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Completed

NCT Number: NCT07484334

Effect of Preoperative Information Videos on Anxiety and Vital Signs in Impacted Third Molar Surgery

This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Participants are assigned to one of three preoperative information methods: standard verbal information, real surgical video information, or 3D animation video information. Changes in systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation are assessed at multiple perioperative time points to determine whether visual information reduces stress-related physiologic responses. The study also examines whether these information methods influence preoperative dental fear.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdogan University Faculty of Dentistry

Rize, Merkez, 53200, Turkey (Türkiye)

About this study

Impacted mandibular third molar surgery is a common oral surgical procedure that is frequently associated with patient stress, fear, and physiologic fluctuations during the perioperative period. In addition to subjective anxiety, these stress responses may be reflected in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation.

This randomized controlled study was designed to investigate whether physician-guided visual information can improve perioperative hemodynamic stability compared with standard verbal information alone. Participants undergoing impacted mandibular third molar surgery are assigned to one of three preoperative information approaches: standard verbal information, real surgical video information, or 3D animation video information.

The primary objective is to compare the effects of these information modalities on perioperative hemodynamic responses measured at predefined time points, including baseline, after local anesthesia, during tooth luxation, after suturing, and during the early recovery period. The secondary objective is to evaluate the effect of these information methods on dental fear using a validated psychometric scale.

The study is based on the hypothesis that visually supported preoperative information, when delivered in a structured and physician-guided manner, may reduce stress-related physiologic fluctuations during surgery and may also influence patients' self-reported dental fear. By comparing verbal, real video, and animation-based information methods, the study aims to clarify whether visual information contributes to better physiologic regulation and patient preparation before third molar surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 50 years
  • ASA physical status I or II
  • Radiographic evidence of an impacted mandibular third molar classified as Pell-Gregory Class I or II and Position A or B
  • Presence of mandibular third molar (tooth 38 or 48) in a vertical or mesioangular position according to Winter's classification
  • Indication for impacted mandibular third molar extraction
  • Willingness to participate and provide written informed consent

Exclusion criteria

  • Active smoking or alcohol consumption
  • Bleeding/coagulation disorders or any systemic disease/medication use that could impair wound healing
  • Pregnancy or lactation
  • Local pathologies associated with the impacted tooth, such as cysts or tumors
  • History of severe anxiety disorder or known psychiatric illness
  • Known allergy to local anesthetics or planned postoperative medications
  • Presence of uncontrolled active periodontal disease
  • Inability or unwillingness to comply with follow-up procedures

Treatment and study plan

Standard Verbal Information

Behavioral

Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.

Real Surgical Video Information

Behavioral

Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.

3D Animation Video Information

Behavioral

Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively

    Systolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).

  2. Change in Diastolic Blood Pressure (DBP)

    Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively

    Diastolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).

  3. Change in Heart Rate (HR)

    Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively

    Heart rate is measured in beats per minute (bpm) to evaluate physiological stress response. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).

  4. Change in Oxygen Saturation (SpO₂)

    Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively

    Peripheral oxygen saturation is measured as a percentage (%) to evaluate respiratory stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4)

Secondary outcomes

  1. Modified Dental Fear Survey (MDFS) Score

    Time frame: Assessed once, immediately after the preoperative information intervention (just prior to surgery)

    Dental fear is assessed using the Modified Dental Fear Survey (MDFS). The survey consists of 20 items, with each item scored on a 5-point Likert scale (from 1 = not at all, to 5 = very much). The total score ranges from a minimum of 20 to a maximum of 100. Higher scores indicate a higher level of dental fear and anxiety, which represents a worse outcome.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

The Effect of Preoperative Surgical Information Videos on Hemodynamic Parameters and Dental Anxiety in Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2026
Registry last updated
May 29, 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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