Effectiveness of emotional freedom techniques in patients with persistent postural-perceptual dizziness: study protocol for a multicenter, pragmatic, pilot randomized controlled trial

Introduction

The concept of chronic dizziness was first introduced in the 1980s by Brandt and Dieterich (1), who proposed the term phobic postural vertigo. In the early 2000s, Staab et al. (2) redefined and expanded the concept as chronic subjective dizziness. To standardize definitions, the Bárány Society subsequently integrated these concepts and proposed persistent postural-perceptual dizziness (PPPD) as a unified vestibular disorder in 2010 and 2014, which was later incorporated into the World Health Organization’s International Classification of Diseases (ICD-11) in 2015 (3). PPPD arises from the complex interplay of vestibular disorders, medical or neurological conditions, and psychological stress (4). As a chronic disorder, it substantially impairs patients’ quality of life and is frequently associated with psychiatric and somatic symptoms such as anxiety, depression, insomnia, and fatigue. These features highlight the importance of comprehensive symptom management and supportive care that extend beyond vestibular dysfunction alone.

Emotional freedom techniques (EFT), developed by Gary Craig in 1995, is a mind-body intervention that combines somatosensory stimulation of acupuncture points with cognitive-emotional processing (5,6). By reducing physiological arousal and emotional responses to stress and traumatic memories, EFT is thought to modulate autonomic nervous system activity and enhance psychological resilience (7). Recent randomized controlled trials (RCTs) and meta-analyses have demonstrated the efficacy of EFT in reducing symptoms of post-traumatic stress disorder (PTSD), with sustained effects at follow-up (8). Given its effectiveness in PTSD and its applicability to disorders characterized by emotional dysregulation, EFT may represent a supportive or adjunctive intervention for PPPD, particularly in addressing the emotional dysregulation and quality-of-life burden associated with the condition (9).

Cognitive behavioral therapy (CBT) remains the most commonly recommended intervention for the neuropsychiatric aspects of PPPD (10); however, its clinical application is limited due to the shortage of trained professionals, high time and cost burden. EFT, which shares similar therapeutic principles, may provide an alternative or complementary option.

In addition, conventional Korean medicine treatments (e.g., acupuncture and herbal medicine) have been widely applied in the management of dizziness and have demonstrated both symptom-relieving effects and favorable safety profiles. However, no RCT to date has evaluated the combined use of EFT and Korean medicine treatments in patients with PPPD.

Therefore, this study aims to conduct a pragmatic RCT to evaluate the effectiveness and safety of EFT in reducing symptom burden, improving neuropsychological functioning, and enhancing quality of life in patients with PPPD. We present this article in accordance with the SPIRIT reporting checklist (available at https://apm.amegroups.com/article/view/10.21037/apm-25-87/rc).

Methods

Study aims

The objective of this study is to evaluate the clinical effectiveness and safety of EFT in patients with PPPD. To facilitate the design and implementation of future large-scale clinical trials, data will be systematically collected and analyzed within a pragmatic RCT setting. Specifically, this pilot trial aims to assess the feasibility and preliminary effectiveness of EFT in reducing dizziness-related disability and associated symptoms. Safety will also be evaluated by monitoring and comparing adverse events to identify potential harms.

Study design

This study is designed as a multicenter, pragmatic RCT. A total of 30 patients diagnosed with PPPD will be recruited from four Korean medical institutions in South Korea between August 1, 2024, and December 31, 2026 (Figure 1). Eligible participants who meet the inclusion criteria and provide informed consent will undergo a screening process, after which they will be randomly assigned in a 1:1 ratio to either the experimental group (receiving conventional treatment in Korean medicine in combination with EFT) or the control group (receiving conventional treatment in Korean medicine only). Written informed consent will be obtained from all participants by qualified investigators after verbal and written explanation of the study and confirmation of voluntary participation. To maintain objectivity in data analysis, the statistician will be blinded to group allocation throughout the study.

Figure 1 Schematic chart of the study. EFT, emotional freedom techniques.

Participants will be enrolled at four sites, and the clinical trial will be conducted in outpatient settings: Kyung Hee University Korean Medicine Hospital, Kyung Hee Kwon Clinic, Kyung Hee Osundosun Clinic, and Dong-Eui University Korean Medicine Hospital. The two affiliated clinics are part of Kyung Hee University Korean Medicine Hospital, and the two primary institutions for this study are Kyung Hee University Korean Medicine Hospital and Dong-Eui University Korean Medicine Hospital. All participating sites are Korean medicine hospitals or clinics with outpatient facilities and clinical research experience. EFT will be provided by licensed Korean medicine doctors trained in the intervention, and conventional treatment will be delivered by qualified clinicians at each site. The coordinating site will be Kyung Hee University Korean Medicine Hospital, which will oversee overall trial management, protocol adherence, and inter-site communication. A steering committee, consisting of the principal investigators from all participating centers, will provide strategic oversight and resolve protocol-related issues.

Trial registration and study timeline

This trial was prospectively registered with the Clinical Research Information Service (CRIS), Korea (KCT0010114), on December 9, 2024 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28816&search_page=L&search_lang=&class_yn=). The current manuscript corresponds to protocol version 1.0 (December 2024), and the complete registration record is available through the CRIS website. The study commenced on October 21, 2024, following institutional review board approval, and is scheduled for completion on June 30, 2026. The timeline encompasses participant recruitment, delivery of the intervention, follow-up assessments, and the subsequent data analysis phase.

Randomization and blinding

To ensure allocation concealment and prevent bias, randomization will be conducted by an independent statistician using SAS^® (Statistical Analysis System) PROC PLAN or R (ver. 4.4.1). Randomization numbers will be generated sequentially using block randomization (block size =4), stratified by site, sex, and age.

Each participant who provides informed consent will be assigned a screening number (format: S-[site code]-[XX]) based on the order of consent. Eligible participants will be randomized in the order of registration, regardless of screening number, and assigned a randomization code (R-[site code]-[XX] or R-C-[XX] for central allocation). Random allocation sequences will be generated by an independent third party. Allocation concealment will be ensured by withholding group assignment from investigators until after participant enrollment. Assignment information will be communicated to site investigators only after enrollment, via text message. An encrypted, access-controlled online spreadsheet will be used to share real-time screening and enrollment status among sites. Once assigned, randomization codes cannot be reused, even if a participant withdraws consent.

In this pragmatic clinical trial, both practitioners and participants will be unblinded to treatment allocation, as the study follows an open-label design. In contrast, statisticians will remain blinded to group assignments to ensure objectivity in data interpretation. The final analysis will also be blinded to group allocation. Blinding of analysts will be achieved by providing data with coded group labels (e.g., Group A vs. Group B) rather than actual treatment allocation. Group codes will only be revealed after the completion of the primary analysis.

Participants

This study targets adult patients diagnosed with PPPD. Recruitment will be conducted via on-site and online announcements, including postings on the hospital website. Additionally, the study will be promoted to patients visiting relevant departments, and text messages will be sent to existing patients who have consented to receive such messages and to the use of their personal information. The message will include details such as the study title, objectives, methods, eligibility criteria, and possible adverse effects. Patients may opt out of receiving messages at any time, and message receipt will not affect study participation.

Diagnostic criteria for PPPD

The PPPD was established by the Committee for the Classification of Vestibular Disorders of the Bárány Society (4) (Table 1).

Inclusion criteria

• Adults aged 19 years or older and under 65 years;
• Patients who meet the diagnostic criteria for PPPD and report dizziness with a Dizziness Handicap Inventory (DHI) score of 16 or higher:
  • Persistent non-rotational dizziness lasting for more than three months;
  • Heightened sensitivity to self-motion or environmental motion persisting for more than three months;
  • Worsening symptoms in complex visual environments or during visually demanding tasks such as reading or computer use.
• Individuals who have signed a written informed consent form.

Exclusion criteria

• Individuals diagnosed with abnormalities based on neuro-otological examinations or brain imaging studies.
• Patients experiencing dizziness associated with neck pain or stiffness, particularly when related to cervical movement or posture.
• Individuals diagnosed with dizziness caused by cardiovascular diseases: e.g., arrhythmia, heart valve disease, anemia, orthostatic hypotension, and coronary artery disease.
• Individuals diagnosed with severe chronic or terminal illnesses: e.g., malignant tumors, chronic renal failure, tuberculosis.
• Individuals diagnosed with dizziness due to active or uncontrolled diseases: e.g., uncontrolled diabetes, hypertension, other respiratory or endocrine disorders.
• Individuals diagnosed with dizziness caused by current medication use.
• Individuals suspected of alcohol or substance abuse.
• Pregnant or breastfeeding individuals, or those planning to become pregnant during the study period.
• Individuals who have participated in another clinical trial within one month prior to the start of the intervention.
• Individuals with communication impairments may prevent them from following study instructions.
• Any other individuals deemed unsuitable for participation by the principal investigator or study staff.

Sample size estimation

Due to the lack of prior research on the effects of EFT on PPPD, it is not possible to estimate the effect size in advance. In accordance with established guidelines for exploratory studies, a sample size of 15 participants per group was selected. According to expert opinion, for a target power of 90% and a standardized effect size (d) of 0.3≤ d <0.7, a pilot study requires 15 participants per group. The subsequent main trial may require 44 to 235 participants per group. This pilot study is expected to provide preliminary estimates necessary for conducting a power analysis for the main trial (11).

Interventions

For the experimental group, in addition to 8 sessions of EFT (1–3 times per week), the number of visits and schedule will be the same as those of the control group (Table 2).

The experimental group will receive conventional Korean medical care combined with adjunctive EFT, whereas the control group will receive conventional treatment alone. This comparator was chosen because it allows us to evaluate the therapeutic effect of Korean medicine treatment alone, while also reflecting the real-world clinical situation in which patients often receive only conventional Korean medicine care. In addition, this design enables us to determine the additive effect of EFT beyond routine Korean medicine practice.

Stable doses of medications for dizziness, anxiety, or depression started ≥4 weeks before enrollment will be permitted, along with routine medical care. Other psychotherapies (e.g., CBT, mindfulness), EFT outside the trial, or initiation of new treatments for dizziness or psychiatric disorders will be prohibited during the study.

EFT

The EFT is a meridian-based psychotherapeutic approach rooted in the integrative field of energy psychology (EP). It combines elements of CBT, exposure therapy, and somatic stimulation of facial and acupressure points (12).

EFT utilizes 15 specific acupuncture points, selected primarily from areas that are easy to tap, such as the face, hands, and upper body. These points were chosen to activate the entire meridian system by targeting either the starting or terminal point of each corresponding meridian. The selected acupuncture points for each meridian are as follows: GV20 (Baihui), BL2 (Zanzhu), GB1 (Tongziliao), ST1 (Chengqi), GV26 (Renzhong), CV24 (Chengjiang), KI27 (Shufu), SP21 (Dabao), LU11 (Shaoshang), LI1 (Shangyang), PC9 (Zhongchong), HT9 (Shaochong), SI3 (Houxi) (12).

The EFT intervention was administered in accordance with a standardized 7-step protocol, integrating cognitive affirmation and acupoint stimulation (7,12,13) (Table 3).

This clinical trial is an experimental study designed to compare and evaluate the effectiveness of a combined therapy of EFT and conventional treatment in Korean medicine with conventional treatment alone. Both the control group and the treatment group receive conventional treatment in Korean medicine, but the treatment group will additionally receive EFT. The clinical investigator will instruct patients on the EFT method and distribute a manual at the outpatient clinic to practice independently. Participants will be instructed to record their home-based EFT practice using a structured log that includes session frequency, duration, and perceived difficulty. The study clinicians will review these logs at each follow-up visit to assess adherence and identify potential obstacles to practice. In addition, participants will receive brief weekly check-ins via phone or text message to encourage continued engagement and verify ongoing practice. This approach is intended to support treatment fidelity and capture the feasibility of implementing EFT outside the clinical setting.

Conventional treatment in Korean medicine

The conventional treatment was structured according to the “Dizziness Clinical Practice Guideline of Korean Medicine (14)” and consisted of standardized interventions aimed at enhancing vestibular function. Specifically, the treatment aimed to enhance vestibular function by supporting somatosensory and visual compensation through acupuncture, and to restore systemic vitality compromised by chronic symptoms through individualized herbal medicine. Acupuncture targeted the vestibulocervical reflex using acupoints located on the head and neck, including GB20 (Fengchi), GV20 (Baihui), and EX-HN5 (Taiyang), and the vestibulospinal reflex using spinal and lower limb points such as ST36 (Zusanli), GB34 (Yanglingquan), and KI3 (Taixi). Herbal treatment included representative formulas commonly prescribed for general tonification, such as Banha Baekchul Cheonma-Tang and Bojungikgi-Tang. Additionally, other traditional therapies such as moxibustion and cupping may be applied as needed, depending on the patient’s condition.

Although CBT and vestibular rehabilitation are internationally recognized treatments for PPPD, their availability in Korea remains limited due to barriers in accessibility and specialist training. In a national survey of Korean physical therapists, 75.6% reported having no prior education in vestibular rehabilitation, indicating substantial gaps in professional training and dissemination (15). These findings suggest that the clinical implementation of vestibular rehabilitation in Korea may be constrained by workforce and educational limitations. Therefore, using Korean medicine as the comparator provides a pragmatic and contextually relevant benchmark that reflects the actual treatment landscape in Korean clinical practice.

Outcomes

Studies incorporating the following outcome domains will be considered eligible for inclusion in this protocol:

• Symptom-related functional impairment: DHI;
• Emotional and psychological well-being: Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Insomnia Severity Index (ISI);
• Health-related quality of life and global functioning: EuroQol 5-Dimension 5-Level (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), Modified Clinical Global Impression-Improvement for Sasang Constitutional Symptomatology (mCGI-I for SCS).

The clinical outcomes of this study will be assessed at Visit 2 (treatment initiation) and Visit 9 (completion), with the primary comparison being the difference between baseline Visit 2 and Visit 9.

Safety and adverse events

Adverse events will be assessed at every visit from Visit 2 (treatment initiation) to Visit 9 (completion). The investigator will document all adverse events that occur during the clinical study. Adverse events will be evaluated by the investigator and recorded with details including event name, onset date, resolution date, severity, causality, actions taken, and outcome. Throughout the study period, the principal investigator and study staff must ensure the safety of participants. Since this trial involves low-risk interventions, no ancillary care is planned. However, participants experiencing study-related harm will receive appropriate medical care and compensation according to institutional policies.

Data collection

All patient information collected during the clinical trial will be accurately and truthfully recorded by specially trained investigators. This study will utilize the public electronic case report forms (eCRF) system “iCLICK”, provided by the National Development Institute of Korean Medicine. The iCLICK website is a National Evidence-based Healthcare Collaborating Agency (NECA)-operated platform for clinical practice guideline development and dissemination. A compliance report will be prepared and submitted together with the data management plan at the time of activating the iCLICK study page (ongoing status, subject enrollment). Personal information of participants will be strictly confidential, and all data will be recorded using anonymized code numbers. No researcher will be granted access to the data without prior approval from the principal investigator. In accordance with good clinical practice, all patient data will be retained in the database for five years following the completion of the trial.

To promote participant retention, detailed study information, regular reminders, and coordinator support will be provided. Participants who discontinue the intervention or deviate from the protocol will not undergo further data collection. However, data obtained prior to discontinuation will be included in the analysis.

Adherence and monitoring

In the EFT group, participants will be encouraged to practice EFT techniques at home, and fidelity will be monitored by trained clinicians under regular supervision. In the control group, details of conventional Korean medicine treatment will be recorded in the eCRF, and adherence to routine practice will be monitored. All adherence-related data will be reviewed regularly by the coordinating site through the iCLICK system.

Trial conduct will be monitored by the study coordinator under the supervision of the principal investigator, with quarterly central review of the iCLICK eCRF and on-site visits as needed. Procedures will include verification of informed consent, source data validation, protocol adherence, and review of adverse event reporting, with findings reported to the principal investigator and the institutional review board. Given the small sample size and low-risk nature of this pilot trial, no formal data monitoring committee will be established, and no interim analyses or stopping guidelines are planned. All important protocol modifications will be submitted to the institutional review board for approval and communicated to investigators, participants, if applicable, and updated in the trial registry.

Statistical analysis

The primary outcome for the effectiveness assessment in this study is the difference in DHI scores from baseline Visit 2 to Visit 9. Secondary outcomes include changes in the BDI-II, BAI, ISI, EQ-5D-5L & EQ-VAS, and mCGI-I for SCS.

Effectiveness analysis will primarily be conducted on the full analysis set, which includes all randomised participants who received at least one session of intervention, analysed according to their randomised group (intention-to-treat principle). A supplementary analysis will be conducted using the per-protocol set, consisting of participants who adhered fully to the protocol without major deviations. Safety analysis will be performed on the safety analysis set, which includes all participants who received at least one intervention session, analysed according to the intervention actually received. Missing data will be handled using the last observation carried forward method. Continuous variables will be compared between groups using either a two-sample t-test or the Wilcoxon rank-sum test, as appropriate. For repeated measures, within-group comparisons before and after the intervention will be performed using a paired t-test or the Wilcoxon signed-rank test. Categorical variables will be analyzed using the Chi-squared test or Fisher’s exact test, depending on data distribution. All statistical tests will be two-sided with a significance level set at 0.05. Baseline demographic and clinical variables showing significant intergroup differences will be included as covariates in the effectiveness analysis. A feasibility study will be undertaken to assess the practicality of trial implementation. The feasibility of participant recruitment will be evaluated via dropout rates, while protocol adherence will be assessed by analyzing time-related biases in adverse events. Data quality and completeness will be evaluated based on the integrity of outcome measures. Between-group comparisons will inform the appropriateness of the study design and methodology, and safety endpoints will be reviewed to assess safety and ethical considerations. Exploratory subgroup and sensitivity analyses will also be conducted to assess the robustness and generalizability of the findings.

Findings from this pilot study will provide essential information for designing a subsequent full-scale RCT. Preliminary effect size estimates for key outcomes, together with recruitment and retention rates, adherence patterns, and the variability of outcome measures, will inform sample-size calculations and the selection of primary endpoints. Feasibility indicators and operational feedback will also guide refinements to eligibility criteria, intervention procedures, and study logistics for the definitive trial.

Ethical statement

Prior to any study procedures, participants were provided with written information to ensure voluntary participation, and written informed consent was obtained, with copies given to participants and originals retained at the study site. Before the initiation of the study, the protocol, consent forms, recruitment materials, and related documents were submitted to the institutional ethics committee and received approval. The study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study protocol received approval from the Institutional Review Board of Kyung Hee University Korean Medicine Hospital (No. KOMCIRB 2024-08-003-003).

Discussion

We conducted a multicenter RCT to explore the clinical effectiveness and feasibility of EFT in patients with PPPD. Patient-reported outcomes, including the DHI, BAI, BDI-II, ISI, EQ-5D-5L, and mCGI-I, were used to assess treatment effects with validated instruments. Although the pragmatic design may reflect variability in routine clinical practice, we mitigated this limitation by implementing standardized acupuncture and herbal medicine protocols across sites.

PPPD is not directly life-threatening, but it represents a chronic disorder that imposes a substantial burden on patients’ lives. Persistent dizziness and visual-postural instability severely restrict daily functioning, social participation, and occupational performance (16). In addition, chronic fatigue, insomnia, anxiety, and depression are common, and over time these symptoms may progress to major depressive disorder, anxiety disorders, and maladaptive fear-avoidance behaviors. Patients frequently seek care across multiple specialties—including neurology, otolaryngology, and psychiatry—resulting in significant medical and economic burden (17). Some PPPD patients exhibit central sensitization, which is associated with more severe dizziness-related disability as well as higher levels of anxiety and depression, thereby complicating management (18). These features highlight PPPD as a serious disorder in terms of quality-of-life impairment and healthcare utilization, underscoring the need for supportive and integrative therapeutic strategies.

Zheng et al. (19) reported that EFT mitigates neuropsychological symptoms associated with emotional dysregulation, including anxiety and depression, and is also associated with improvements in sleep quality. The present study similarly examined the safety and effectiveness of EFT in a real-world clinical environment, thereby exploring its potential scalability and dissemination. Nonetheless, as a pilot trial, this study is limited by a small sample size and inter-institutional heterogeneity. Future research should build upon the effect sizes and feasibility findings presented here to calculate sample sizes and design confirmatory clinical trials.

In conclusion, this study provides preliminary evidence supporting emotion-focused integrative treatment approaches for PPPD and may contribute to expanding safe, non-pharmacological therapeutic options aimed at reducing symptom burden and improving quality of life.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the SPIRIT reporting checklist. Available at https://apm.amegroups.com/article/view/10.21037/apm-25-87/rc

Peer Review File: Available at https://apm.amegroups.com/article/view/10.21037/apm-25-87/prf

Funding: This work was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant No. RS-2024-00441603).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://apm.amegroups.com/article/view/10.21037/apm-25-87/coif). All authors report that the authors received a grant from the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study protocol received approval from the Institutional Review Board of Kyung Hee University Korean Medicine Hospital (No. KOMCIRB 2024-08-003-003). Prior to any study procedures, participants were provided with written information to ensure voluntary participation, and written informed consent was obtained, with copies given to participants and originals retained at the study site.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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