- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07679659
Effect of a Preoperative Educational Video on Anxiety Levels (PEVA)
Effect of QR Code-Based and Tablet-Based Preoperative Educational Video Interventions on Preoperative Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative anxiety is associated with adverse psychological and physiological responses and may negatively influence the perioperative experience. Educational interventions have been proposed as a practical strategy to improve patient understanding and reduce anxiety before surgery. Video-based education offers a standardized and accessible method for delivering information regarding anesthesia and surgical procedures.
Recent advances in digital health technologies have facilitated the use of mobile devices and QR code-based educational tools in routine clinical practice. However, evidence regarding the effectiveness of different modes of video delivery on preoperative anxiety remains limited.
This study will evaluate whether a brief educational video delivered through a QR code before the day of surgery or viewed on a tablet device immediately before surgery can reduce preoperative anxiety compared with standard care. In addition, the study will assess the feasibility and utilization of QR code-based patient education in the perioperative setting. The findings may contribute to the development of accessible and scalable patient education strategies aimed at improving the surgical experience and patient-centered care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gülencan Yumuşak Ergin, MD
- Phone Number: +905373587055
- Email: gulencanyumusak@gmail.com
Study Contact Backup
- Name: Tuğba Açıkgöz
- Phone Number: +905334318062
- Email: gulencanyumusak@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older.
- Scheduled for elective surgery under anesthesia.
- Able to understand Turkish.
- Able to provide written informed consent.
Exclusion Criteria:
- Emergency surgery.
- Visual or hearing impairment preventing video viewing.
- Cognitive impairment.
- Neurological or psychiatric disorders that may interfere with communication or completion of study questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: QR Code Video Group
Participants will receive a QR code during the preoperative anesthesia clinic visit, allowing access to a brief educational video about anesthesia and surgery.
Participants may view the video on their own devices before the day of surgery.
|
Participants received a QR code providing access to the standardized preoperative educational video.
They were instructed to watch the video before surgery using their own smartphone or another internet-enabled device.
|
|
Experimental: Tablet Video Group
Participants will watch the same educational video on a tablet device in the preoperative waiting area immediately before surgery.
|
Participants viewed the standardized preoperative educational video on a tablet device provided by the study staff in the preoperative waiting area before surgery.
|
|
No Intervention: Control Group
Participants will receive standard preoperative information and routine care without exposure to the educational video.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amsterdam Preoperative Anxiety and Information Scale ( APAIS)
Time Frame: On the day of surgery, immediately before induction of anesthesia
|
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be used to assess preoperative anxiety and information requirement.
Scores range from 6 to 26, with higher scores indicating greater preoperative anxiety and information requirement (worse outcome).
|
On the day of surgery, immediately before induction of anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QR Code Utilization Rate
Time Frame: From enrollment until immediately before anesthesia induction on the day of surgery, assessed up to 1 month
|
The proportion of participants who accessed the educational video through the provided QR code before surgery.
|
From enrollment until immediately before anesthesia induction on the day of surgery, assessed up to 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gülencan Yumuşak Ergin, MD, Aksaray University Training and Research Hospital
Publications and helpful links
General Publications
- Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
- Cetinkaya F, Kavuran E, Unal Aslan KS. Validity and reliability of the Amsterdam Preoperative Anxiety and Information Scale in the Turkish population. Turk J Med Sci. 2019 Feb 11;49(1):178-183. doi: 10.3906/sag-1806-84.
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
- SAGETİK 2026-82
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
University of Colorado, BoulderEnrolling by invitationStress | Anxiety | Social AnxietyUnited States
Clinical Trials on QR Code Video
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruitingAnxiety | Health Education | Family Members of Intensive Care Unit PatientsTurkey (Türkiye)
-
Acibadem UniversityCompletedQuality of Life | Infertility | In Vitro Fertilization | Health Education | Psychosocial Support SystemsTurkey (Türkiye)
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruitingPreoperative Anxiety | Anesthesia | Informed Consent | Patient EducationTurkey (Türkiye)
-
Istituto per la Ricerca e l'Innovazione BiomedicaMessina, ItalyRecruitingAutism Spectrum Disorder | AutismItaly
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiEnrolling by invitationNursing Education | Nursing Students | Clinical Practice | Evidence Based NursingTurkey
-
Karabuk UniversityNot yet recruitingPreoperative Anxiety | Postpartum Pain | Maternal Comfort | Cesarean Birth
-
Ankara Yildirim Beyazıt UniversityEnrolling by invitationPatient Satisfaction | Thyroidectomy | Discharge EducationTurkey (Türkiye)
-
Kocaeli UniversityCompletedEducation | Mother-Infant Interaction | Nursing CareTurkey
-
Mayo ClinicCompletedCritical IllnessUnited States
-
Sakarya UniversityNot yet recruiting