Sound Healing for Anxiety: A Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Anxiety State; Mental Health Issue; Anxiety Generalized
• Intervention / Treatment: Other: Biofield tuning

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorna C Ciccone, ND; Phone Number: 512-284-3655; Email: lorna@chi.is
• Study Contact Backup: Name: Chloe Tanega; Email: chloe@chi.is

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: sound healing
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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	Baseline and 5 weeks

Collaborators and Investigators

• Sponsor: Consciousness and Healing Initiative
• Investigators: Principal Investigator: Shamini Jain, PhD, Consciousness and Healing Initiative; Principal Investigator: Hemal H Patel, PhD, University of California, San Diego; Principal Investigator: Cassandra Vieten, PhD, University of California, San Diego

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RCT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: No individual data or identifiers will be shared with other researchers.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Subject code blinded. Treatment code blinded and unblinded for analyses.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No