AdenotonsillectomyNCT07297784
Impact of Problematic Media Use on Postoperative Pain in Children Undergoing Tonsillectomy
An observational study of Adenotonsillectomy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Adenotonsillectomy
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 4-11 years
- Scheduled for bilateral tonsillectomy
- Parent/guardian capable of completing questionnaires
- Parent/guardian willing to provide informed consent
Who cannot join
- Allergy, recent cold/upper respiratory infection
- NSAID use within 24 hours before surgery
- Any condition impairing pain assessment
- Refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Tokat Province, 60100
About this study
Official title: The Association Between Problematic Media Use and Postoperative Pain Severity in Pediatric Patients Undergoing Tonsillectomy: An Observational Study
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 6, 12, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297784
- Sponsor's protocol ID
- 25-MOBAEK-341
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the findings of this study are available from the corresponding author upon reasonable request. Interested researchers may contact the corresponding author via email and provide a brief description of their intended use.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Problematic Media Use and Postoperative Pain Severity in Pediatric Patients Undergoing Tonsillectomy: An Observational Study
- ClinicalTrials.gov ID
- NCT07297784
- Acronym / sponsor ID
- 25-MOBAEK-341
- Conditions
- Adenotonsillectomy
- Keywords
- Screen addiction, Problematic media use, Pediatric tonsillectomy, FLACC scale
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Children aged 4-11 years
- Scheduled for bilateral tonsillectomy
- Parent/guardian capable of completing questionnaires
- Parent/guardian willing to provide informed consent
Key exclusion criteria (4 listed)
- Allergy, recent cold/upper respiratory infection
- NSAID use within 24 hours before surgery
- Any condition impairing pain assessment
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. The data supporting the findings of this study are available from the corresponding author upon reasonable request. Interested researchers may contact the corresponding author via email and provide a brief description of their intended use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenotonsillectomy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC pain scores (time frame: 1, 6, 12, and 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.