Clinical trial NCT07018115: Anxiety and Hemodynamic Changes in Third Molar Extraction After Patient Education
Official title: The Effect of Preoperative Patient Information Strategies on Anxiety and Hemodynamic Responses During Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Hemodynamic
Molar, Third
Tooth Extraction
Tooth Impacted
Keywords: Dental Anxiety
Patient Education
Impacted Third Molar
Pain Management
Hemodynamic Changes
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, parallel assignment clinical trial allocates participants into three independent groups to compare the effects of different preoperative patient information strategies (basic explanation, detailed verbal explanation, visual animation) on anxiety levels and physiological responses during third molar extraction. Each group receives only its assigned type of information, and outcomes are measured and compared separately across the groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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:

1. Control group - provided with a brief, basic explanation of the surgical procedure;
2. Verbal information group - provided with a detailed, non-technical verbal explanation covering the anesthesia, surgical steps, and post-operative care;
3. Visual information group - provided with the same verbal explanation plus an educational 2D animation illustrating the surgical process.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Requiring surgical removal of a impacted mandibular third molar
* Ability to read and complete the questionnaires
* Willingness to participate in the study

Exclusion Criteria:

* Age \< 18 years
* History of systemic disease contraindicating surgery
* Poor oral hygiene
* Current pericoronitis or acute infection around the third molar
* Pregnancy

Primary outcomes:
measure: Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery
timeFrame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
measure: Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-Trait) Score After Third Molar Surgery
timeFrame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
measure: Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-State) Score After Third Molar Surgery
timeFrame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Secondary outcomes:
measure: Change in Heart Rate (HR) During Third Molar Surgery
timeFrame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
measure: Change in Systolic Blood Pressure (SBP) During Third Molar Surgery
timeFrame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
measure: Change in Diastolic Blood Pressure (DBP) During Third Molar Surgery
timeFrame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
measure: Change in Peripheral Oxygen Saturation (SpO₂) During Third Molar Surgery
timeFrame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
measure: Pain Intensity During Tooth Extraction Measured by Visual Analog Scale (VAS)
timeFrame: From the start of tooth elevation to immediately after tooth removal (approximately minutes 15 to 20 of the procedure)
measure: Duration of Third Molar Extraction Procedure
timeFrame: From the first surgical incision to the final suture placement (approximately 10 to 30 minutes total)
Other outcomes:
Locations:
Study officials:
affiliation: Altinbas University
name: Ummugulsum Coskun, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: