Anxiety and Hemodynamic Changes in Third Molar Extraction After Patient Education

NCT ID: NCT07018115

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-12-10

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.

Conditions

Dental Anxiety; Hemodynamic; Molar, Third; Tooth Extraction; Tooth Impacted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information.

Group Type: OTHER

Basic Preoperative Information

Intervention Type: OTHER

Participants receive a brief, non-detailed explanation of the surgical procedure.

Articaine 4% with epinephrine 1:100,000

Intervention Type: DRUG

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.

Surgical extraction of impacted mandibular third molar

Intervention Type: PROCEDURE

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.

Multiparameter patient monitor

Intervention Type: DEVICE

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.

Verbal Information Group

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.

Group Type: EXPERIMENTAL

Detailed Verbal Preoperative Information

Intervention Type: OTHER

Participants receive a detailed verbal explanation covering the surgical procedure, including anesthesia, incision, bone removal, tooth sectioning, and suturing.

Articaine 4% with epinephrine 1:100,000

Intervention Type: DRUG

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.

Surgical extraction of impacted mandibular third molar

Intervention Type: PROCEDURE

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.

Multiparameter patient monitor

Intervention Type: DEVICE

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.

Visual Information Group

Participants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure

Group Type: EXPERIMENTAL

Visual Preoperative Information (2D Animation)

Intervention Type: OTHER

Participants receive a 2D animated video illustrating the surgical procedure in addition to the detailed verbal explanation.

Articaine 4% with epinephrine 1:100,000

Intervention Type: DRUG

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.

Surgical extraction of impacted mandibular third molar

Intervention Type: PROCEDURE

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.

Multiparameter patient monitor

Intervention Type: DEVICE

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.

Interventions

Basic Preoperative Information

Participants receive a brief, non-detailed explanation of the surgical procedure.

Intervention Type: OTHER

Detailed Verbal Preoperative Information

Participants receive a detailed verbal explanation covering the surgical procedure, including anesthesia, incision, bone removal, tooth sectioning, and suturing.

Intervention Type: OTHER

Visual Preoperative Information (2D Animation)

Participants receive a 2D animated video illustrating the surgical procedure in addition to the detailed verbal explanation.

Intervention Type: OTHER

Articaine 4% with epinephrine 1:100,000

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.

Intervention Type: DRUG

Surgical extraction of impacted mandibular third molar

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.

Intervention Type: PROCEDURE

Multiparameter patient monitor

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.

Intervention Type: DEVICE

Other Intervention Names

Control Information; Minimal Explanation; Verbal Explanation; Detailed Verbal Education; Verbal Counseling; Animated Video; Visual Education; Animation-Based Information

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ummugulsum Coskun

OTHER

Sponsor Role: lead

Responsible Party

Ummugulsum Coskun

Assistant Professor of Oral and Maxillofacial Surgery, DDS, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ummugulsum Coskun, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Altinbas University

Other Identifiers

2015/30

Identifier Type: -

Identifier Source: org_study_id