An interventional study of Basic Preoperative Information and Detailed Verbal Preoperative Information in Dental Anxiety, Hemodynamic and Molar, Third, sponsored by Ummugulsum Coskun. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Ummugulsum Coskun · Not applicable, Interventional, and Supportive care
This randomized clinical trial investigates the effect of different preoperative patient information strategies on anxiety levels and hemodynamic responses during third molar extraction. Ninety-seven patients were assigned to control, verbal information, or visual (animation) information groups. Anxiety was measured using the Modified Dental Anxiety Scale (MDAS) and State-Trait Anxiety Inventory (STAI), while heart rate, blood pressure, oxygen saturation, and pain were recorded. The study aims to assess whether educational interventions can reduce anxiety and improve patient comfort during oral surgery.
This prospective, randomized clinical trial was designed to evaluate the effect of different preoperative patient information strategies on anxiety levels, hemodynamic responses, and pain perception during the surgical extraction of impacted mandibular third molars. Third molar extraction is a common procedure in oral and maxillofacial surgery, often associated with elevated patient anxiety, which can negatively affect both psychological well-being and physiological parameters such as heart rate and blood pressure.
In this study, 97 patients requiring surgical removal of a single impacted mandibular third molar were recruited and randomly assigned into one of three groups:
The anxiety levels of participants were measured using two validated scales: the Modified Dental Anxiety Scale (MDAS) and the State-Trait Anxiety Inventory (STAI), both before and after surgery. Physiological measurements, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SaO₂), were recorded at five standardized time points: before surgery, after information delivery and before anesthesia, after anesthesia, during tooth extraction, and in the postoperative period. Pain levels were assessed during the procedure using a Visual Analog Scale (VAS).
All surgeries were conducted under local anesthesia by experienced oral surgeons, following a standardized surgical protocol to minimize operator-related variability. The study also considered demographic and clinical variables, such as patient age, sex, education level, and the depth of impaction of the third molar, as potential factors influencing anxiety and physiological responses.
The study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University, and received approval from the university's ethics committee (approval number 2015/30). The primary hypothesis was that providing patients with detailed verbal or visual information would reduce preoperative anxiety compared to basic explanations, and that visual tools might offer additional benefits by enhancing patient understanding and comfort.
The results demonstrated that while anxiety scores generally decreased postoperatively across all groups, the visual (animation) information group showed significantly better oxygen saturation levels during extraction and in the postoperative period, suggesting a positive physiological impact. However, no significant differences were found between groups regarding pain scores or overall surgical duration.
These findings highlight the importance of preoperative patient education and suggest that incorporating visual educational tools, such as animations, may improve physiological stability and patient experience during oral surgical procedures. Further research is warranted to refine these strategies and explore their long-term benefits in various dental and surgical contexts.
Exclusion Criteria:
Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information.
Other: Basic Preoperative Information · Drug: Articaine 4% with epinephrine 1:100,000 · Procedure: Surgical extraction of impacted mandibular third molar · Device: Multiparameter patient monitor
Participants receive a comprehensive verbal explanation of the surgical procedure, covering all key steps such as anesthesia, incision, bone removal, tooth sectioning, and suturing, delivered in clear, non-technical language to optimize patient understanding.
Other: Detailed Verbal Preoperative Information · Drug: Articaine 4% with epinephrine 1:100,000 · Procedure: Surgical extraction of impacted mandibular third molar · Device: Multiparameter patient monitor
Participants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure
Other: Visual Preoperative Information (2D Animation) · Drug: Articaine 4% with epinephrine 1:100,000 · Procedure: Surgical extraction of impacted mandibular third molar · Device: Multiparameter patient monitor
Participants receive a brief, non-detailed explanation of the surgical procedure.
Also known as: Control Information; Minimal Explanation
Participants receive a detailed verbal explanation covering the surgical procedure, including anesthesia, incision, bone removal, tooth sectioning, and suturing.
Also known as: Verbal Explanation; Detailed Verbal Education; Verbal Counseling
Participants receive a 2D animated video illustrating the surgical procedure in addition to the detailed verbal explanation.
Also known as: Animated Video; Visual Education; Animation-Based Information
A local anesthetic solution (Ultracain D-S; Aventis) administered in a dose of 2 ml for all patients. The anesthetic was injected to achieve regional nerve block anesthesia (inferior alveolar, lingual, and buccal nerves) prior to the surgical extraction of impacted mandibular third molars. The solution contains epinephrine as a vasoconstrictor to prolong anesthetic effect and minimize intraoperative bleeding.
A standardized surgical protocol was followed for the removal of impacted mandibular third molars. All procedures were performed under local anesthesia using a mucoperiosteal flap approach. The surgery included a linear or triangular incision, elevation of the mucoperiosteal flap, ostectomy using rotary instruments as needed, and tooth sectioning in cases of difficult extraction. The socket was irrigated with sterile saline solution, and hemostasis was achieved. Wound closure was performed with 4.0 silk sutures. All surgeries were conducted by experienced oral and maxillofacial surgeons without sedation or premedication. The entire procedure was monitored for hemodynamic parameters including heart rate, blood pressure, and oxygen saturation.
A hospital-grade multiparameter monitor was used to measure and record patients' vital signs at five defined surgical stages: before surgery, after information delivery, after local anesthesia, during tooth extraction, and postoperatively. The monitor continuously recorded heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), and peripheral oxygen saturation (SpO₂). The collected data were used to evaluate physiological responses associated with anxiety and surgical stress.
Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery
The Modified Dental Anxiety Scale (MDAS) is a validated questionnaire consisting of 5 items, each scored from 1 (not anxious) to 5 (extremely anxious), producing a total score range of 5 to 25. Higher scores indicate higher levels of dental anxiety. In this study, participants completed the MDAS before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in MDAS score from baseline to postoperative was calculated to assess the effect of patient education interventions on dental anxiety levels.
Time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-Trait) Score After Third Molar Surgery
The Spielberger State-Trait Anxiety Inventory - Trait (STAI-T) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (almost never) to 4 (almost always), giving a total score between 20 and 80. Higher scores indicate higher levels of trait anxiety. In this study, participants completed the STAI-T before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-Trait score from baseline to postoperative was calculated to assess the effect of patient education on trait anxiety.
Time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-State) Score After Third Molar Surgery
The Spielberger State-Trait Anxiety Inventory - State (STAI-S) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (not at all) to 4 (very much so), giving a total score between 20 and 80. Higher scores indicate higher levels of state anxiety. In this study, participants completed the STAI-S before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-State score from baseline to postoperative was calculated to assess the effect of patient education on state anxiety.
Time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Change in Heart Rate (HR) During Third Molar Surgery
Heart rate was measured in beats per minute (bpm) at five predefined time points: T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. Changes in heart rate across these phases were analyzed to evaluate the physiological impact of surgical stress and preoperative patient information.
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Systolic Blood Pressure (SBP) During Third Molar Surgery
Systolic blood pressure (SBP) was measured at five predefined time points: T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. Changes in SBP were analyzed to assess physiological responses to preoperative patient education and surgical stress.
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Diastolic Blood Pressure (DBP) During Third Molar Surgery
Diastolic blood pressure (DBP) was measured in mmHg at five predefined time points: T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. These measurements were used to assess physiological stress responses during third molar surgery and the potential influence of preoperative patient education.
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Peripheral Oxygen Saturation (SpO₂) During Third Molar Surgery
Peripheral oxygen saturation (SpO₂) was measured as a percentage (%) at five predefined time points: T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. These measurements were analyzed to identify potential changes in oxygen saturation associated with surgical stress and the impact of different patient education methods.
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Pain Intensity During Tooth Extraction Measured by Visual Analog Scale (VAS)
Pain was assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Patients were asked to report their pain level immediately after the tooth was extracted, while still in the surgical setting. This measure reflects the intensity of pain experienced specifically at the moment of tooth removal and was used to evaluate its relationship with the type of preoperative patient education provided.
Time frame: From the start of tooth elevation to immediately after tooth removal (approximately minutes 15 to 20 of the procedure)
Duration of Third Molar Extraction Procedure
The duration of the surgical procedure was recorded in minutes, starting with the first incision and ending with the placement of the final suture. This variable was used to evaluate whether the type of preoperative patient education influenced the total procedure time or surgical efficiency.
Time frame: From the first surgical incision to the final suture placement (approximately 10 to 30 minutes total)
No study locations are listed for this record.
Plan to share: Yes — Individual participant data (IPD) will be made available to qualified researchers upon reasonable request after publication of the study results.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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