Sound Healing for Anxiety: A Randomized Controlled Trial

Anxiety Clinical Trial

Official title:

Sound Healing for Anxiety: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100406
• Other study ID #: RCT001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Consciousness and Healing Initiative
• Contact: Lorna C Ciccone, ND
• Phone: 512-284-3655
• Email: lorna[@]chi.is
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety Generalized
• Anxiety State
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consciousness and Healing Initiative

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Microbiome changes	as measured by a microbiome sample	Baseline and 5 weeks
Primary	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	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
Secondary	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
Secondary	Interoceptive awareness	as measured by the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)	Baseline, at 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	relationship with practitioner	as measured by a Practitioner Relationship questionnaire	at 1 week, 3 weeks, and 5 weeks
Secondary	depressive symptoms	as measured by the PHQ-9	Baseline, at 3 weeks, 5 weeks and 1-month post-intervention