PainNCT05795322
Acute Effect of Sound Healing on Pain, Fatigue and Mood
An observational study of Pain and Fatigue, run by Innowage Limited at 1 site in United Kingdom.
Trial summary
There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Fatigue, Mood Change
- What is being tested?
- Sound healing with tuning forks
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2023to 5 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People aged between 18-85, having long term illnesses for more than 6-month, completed 30-mins selected sound healing track with tuning forks virtually and shared their impact post session, were evaluated retrospectively.
Who may be able to join
- People with long term illnesses who attended 'Tuning for Health' virtual session
Who cannot join
- Who did not complete 30-mins Sound Healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Sound Healing on Pain, Fatigue and Mood: A Retrospective Community Based Study
There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. This study examined responses to a single session of sound healing and explored whether responses varied based on analogue pain, fatigue, and mood.
- Conditions
- Pain, Fatigue, Mood Change
- Being tested
- Sound healing with tuning forks
- Keywords
- Sound healing with tuning forks
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound healing with tuning forksOther
Over the course of a half-hour virtual session, a specially developed "triple OM track" created by tuning forks was played.
| Study group | Role | What they receive |
|---|---|---|
| Tuning for Health | Community based group 'Tuning for Health' was set up to provide chronic condition self-management support to people. Trained, experienced therapist-led group used half an hour of sound healing in virtual session. Receives: Other: Sound healing with tuning forks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Visual Analogical Scale (VAS) from 0 to 10 scores where 0 describes no pain and 10 worst pain.
Measured: From baseline to 30-minutes post intervention
Change in Fatigue
Visual Analogue Scale for Fatigue (VAS-F) with18 items relating to the subjective experience of fatigue, with each item representing how they currently feel along a visual analogue scale extending between two extremes (e.g., "not at all tired" to "extremely tired").
Measured: From baseline to 30-minutes post intervention
Change in Mood
Visual Analogue Mood Scale using vertical 100 mm lines and schematic faces representing the following mood states: sad, afraid, angry, tired, energetic, happy, and confused.
Measured: From baseline to 30-minutes post intervention
Secondary outcomes (1)
Patients Satisfaction
Patients Satisfaction was measured using 5-Linkert Scale (Very dissatisfied, Somewhat dissatisfied, Neutral, Somewhat satisfied, Very satisfied)
Measured: From baseline to 30-minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start24 Feb 2023
- Primary completion4 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innowage Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aarogyam UK, Suara Sound Academy
- Responsible party
- Sponsor
- Investigators
- Debbi Walker, Study director, Suara Sound AcademyNeha Sharma, PhD, Principal investigator, Aarogyam UK CIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795322
- Sponsor's protocol ID
- Inn-AA-SS-002
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Sound Healing on Pain, Fatigue and Mood: A Retrospective Community Based Study
- ClinicalTrials.gov ID
- NCT05795322
- Acronym / sponsor ID
- Inn-AA-SS-002
- Conditions
- Pain, Fatigue, Mood Change
- Keywords
- Sound healing with tuning forks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Innowage LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Aarogyam UK, Suara Sound Academy
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. This study examined responses to a single session of sound healing and explored whether responses varied based on analogue pain, fatigue, and mood.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tuning for Health | – | Other: Sound healing with tuning forksCommunity based group 'Tuning for Health' was set up to provide chronic condition self-management support to people. Trained, experienced therapist-led group used half an hour of sound healing in virtual session. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People aged between 18-85, having long term illnesses for more than 6-month, completed 30-mins selected sound healing track with tuning forks virtually and shared their impact post session, were evaluated retrospectively.
Key inclusion criteria (1 listed)
- People with long term illnesses who attended 'Tuning for Health' virtual session
Key exclusion criteria (1 listed)
- Who did not complete 30-mins Sound Healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound healing with tuning forksOver the course of a half-hour virtual session, a specially developed "triple OM track" created by tuning forks was played. | Other | Tuning for Health |
Primary outcome
Change in Pain Intensity
Time frame: From baseline to 30-minutes post intervention
Visual Analogical Scale (VAS) from 0 to 10 scores where 0 describes no pain and 10 worst pain.
Change in Fatigue
Time frame: From baseline to 30-minutes post intervention
Visual Analogue Scale for Fatigue (VAS-F) with18 items relating to the subjective experience of fatigue, with each item representing how they currently feel along a visual analogue scale extending between two extremes (e.g., "not at all tired" to "extremely tired").
Change in Mood
Time frame: From baseline to 30-minutes post intervention
Visual Analogue Mood Scale using vertical 100 mm lines and schematic faces representing the following mood states: sad, afraid, angry, tired, energetic, happy, and confused.
1 secondary outcome
Patients Satisfaction
Time frame: From baseline to 30-minutes post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbi Walker study director
Suara Sound Academy
Neha Sharma, PhD principal investigator
Aarogyam UK CIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Fatigue, run by Innowage Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: From baseline to 30-minutes post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.