Sound Healing for Anxiety: A Randomized Controlled Trial

NCT06100406 | Unknown

• 1 other identifier: RCT001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anxiety; Mental Health Issue; Anxiety Generalized; Anxiety State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Anxiety 1-month

  1-month post-intervention

• Positive and Negative Affect

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention

• Interoceptive awareness

  Baseline, at 5 weeks

• mental health recovery

  Baseline, at 3 weeks, 5 weeks and 1-month post-intervention

• stress

  Baseline, at 3 weeks, 5 weeks and 1-month post-intervention

Other Outcomes (2)

• Spoken Language

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention

• Microbiome changes

  Baseline and 5 weeks

Study Arms (2)

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.

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.

Interventions

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.

Also known as: sound healing

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Consciousness and Healing Initiative: lead

Related 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.

  PMID: 26665043 BACKGROUND

• 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.

  PMID: 37023932 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorna C Ciccone, ND

CONTACT

512-284-3655; lorna@chi.is

Chloe Tanega

CONTACT

chloe@chi.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Once randomized, the participants will know they are receiving the intervention. Outcomes assessor will be masked for data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 25, 2023
• Study Start: January 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: Subject code blinded. Treatment code blinded and unblinded for analyses.