AnxietyNCT06100406
Sound Healing for Anxiety: A Randomized Controlled Trial
A study testing Biofield tuning in people with Anxiety and Mental Health Issue, run by Consciousness and Healing Initiative.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Mental Health Issue, Anxiety Generalized
- What is being tested?
- Biofield tuning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years or older (≥ 18)
- Biofield-tuning naive (have never had a session of biofield tuning before)
- Speak and understand English at a native level
- Have a score ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- Have regular access to a computer
- Have experience using a computer
- Be comfortable using Zoom and completing data collection activities online and over the phone
Who cannot join
- Suffering from any severe psychological, physical, or cognitive disease or impairment.
- An active diagnosis or history of suicidality, Post-Traumatic Stress Disorder (PTSD), schizophrenia, or psychotic disorders. This includes history or current suicidality, suicide ideation, and intent to harm self or others.
- Women who are pregnant or nursing.
- Having an electronically implanted device, excluding cochlear implants.
- Currently seeking treatment for an active cancer.
- Currently has an untreated serious illness (e.g. heart disease, diabetes, etc.).
Trial locations and contacts
No sites are listed yet.
Chloe Tanega contact
About this study
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:
- Is there a significant reduction in state and trait anxiety as measured by the State-Trait Anxiety Index (STAI) with biofield tuning compared to waitlist control?
- Are there significant reductions in negative affect, as well as increases in self-compassion, positive affect, and interoceptive awareness in the intervention group?
- What are the relationships between changes in anxiety symptoms, negative affect words, and microbiome changes in participants who have undergone this biofield intervention?
Read more
Participants will be:
- Randomized to intervention/control
- Recieve 5 sound healing interventions weekly
- Asked to complete surveys and audio prompts throughout the intervention
- Asked to provide a microbiome sample pre- and post-intervention
Read the detailed description
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.
- Conditions
- Anxiety, Mental Health Issue, Anxiety Generalized, Anxiety State
- Being tested
- Biofield tuning
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofield tuningOther
Also called sound healing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biofield tuning |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks
Secondary outcomes (9)
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.
Measured: 1-month post-intervention
Positive and Negative Affect
as measured by the Positive and Negative Affect Scale-Short Form (PANAS)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
relationship with practitioner
as measured by a Practitioner Relationship questionnaire
Measured: at 1 week, 3 weeks, and 5 weeks
depressive symptoms
as measured by the PHQ-9
Measured: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consciousness and Healing Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamini Jain, PhD, Principal investigator, Consciousness and Healing InitiativeHemal H Patel, PhD, Principal investigator, University of California, San DiegoCassandra Vieten, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100406
- Sponsor's protocol ID
- RCT001
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No individual data or identifiers will be shared with other researchers.
Publications
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.
PubMed 26665043Jain 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.
PubMed 37023932
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound Healing for Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06100406
- Acronym / sponsor ID
- RCT001
- Conditions
- Anxiety, Mental Health Issue, Anxiety Generalized, Anxiety State
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Consciousness and Healing InitiativeUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a significant reduction in state and trait anxiety as measured by the State-Trait Anxiety Index (STAI) with biofield tuning compared to waitlist control?
- Are there significant reductions in negative affect, as well as increases in self-compassion, positive affect, and interoceptive awareness in the intervention group?
- What are the relationships between changes in anxiety symptoms, negative affect words, and microbiome changes in participants who have undergone this biofield intervention?
Participants will be:
- Randomized to intervention/control
- Recieve 5 sound healing interventions weekly
- Asked to complete surveys and audio prompts throughout the intervention
- Asked to provide a microbiome sample pre- and post-intervention
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Biofield tuningBiofield 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be 18 years or older (≥ 18)
- Biofield-tuning naive (have never had a session of biofield tuning before)
- Speak and understand English at a native level
- Have a score ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- Have regular access to a computer
Key exclusion criteria (6 listed)
- Suffering from any severe psychological, physical, or cognitive disease or impairment.
- An active diagnosis or history of suicidality, Post-Traumatic Stress Disorder (PTSD), schizophrenia, or psychotic disorders. This includes history or current suicidality, suicide ideation, and intent to harm self or others.
- Women who are pregnant or nursing.
- Having an electronically implanted device, excluding cochlear implants.
- Currently seeking treatment for an active cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofield tuningAlso: sound healingBiofield 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. | Other | Intervention |
Primary outcome
Anxiety
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks
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).
9 secondary outcomes
Anxiety 1-month
Time frame: 1-month post-intervention
Positive and Negative Affect
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention
Interoceptive awareness
Time frame: Baseline, at 5 weeks
mental health recovery
Time frame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
stress
Time frame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
self compassion
Time frame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
perceived social support
Time frame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
relationship with practitioner
Time frame: at 1 week, 3 weeks, and 5 weeks
depressive symptoms
Time frame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Background: PubMed 26665043Jain 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.
- Results publication: PubMed 37023932Jain 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.
- Individual participant dataSharing planned: Yes. No individual data or identifiers will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloe Tanega contact
Shamini Jain, PhD principal investigator
Consciousness and Healing Initiative
Hemal H Patel, PhD principal investigator
University of California, San Diego
Cassandra Vieten, PhD principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A study testing Biofield tuning in people with Anxiety and Mental Health Issue, run by Consciousness and Healing Initiative.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorna C Ciccone, ND (512-284-3655, lorna@chi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.