours. Postoperative pain severity will be assessed using the FLACC scale at 1, 6, 12, and 24 hours after surgery. The primary aim of this observational study is to evaluate the correlation between PMUS scores and postoperative pain levels in children following adenotonsillectomy.

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Sample size was calculated based on a Type I error of 0.05, power of 0.80, and an expected correlation coefficient of r = 0.30 (low-level association) between problematic media use and pain score. This yielded a required sample of 85 participants. Accounting for approximately 10% attrition, the study aims to enroll 94 children.

You may qualify if:

• Children aged 4-11 years
• Scheduled for bilateral tonsillectomy
• Parent/guardian capable of completing questionnaires
• Parent/guardian willing to provide informed consent

You may not qualify if:

• Allergy, recent cold/upper respiratory infection
• NSAID use within 24 hours before surgery
• Any condition impairing pain assessment
• Refusal of consent

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Tokat Province, 60100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available starting 6 months after publication and will remain accessible for 5 years

Locations

TU (1)