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Enrolling by Invitation

NCT Number: NCT07297784

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

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.

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Key information

Conditions

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokat Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. FLACC pain scores

    Time frame: 1, 6, 12, and 24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

The Association Between Problematic Media Use and Postoperative Pain Severity in Pediatric Patients Undergoing Tonsillectomy: An Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Jun 26, 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.

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