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

NCT ID: NCT07297784

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-02-01

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.

Detailed Description

Parents of children aged 4-11 years who agree to participate will be enrolled (n=94). The data collection form includes sociodemographic characteristics of the child and family, media use habits of both the child and parents, parental attitudes toward screen exposure, and the Problematic Media Use Scale (PMUS). All children will undergo a detailed history, physical examination, and routine hematological and biochemical tests. Children with allergies, recent upper respiratory infections, asthma, chronic obstructive pulmonary disease, or those who have received NSAIDs within the past 24 hours will be excluded.

Tonsillectomy indications include recurrent tonsillitis and/or tonsillar hypertrophy. All patients will undergo bilateral tonsillectomy via classical extracapsular dissection under general anesthesia. Hemostasis will be achieved with bipolar cauterization and packing. Postoperatively, oral intake will be restricted for 4 hours, and all patients will receive identical analgesic management consisting solely of paracetamol (10 mg/kg) administered three times daily.

The Problematic Media Use Scale (PMUS) was developed by Domoff et al. in 2017 for children aged 4-11 years to assess problematic digital media use. The Turkish validation of both the long and short forms was conducted by Furuncu in 2019. Based on DSM-5 Internet Gaming Disorder criteria, the scale includes items scored on a 5-point Likert scale, with higher scores indicating more problematic use. The short form of PMUS will be used in this study.

Participants will be categorized into two groups based on PMUS scores. Pain intensity will be evaluated using the FLACC scale at the 1st, 6th, 12th, and 24th postoperative hours. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), scored 0-2 each, with total scores ranging from 0 to 10. A score of 0 indicates comfort, 1-3 mild discomfort, 4-6 moderate pain, and 7-10 severe pain or distress.

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.

Conditions

Adenotonsillectomy

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Ali Genc

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tokat Gaziosmanpasa University

Tokat Province, Tokat Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

25-MOBAEK-341

Identifier Type: -

Identifier Source: org_study_id