Non‐Pharmacologic Interventions for Hemodynamic Stability During Dental Implant Surgery: A Randomized Controlled Trial

ABSTRACT

Objectives

To assess the efficacy of non‐pharmacologic interventions, specifically auditory distraction (music or comedy) and haptic distraction (stress‐relief device), in maintaining hemodynamic stability during dental implant surgery.

Material and Methods

This was a prospective, single‐center, randomized trial. We included 150 patients getting single‐tooth implants. Patients were split into three groups of 50. The Control group got standard care. The Auditory Distraction group listened to patient‐selected Guzheng music or Xiangsheng comedy. The Haptic Distraction group used a stress‐relief device. We recorded systolic and diastolic blood pressure and heart rate before and after surgery. We used paired t‐tests and one‐way ANOVA with Tukey's post hoc tests for analysis.

Results

Surgery increased blood pressure in all groups (p < 0.0001). The heart rate response was different between groups. The Control group had a significant increase in heart rate (p < 0.05). Both the Auditory and Haptic Distraction groups had lower heart rates after surgery (p < 0.05). There was no significant difference between the two interventions.

Conclusions

Non‐pharmacologic interventions may not fully prevent the rise in blood pressure from procedure‐related BP elevation. However, these methods help stop the heart rate from rising due to physiological stress. Listening to familiar music or comedy, or using a simple stress‐relief device, can help steady the heart during dental implant surgery.

Clinical Relevance

Auditory and haptic distractions are low‐cost, non‐invasive, and effective adjuncts for managing procedure‐related physiological stress. By stabilizing heart rate, these interventions enhance patient safety and comfort, offering a viable alternative or supplement to pharmacological sedation in implant dentistry.

1. Introduction

Dental implantation has now become the standard treatment for patients with missing teeth [1]. It offers superior functional and esthetic outcomes compared to conventional prosthetics. However, while osseointegration is predictable, the surgical phase remains a significant source of psychological distress for patients. Dental anxiety and fear (DAF) are common and affect a substantial proportion of adults. In implant surgery, which is often seen as invasive and traumatic, anxiety worsens due to the anticipation of pain, the vibration of osteotomy drills, and the visual threat of surgical tools [2].

The clinical effects of intraoperative anxiety go beyond distress. While sudden changes in blood pressure and heart rate represent the autonomic physiological response to surgical stress, they are frequently utilized as indirect proxies for procedure‐related anxiety, though they do not capture the full subjective psychological experience [3]. For implant surgeons, these changes can make bleeding harder to control, obscure the surgical field, and prolong the duration of surgery [4]. In patients with high blood pressure or heart problems, unmanaged stress increases the risk of heart complications [5]. Maintaining steady blood pressure and heart rate is crucial for surgical safety and efficiency.

Pharmacological sedation, including oral anxiolytics (such as benzodiazepines) and intravenous moderate sedation, is commonly used to manage DAF [6]. While effective, these methods present limitations compared to non‐pharmacological approaches. Risks include respiratory depression, drug interactions, and prolonged postoperative recovery [7]. The use of pharmacological sedation also typically requires specialized monitoring equipment and clinician certification, adding complexity and cost. In contrast, non‐pharmacological, behavioral, and sensory interventions are non‐invasive, cost‐effective, and free from systemic side effects, making them attractive alternatives [8].

Non‐pharmacological anxiety management often relies on the “Gate Control Theory” of pain and the “Cognitive Load Theory” [9]. Both suggest that introducing competing auditory or haptic stimuli can make pain and fear less noticeable by occupying the brain's limited sensory‐processing capacity. Music therapy, particularly slow‐tempo, low‐pitch music, has been widely studied and shown to induce parasympathetic dominance [10, 11]. For Chinese patients, traditional pentatonic music, such as Guzheng, offers culturally resonant relaxation. Compared with passive listening, narrative‐based auditory distraction, such as Xiangsheng (traditional comic crosstalk), engages higher‐order cognitive processing and may divert attention more effectively [12]. Haptic distraction, such as stress‐relief devices (e.g., fidget instruments), provides a physical outlet for tension [13]; however, its efficacy in oral surgery has been less explored than that of audiovisual methods.

While previous studies have explored non‐pharmacologic relaxation techniques, such as the recent pilot trial by Mohan et al. demonstrating physiological and biomarker‐level relaxation using yoga, there remains a critical gap in directly comparing culturally tailored auditory narrative processing against standardized haptic distractions during acute surgical phases [14]. Despite promising theories, comparative data on the effectiveness of specific cultural (traditional music), comedic (narrative comedy), and sensory (haptic distraction) interventions during dental implant surgery are limited. Few studies have evaluated the simultaneous hemodynamic impact of each intervention in a controlled surgical setting. This randomized controlled trial aimed to compare the effects of these non‐pharmacological interventions on intraoperative hemodynamic parameters (blood pressure and heart rate) and subjective anxiety levels in dental implant patients. The null hypothesis was that there is no significant difference in hemodynamic stability or anxiety reduction between patients receiving any of these interventions and those receiving standard care.

2. Materials and Methods

2.1. Study Design and Ethical Oversight

This was a prospective, single‐center, parallel‐group, single‐blinded randomized controlled trial (RCT). The study followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The clinical protocol took place at the West China Hospital of Stomatology, Sichuan University. The Institutional Review Board approved the study (Approval No. WCHS‐IRB‐CT‐2025‐598). All procedures were conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. Participants also authorized the collection and analysis of physiological data.

2.2. Participants and Sample Size Determination

A prior sample size calculation was performed with G*Power software (version 3.1.9.7; Heinrich‐Heine‐Universität Düsseldorf, Germany). Pilot data on systolic blood pressure fluctuations during implant surgery suggested an effect size of 0.27. The required sample size for 80% statistical power and an alpha of 0.05 in one‐way ANOVA was 135. A 10% expected attrition increased total enrollment to 150 outpatients. Eligible participants were adults aged 18–65 years, classified as American Society of Anesthesiologists (ASA) physical status I or II, scheduled for uncomplicated single‐tooth implant placement (excluding those needing complex bone augmentation). Exclusion criteria included a diagnosis of hypertension (controlled or uncontrolled), known cardiac conditions, and the current use of any antihypertensive, chronotropic, psychotropic, or sedative medications, as these could confound intraoperative hemodynamic responses. Additional exclusions comprised diagnosed anxiety disorders, hearing impairment preventing music intervention, and acute oral infection at the surgical site.

2.3. Randomization and Blinding

Participants were divided into three groups (n = 50 each) (Figure 1) using a computer‐generated randomization sequence with a block size of 6. This ensured a 1:1:1 allocation. Allocation was concealed with sequentially numbered, opaque, sealed envelopes. These were opened just before surgery. Because of the sensory interventions, neither patients nor surgeons could be blinded. However, the outcome assessor who recorded hemodynamic parameters was blinded to group assignments to reduce bias.

FIGURE 1.

Consort flow diagram illustrating the enrollment, allocation, follow‐up, and final analysis of participants across the Auditory Distraction, Haptic Distraction, and Control groups (n = 50 per group).

2.4. Interventions Group

The Auditory Distraction group participants chose among three tracks reflecting preference and cultural relevance: traditional Chinese Guzheng music (60–80 bpm) or Xiangsheng (comedic crosstalk) (Figure 1). Within the Auditory Distraction group, 31 participants (62%) selected Guzheng music, and 19 participants (38%) selected Xiangsheng comedy. Experimental group interventions started 5 min before anesthesia and ended at suture completion. To ensure strict standardization regardless of individual surgical duration, all selected audio tracks were formatted to play continuously on a seamless loop, preventing any auditory interruption or fluctuation in cognitive distraction during the procedure. Audio was delivered via noise‐canceling headphones to reduce surgical noise. Participants set the volume to a comfortable level for communication. The Haptic Distraction group utilized a standardized, spherical polyurethane foam anti‐stress ball (diameter: 6.3 cm, medium density; Deli Group Co., China). They manipulated the device when tense, for example, during anesthesia. The Control group received standard care in a low‐ambient‐noise environment. Experimental group interventions started 5 min before anesthesia and ended at suture completion.

2.5. Surgical Protocol and Outcome Measures

All surgeries were performed by one experienced operator. Local anesthesia used 4% articaine with 1:100000 epinephrine. Standard flap or flapless protocols were followed for osteotomy and implant placement, as per the manufacturer's instructions. The primary outcomes were systolic and diastolic blood pressure and heart rate (Figure 1). A calibrated electronic blood pressure monitor (Yuwell YE660D, Jiangsu Yuyue Medical Equipment Co. Ltd., Jiangsu, China) recorded outcomes on the non‐dominant arm. Data were collected at two time points: baseline (T0), 10 min after seating and before the intervention; and postoperative (T1), immediately after suturing.

2.6. Statistical Analysis

Data were analyzed with PRISM 9. The Shapiro–Wilk test was used to assess the normality of continuous variables (SBP, DBP, HR). Descriptive statistics were presented as mean ± standard deviation (SD). Baseline demographics were compared by one‐way ANOVA for continuous variables and by Chi‐square for categorical variables. Within‐group hemodynamic changes (Pre vs. Post) were analyzed using paired t‐tests. Intergroup differences at each time were analyzed using one‐way ANOVA with Tukey's post hoc tests. p < 0.05 indicated statistical significance.

3. Results

3.1. Baseline Characteristics and Study Population

A total of 150 eligible participants were enrolled and randomly assigned to the Control, Haptic Distraction, and Auditory Distraction groups (n = 50 per group) (Figure 1). All completed surgery without adverse events. Baseline analysis showed no significant differences in age, sex, or preoperative hemodynamics among groups (p > 0.05), confirming successful randomization. Baseline equivalence was statistically confirmed; one‐way ANOVA revealed no significant differences among the Control, Haptic, and Auditory groups regarding initial SBP (p = 0.74), DBP (p = 0.61), or HR (p = 0.82).

3.2. Hemodynamic Responses: Blood Pressure

The surgery caused a strong stress reaction. This led to a sharp rise in blood pressure across all groups, regardless of the method used. Within each group—from before to right after surgery—systolic blood pressure rose significantly in the Control group (Figure 2a), Haptic Distraction group (Figure 2b), and Auditory Distraction group (Figure 2c) (all p < 0.0001). Diastolic blood pressure also increased in all groups (Figure 3a–c; p < 0.0001). The change in blood pressure (Δ) confirmed these results. The violin plots for both readings (Figures 5a and 4b) mostly show increases across all groups. Overall, non‐pharmacologic approaches did not stop the rise in blood pressure caused by procedure‐related BP elevation and anxiety.

FIGURE 2.

Comparative analysis of preoperative and postoperative systolic blood pressure (SBP) across study groups. Paired scatter plots illustrate individual changes in SBP for (a) the Control group, (b) the Haptic Distraction group, and (c) the Auditory Distraction group. Each line represents a single patient, connecting baseline (Pre) and postoperative (Post) measurements. Regardless of the intervention, a statistically significant elevation in SBP was observed in all three groups (****p < 0.0001).

FIGURE 3.

Comparative analysis of preoperative and postoperative diastolic blood pressure (DBP) across study groups. Paired scatter plots depict the changes in DBP for (a) the Control group, (b) the Haptic Distraction group, and (c) the Auditory Distraction group. A marked and statistically significant increase in diastolic pressure was recorded across all cohorts immediately following the surgical procedure (****p < 0.0001).

FIGURE 5.

Violin plots representing the distribution of hemodynamic changes (Δ values) across groups. (a) Systolic Blood Pressure, (b) Diastolic Blood Pressure, and (c) Heart Rate. The dashed lines represent the median and quartiles. While the Δ distributions for blood pressure (a, b) are shifted positively across all groups (indicating increased pressure), the Δ distribution for Heart Rate (c) highlights a distinct negative shift (deceleration) for the Haptic and Auditory groups compared to the positive shift (acceleration) in the Control groups.

FIGURE 4.

Modulation of heart rate (HR) responses to surgical stress by non‐pharmacological interventions. Paired scatter plots showing HR dynamics for (a) the Control group, (b) the Haptic Distraction group, and (c) the Auditory Distraction group. The Control group exhibited a significant increase in heart rate (*p < 0.05). The Haptic and Auditory Distraction groups demonstrated a statistically significant reduction in heart rate (*p < 0.05).

3.3. Hemodynamic Responses: Heart Rate

In contrast to the uniform elevation in arterial pressure, heart rate responses diverged significantly according to intervention status. This highlights a selective modulation of cardiac chronotropy. The Control group exhibited a statistically significant increase in HR from baseline to the postoperative phase (Figure 4a; p < 0.05), consistent with an unmitigated stress response. Both intervention groups showed a protective effect against intraoperative tachycardia. Participants in the Haptic Distraction group (Figure 4b) and the Auditory Distraction group (Figure 4c) showed a statistically significant decrease in HR from baseline (p < 0.05). The comparative analysis of Δ values (Figure 5c) further illustrates this divergence. The Control group distribution skews toward positive values (acceleration), while both intervention groups show distributions shifted toward negative values (deceleration). One‐way ANOVA of the ΔHR values revealed a significant intergroup difference (F _(2,147) = 14.32, p < 0.001). Tukey's post hoc analysis confirmed that both the Auditory (ΔHR = −4.2 ± 3.1) and Haptic groups (ΔHR = −3.9 ± 3.4) differed significantly from the Control group (ΔHR = +5.1 ± 4.2; p < 0.001), with no significant difference between the two interventions (p = 0.89). This pattern indicates that both auditory and haptic distractions effectively attenuate the cardiac autonomic response. They promote relative parasympathetic dominance, even as vascular resistance increases. An exploratory subgroup analysis within the Auditory Distraction arm revealed no statistically significant difference in HR reduction between patients listening to Guzheng versus Xiangsheng (p = 0.45). However, this comparison was statistically underpowered, and future targeted studies are required to isolate mechanism‐specific auditory effects.

4. Discussion

The present randomized controlled trial evaluated the efficacy of non‐pharmacological behavioral and sensory interventions. Specifically, it examined the effects of culturally relevant auditory distraction and haptic stress relief on intraoperative hemodynamic stability in patients undergoing dental implant surgery. The findings suggest a nuanced rejection of the null hypothesis. The interventions did not inhibit the systemic pressor response. This was evidenced by the universal elevation in systolic and diastolic blood pressure across all groups. However, they did show a significant protective effect on cardiac chronotropy. Both the Auditory (music/narrative) and Haptic (stress toy) groups showed a reduction or stabilization of heart rate. This contrasted sharply with the tachycardia observed in the Control group. This dissociation between vascular resistance and cardiac rate provides critical insights into how the autonomic nervous system is modulated during surgical stress [15].

The universal elevation in blood pressure seen in this study, regardless of intervention, highlights the strong role of the sympathetic‐adrenomedullary axis during invasive procedures [16]. The surgical protocol involved local anesthetic injection and osteotomy drilling. These steps invariably trigger nociceptive signals and activate mechanoreceptors [17, 18]. Such stimuli trigger a reflex release of catecholamines, such as epinephrine and norepinephrine. This leads to peripheral vasoconstriction and a rise in arterial pressure [19]. Our data suggest that while non‐pharmacological interventions can shape psychological appraisal, they may not overcome the strong physiological reflex of sympathetically mediated vasoconstriction caused by acute surgical stimuli. This fits with the limitations of ‘Gate Control Theory’ introduced earlier [20, 21]. Sensory input can dampen nociceptive transmission, but it does not fully block the systemic pressor response from tissue trauma. Furthermore, the universal elevation in blood pressure is heavily confounded by the routine administration of 4% articaine with 1:100000 epinephrine [22]. Epinephrine is a potent exogenous sympathomimetic that induces transient systemic vasoconstriction, independently driving pressor responses regardless of the patient's psychological state or the efficacy of non‐pharmacologic interventions.

In contrast, the significant beneficial effect on heart rate suggests that these interventions modulated vagal tone [23]. The reduction in heart rate in the intervention groups, rather than the acceleration observed in controls, indicates increased parasympathetic activity. While changes in cardiac chronotropy (heart rate) offer a surface‐level indication of autonomic balance, concluding definitive parasympathetic dominance from basic vital signs is limited. Future studies utilizing continuous Heart Rate Variability (HRV) metrics are required to robustly substantiate these autonomic interpretations. The auditory intervention, especially with Guzheng music and Xiangsheng, likely worked through ‘Cognitive Load Theory.’ This theory proposes that engaging higher‐order processing diverts attention from the surgical threat [24]. The result is reduced limbic system signaling to the sinoatrial node. The haptic distraction from the stress‐relief device likely offered a physical outlet for tension. It used motor pathways to reduce acute physiological stress, as seen by better chronotropic stability [25]. This is clinically significant. Tachycardia raises myocardial oxygen demand. Stabilizing heart rate is thus a valuable safety endpoint, even if blood pressure remains high [26].

The similar efficacy of haptic and auditory interventions is notable. Music therapy is well recognized. However, research on simple haptic devices (‘stress toys’) in oral implantology is limited. Our results indicate that giving a patient a device to squeeze during anticipated pain is as effective as sophisticated auditory distraction for managing cardiac stress. This supports the use of affordable, simple haptic interventions in regular practice. It is especially useful where managing audio equipment is difficult.

Despite these positive findings, the study has important limitations. First, hemodynamic parameters were measured only at baseline and immediately after surgery. Continuous intraoperative monitoring might have revealed stress‐induced fluctuations that we missed [27]. Because T1 measurements were taken immediately post‐suturing, the observed heart rate reduction may partially reflect a post‐procedural psychological relief rather than a sustained intraoperative vagal effect. Specifically, critical surgical steps such as local anesthetic administration and osteotomy drilling are known to trigger acute nociceptive reflexes and sudden catecholamine surges [28]. Implementing real‐time, continuous monitoring in future studies would provide a more granular understanding of how these non‐pharmacological interventions perform during peak moments of surgical trauma. Second, the study excluded patients with diagnosed anxiety disorders. However, individual differences in trait anxiety were not stratified, and this may affect how patients respond to non‐pharmacological interventions. By excluding these high‐risk populations, the broad clinical applicability of our findings is limited. Patients with severe, pre‐existing dental anxiety or complex psychiatric histories may possess a heightened sympathetic baseline that cannot be sufficiently modulated by simple auditory or haptic distractions alone, likely necessitating a combined approach using both non‐pharmacological methods and traditional pharmacological sedation [29]. Third, we focused on physiological parameters. These are objective indicators of stress, but future studies should also consider biochemical markers, such as salivary cortisol or alpha‐amylase, to better understand stress‐reduction mechanisms [30]. Furthermore, the reliance on purely physiological data without the inclusion of subjective psychological assessments—such as the Visual Analog Scale (VAS) or the State–Trait Anxiety Inventory (STAI)—limits our ability to fully correlate hemodynamic stability with the patients' perceived psychological relief. Integrating these subjective psychometric tools will be essential in future protocols [31].

5. Conclusion

Within the limitations of this trial, non‐pharmacologic interventions (auditory and haptic) demonstrated a protective effect against procedure‐related tachycardia during single‐tooth implant placement. However, they did not mitigate systemic blood pressure elevations, likely due to exogenous epinephrine and acute surgical nociception. Given the lack of subjective psychometric validation, these low‐cost methods should be viewed as adjunctive physiological stabilizers rather than definitive anxiety treatments.

Author Contributions

Feng Luo drafted the manuscript and participated in the design, coordination, and writing‐review and editing of this study. Zongli Zhang, Qian Mao, Lin Luo, and Yin participated in the design and coordination of this study. All authors read and approved the final manuscript.

Funding

The authors have nothing to report.

Ethics Statement

The study adhered to the ethical standards outlined in the Declaration of Helsinki and approved by the Academic Affairs Office of West China School of Stomatology, Sichuan University (WCHS‐IRB‐CT‐2025‐598). All the steps/methods were performed in accordance with the relevant guidelines and regulations.

Consent

Informed consent was acquired from all respondents.

Conflicts of Interest

The authors declare no conflicts of interest.

Data Availability Statement

All data supporting the findings of this study are available within the paper.