- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242872
Screen Addiction and Postoperative Pain
Association Between Smartphone Addiction and Postoperative Pain and Analgesic Consumption in Adult Patients Undergoing Elective Rhinoplasty: A Prospective Observational Study
Study Overview
Status
Conditions
Detailed Description
Problematic smartphone use-often referred to as smartphone addiction-has emerged as a significant behavioral concern worldwide. Prior research has demonstrated associations between excessive smartphone use and anxiety, depression, sleep disturbances, impaired attention, and increased musculoskeletal discomfort. Moreover, psychological factors such as stress, anxiety, and cognitive attention patterns are known to modulate postoperative pain perception.
Individuals with higher levels of smartphone addiction commonly exhibit elevated anxiety, restlessness, and depressive symptoms, which may heighten pain sensitivity and interfere with postoperative pain coping mechanisms. However, current literature includes limited evidence directly examining the relationship between smartphone addiction and postoperative pain outcomes.
This single-center prospective observational study will include adult patients aged 18-45 years undergoing elective rhinoplasty surgery under general anesthesia. Eligible participants will be ASA physical status I-II and without psychiatric disorders, chronic analgesic or psychotropic medication use, communication difficulties, prior rhinoplasty surgery, or additional concurrent surgical procedures.
Preoperative data collection will include demographic variables (age, sex, education level, duration of daily smartphone use). Participants will complete two validated instruments in Turkish: The Smartphone Application-Based Addiction Scale - Turkish Version, The Nomophobia Questionnaire (NMP-Q) - Turkish Version.
Surgical and anesthesia management will follow standardized institutional protocols. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours following surgery. Total analgesic consumption within the first 24 hours will also be recorded.
Participants will be categorized based on their smartphone addiction scores, and postoperative pain outcomes and analgesic consumption will be compared between groups. Additionally, correlation analyses will be performed to explore the association between smartphone addiction levels and perceived postoperative pain.
Sample size was calculated using an effect size derived from a previous study reporting a correlation coefficient of rho = 0.292 between problematic phone use and perceived pain. With a significance level of 0.05 and a statistical power of 80%, a minimum of 91 participants were required. To compensate for an anticipated dropout rate of approximately 10%, the final planned sample size is 100 participants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ali Genç, Assistant professor
- Phone Number: +90-5442280060 +90-3562129500
- Email: aligenc0860@outlook.com
Study Contact Backup
- Name: Muzaffer Katar, Associate Professor
- Phone Number: 0 (356) 212 95 00 - 7515
- Email: Muzaffer.katar@gop.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18-45 years
- Scheduled for elective primary rhinoplasty under general anesthesia
- ASA physical status I-II
- Ability to provide informed consent
Exclusion Criteria:
- History of psychiatric disorders (diagnosed anxiety, depression, bipolar disorder, psychosis)
- Use of chronic analgesic, opioid, sedative, or psychotropic medication
- Previous rhinoplasty or combined surgeries
- Neurological disorders affecting pain perception
- Communication difficulties or inability to complete questionnaires
- Chronic pain syndromes (e.g., fibromyalgia, chronic back pain)
- Intraoperative complications requiring deviation from standard anesthesia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients undergoing elective rhinoplasty
This cohort includes adult patients aged 18-45 years with ASA physical status I-II who are scheduled to undergo elective rhinoplasty under general anesthesia.
All participants will complete preoperative assessments, including demographic data and validated Turkish versions of the Smartphone Application-Based Addiction Scale and the Nomophobia Questionnaire (NMP-Q).
Postoperative pain scores (VAS) will be recorded at 1, 6, 12, and 24 hours following surgery, along with total analgesic consumption within the first 24 hours.
No interventions will be applied as part of the study; the cohort will be observed prospectively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score (VAS)
Time Frame: 1st, 6th, 12th, and 24th postoperative hours.
|
Pain intensity measured using the Visual Analog Scale (0-10)
|
1st, 6th, 12th, and 24th postoperative hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Analgesic Consumption
Time Frame: 24 hours postoperatively
|
The total analgesic consumption within the first 24 postoperative hours, including tramadol administered through patient-controlled analgesia (PCA).
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-MOBAEK-374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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