Measuring the anxiety-reducing effects of Tibetan singing bowls

ISRCTN ISRCTN53976851
DOI https://doi.org/10.1186/ISRCTN53976851
Secondary identifying numbers Fondecyt 11190240
Submission date
01/02/2022
Registration date
07/02/2022
Last edited
07/02/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Anxiety is one of the major topics in mental health, representing a relevant societal problem. Although significant advances have been made, anxiety continues to be a major challenge and innovative approaches are still required. Preventive treatments are gaining significant relevance due to their effectiveness, suggesting that anxiety prevention programs should be further developed. The main aim of this study is to compare the magnitude of the relaxation response caused by a new sound-based treatment (Tibetan Singing Bowls [TBS]) against the well-validated Jacobson’s progressive muscle relaxation (PMR) and a control waiting list (CWL) group.

Who can participate?
People aged over 18 and under 60 years old with non-clinical anxiety

What does the study involve?
Participants will be randomly allocated to either Tibetan singing bowl treatment (TSB), progressive muscle relaxation (PMR) or a control waiting list (CWL).
Tibetan singing bowl treatment is provided live by an expert in a 30-min session. Four TSBs are used and participants are asked to sit in a comfortable armchair with their eyes closed while TSB sounds are smoothly provided. Heart rate and brain activity are continuously recorded.
In the PMR group instructions are provided using professional audio and speakers. A PMR 30-min session consists of tensing and relaxing groups of muscles in a bottom-up direction (feet, legs, chest, shoulders, arms, neck and face) following the instructions of the audio. Participants are asked to sit in a comfortable armchair with their eyes closed while following the instructions
Participants in the CWL group are asked to sit in a comfortable armchair with their eyes closed for 30 min. No treatment is delivered. After the session is over, participants in the CWL group choose between PMR or TSB treatment, which is provided on another day.

What are the possible benefits and risks of participating?
There is no risk in participating in this study. Participants will receive a treatment that should elicit a relaxation response, which might be of benefit to anyone.

Where is the study run from?
Austral University of Chile (Chile)

When is the study starting and how long is it expected to run for?
June 2019 to October 2024

Who is funding the study?
National Fund for Scientific and Technological Development (Chile)

Who is the main contact?
Dr Cristobal Río-Alamos
cristobal.delrio@uach.cl

Contact information

Dr Cristobal Río-Alamos
Principal Investigator

Department of psychology
Austral University of Chile
Campus Isla teja s/n
Valdivia
5090000
Chile

ORCiD logoORCID ID 0000-0002-5676-4494
Phone +56 (0)632 482184
Email cristobal.delrio@uach.cl

Study information

Study designSingle-blind prospective randomized control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet No participant information sheet available
Scientific titlePreventing effects of the relaxation response induced by a sound-based treatment in human anxiety: physiological, electroencephalographic and psychological outcomes
Study objectivesTibetan singing bowls (TSB) induce a more evident relaxation response in comparison with Jacobson's progressive muscle relaxation. Specifically, TSB should induce increases in heart rate variability, reductions in the alpha band (EEG) and reductions in self-report anxiety questionnaires in a more evident manner in comparison with Jacobson's progressive muscle relaxation.
Ethics approval(s)Approved 13/11/2019, Ethical Committee of Bioethics on Human Research of the Austral University of Chile (Campus Isla Teja s/n, Valdivia, Region de Los Ríos, Chile; +56 (0)632444314 Anexo (4314); comiteeticocientifico@uach.cl), ref: 0041/19
Health condition(s) or problem(s) studiedPrevention of anxiety
InterventionParticipants will be randomly assigned to either Tibetan singing bowl (TSB), progressive muscle relaxation (PMR) or control waiting list (CWL). The experimental session consists of a 30-min session in which heart rate variability (HRV) recorded with a Polar Q10 device, EEG recorded with the Emotiv device and pre/post self-report anxiety will be measured. Participants allocated to the CWL are able to choose PMR or TSB once their experimental session is over.

TSB methodology:
TSB is provided live by an expert in a 30-min session. Four TSB are used and participants are asked to sit in a comfortable armchair with their eyes closed while TSB sounds are smoothly provided. During the TSB session, EEG and HRV parameters are continuously recorded.

PMR methodology:
PMR instructions are provided using professional audio and Bose soundlink speakers. A PMR 30-min session consists of tensing and relaxing groups of muscles in a bottom-up direction (feet, legs, chest, shoulders, arms, neck and face) following the instructions of the audio. Participants are asked to sit in a comfortable armchair with their eyes closed while following the instructions

CWL:
Participants in the CWL group are asked to sit in a comfortable armchair with their eyes closed for 30 min. No treatment is delivered. After the session is over, participants in the CWL group choose between PMR or TSB treatment, which is provided on another day.
Intervention typeBehavioural
Primary outcome measureSelf-reported anxiety measured with the Spielberger State Anxiety Inventory (SAI) pre-experiment (SAI-1; 24 h before the experimental session) and post-experiment (SAI-2; immediately after the experimental session is over)
Secondary outcome measures1. Spectral power of theta, alpha and beta neuroelectric bands measured using Emotiv Epoc Flex gel-based sensors at T1 (baseline), T2 (10 min), T3 (20 min) and T4 (30 min)
2. Heart rate variability (HRV) recorded using a Polar Q10 device at T1 (baseline), T2 (10 min), T3 (20 min) and T4 (30 min)
3. EEG recorded with the Emotiv device at T1 (baseline), T2 (10 min), T3 (20 min) and T4 (30 min)
Overall study start date02/06/2019
Completion date30/10/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Over 18 and under 60 years old
2. No regular practice of relaxation techniques
3. Without any pharmacological treatment on course
4. Over 39-40 points on Spielberg´s state anxiety inventory as a measure of state anxiety
Key exclusion criteria1. Under 18 and over 60 years old
2. Previous experience with relaxing techniques (yoga, tai-chi, meditation, etc)
3. Being under current pharmacotherapy
Date of first enrolment30/06/2020
Date of final enrolment30/10/2024

Locations

Countries of recruitment

  • Chile

Study participating centre

Austral University of Chile
Department of Psychology
Campus isla teja s/n
Valdivia
5090000
Chile

Sponsor information

Austral University of Chile
University/education

Campus isla teja s/n
Valdivia
5090000
Chile

Phone +56 (0)63 2221257
Email viceacad@uach.cl
Website https://www.uach.cl/
ROR logo "ROR" https://ror.org/029ycp228

Funders

Funder type

Government

Fondo Nacional de Desarrollo Científico y Tecnológico
Government organisation / National government
Alternative name(s)
National Fund for Scientific and Technological Development, El Fondo Nacional de Desarrollo Científico y Tecnológico, FONDECYT
Location
Chile

Results and Publications

Intention to publish date15/06/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication

Editorial Notes

02/02/2022: Trial's existence confirmed by the Ethical Committee of Bioethics on Human Research of the Austral University of Chile.