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The goal of this randomized controlled trial is to compare a novel sound healing approach, biofield tuning, to a waitlist control group in a healthy adult population naive to the intervention. The main questions it aims to answer are:
Participants will be:
There is an increasing rate of anxiety among the US population, without adequate amounts of resources for treatment. Current pharmacological and psychological treatments for generalized anxiety disorder delivered by doctors, nurses, and clinical psychologists are often expensive and not freely available for many who need effective interventions for anxiety. A novel sound healing approach, Biofield Tuning (BT), has suggested potential benefits to those suffering from generalized anxiety. This intervention, while requiring training and certification, allows for holistic health practitioners to treat anxiety as a complementary mind-body therapy for those seeking relief for anxiety.
Intervention. BT is a non-invasive, non-medical therapeutic practice developed by Eileen Day McKusick. BT Practitioners use a tuning fork to identify off-the-body sites at which perturbations in the tuning fork sound are detected. Such sites are described by BT practitioners as storing health-related information within the human biofield. Practitioners describe the process of BT as assessing and clearing perturbations in the human biofield to foster healing.
Previous Feasibility Study. Our initial cohort study showed that conducting research for this novel sound healing approach online was feasible and suggested clinical benefits for people struggling with moderate to severe generalized anxiety, as noted in our peer-reviewed scientific publication. This RCT is designed to build upon the previous cohort study by comparing this intervention with a control group to further determine the effectiveness of BT compared to treatment as usual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Biofield Tuning is a non-invasive, non-medical therapeutic practice in which a resonating tuning fork is used to identify and re-balance off-the-body sites at which perturbations in the tuning fork sound are detected. The description of the intervention has been provided by Biofield Tuning Practitioners and thus describes the practitioner's experience and process while performing the intervention. For this study, the Biofield Tuning practitioner will be using a "hologram" of the participant's body since the intervention will be performed remotely. A "hologram" is when a BT practitioner imagines the body of the participant on the table in front of them. This approach was used successfully for our last feasibility study suggesting an impact of the virtually delivered BT intervention on anxiety. |
|
| Waitlist control | No Intervention | The waitlist control group will complete the same weekly self-report questionnaires outlined in the protocol as the intervention group and weekly audio recordings. Following their one-month follow-up questionnaire, those in the waitlist group will be offered a BT session at no cost. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofield tuning | Other | Biofield Tuning is a non-invasive, non-medical therapeutic practice in which a resonating tuning fork is used to identify and re-balance off-the-body sites at which perturbations in the tuning fork sound are detected. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | The main objective is to assess whether virtually-delivered biofield tuning can significantly reduce moderate to high levels of generalized anxiety as measured by the State Trait Anxiety Index (STAI). | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety 1-month | We also aim to understand how long BT intervention effects may last with a 1-month follow up as measured by the STAI. | 1-month post-intervention |
| Positive and Negative Affect | as measured by the Positive and Negative Affect Scale-Short Form (PANAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Spoken Language | As measured by a spoken prompt that will be recorded | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention |
| Microbiome changes | as measured by a microbiome sample |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorna C Ciccone, ND | Contact | 512-284-3655 | lorna@chi.is | |
| Chloe Tanega | Contact | chloe@chi.is |
| Name | Affiliation | Role |
|---|---|---|
| Shamini Jain, PhD | Consciousness and Healing Initiative | Principal Investigator |
| Hemal H Patel, PhD | University of California, San Diego | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26665043 | Background | Jain S, Hammerschlag R, Mills P, Cohen L, Krieger R, Vieten C, Lutgendorf S. Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations. Glob Adv Health Med. 2015 Nov;4(Suppl):58-66. doi: 10.7453/gahmj.2015.034.suppl. Epub 2015 Nov 1. | |
| 37023932 | Result | Jain S, McKusick E, Ciccone L, Sprengel M, Ritenbaugh C. Sound healing reduces generalized anxiety during the pandemic: A feasibility study. Complement Ther Med. 2023 Jun;74:102947. doi: 10.1016/j.ctim.2023.102947. Epub 2023 Apr 5. |
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No individual data or identifiers will be shared with other researchers.
2 years
Subject code blinded. Treatment code blinded and unblinded for analyses.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.
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Once randomized, the participants will know they are receiving the intervention. Outcomes assessor will be masked for data analysis.
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| Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention |
| Interoceptive awareness | as measured by the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) | Baseline, at 5 weeks |
| mental health recovery | as measured by the Recovery Assessment Scale- Revised (RAS-r). Scores range from 24 to 120. Items are rated from 1 to 5. Higher scores indicate higher levels of recovery. | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |
| stress | as measured by the Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |
| self compassion | as measured by the Self-Compassion Scale-Short Form (SCS-SF). The total score is an overall indication of self-compassion, with a higher score indicating more self-compassion. | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |
| perceived social support | as measured by the Multidimensional Scale of Perceived Social Support (MSPSS) | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |
| relationship with practitioner | as measured by a Practitioner Relationship questionnaire | at 1 week, 3 weeks, and 5 weeks |
| depressive symptoms | as measured by the PHQ-9 | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |
| Baseline and 5 weeks |
| Cassandra Vieten, PhD |
| University of California, San Diego |
| Principal Investigator |