Sound Healing for Anxiety: A Randomized Controlled Trial

NCT ID: NCT06100406

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Anxiety; Mental Health Issue; Anxiety Generalized; Anxiety State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Biofield tuning

Intervention Type: 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.

Waitlist control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Biofield tuning

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.

Intervention Type: OTHER

Other Intervention Names

sound healing

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.).

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

Sponsors

Consciousness and Healing Initiative

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamini Jain, PhD

Role: PRINCIPAL_INVESTIGATOR

Consciousness and Healing Initiative

Hemal H Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Cassandra Vieten, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Central Contacts

Lorna C Ciccone, ND

Role: CONTACT

lorna@chi.is

512-284-3655

Chloe Tanega

Role: CONTACT

chloe@chi.is

References

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.

Reference Type: BACKGROUND

PMID: 26665043 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37023932 (View on PubMed)

Other Identifiers

RCT001

Identifier Type: -

Identifier Source: org_study_id