TinnitusNCT04988399
Internet-based Reiki for Tinnitus 2021
A study testing Reiki in people with Tinnitus, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The objectives of the study will be 1) to develop and show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus, 2) to deliver Reiki therapy for tinnitus as a potential treatment, 3) to maintain a meaningful cohort of participants over a 6-month protocol, and 4) to collect pilot data on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Jul 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English or Spanish speaking patients with unilateral or bilateral tinnitus
Who cannot join
- People under the age of 18
- People without internet access
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Feasibility of Internet-based Reiki as an Intervention for Tinnitus
The objectives of the study will be 1) to develop and show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus, 2) to deliver Reiki therapy for tinnitus as a potential treatment, 3) to maintain a meaningful cohort of participants over a 6-month protocol, and 4) to collect pilot data on the potential benefit of internet-based Reiki therapy on tinnitus-related quality of life. Patients will also be provided with information on other potential tinnitus therapies.
Read the detailed description
Reiki is a wellness practice of energy healing that began in Japan and is now practiced throughout the world. The principle of Reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease. Reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems. Reiki is considered by practitioners to be a great tool for stress reduction and relaxation (International Association of Reiki Practitioners).
Many people use Reiki for wellness. Reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. According to the Center for Reiki Research, Reiki is an effective approach for reducing pain, depression, and anxiety. Tinnitus is a pain percept, and it is likely Reiki may reduce pain and anxiety in patients with tinnitus.
The aims of the study are to show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus. Home based therapy can reduce the stress of receiving therapy in an unfamiliar environment. Home-based therapy can also allow the participants to regain more control their surroundings, making them more likely to benefit from relaxation and stress relief benefits of Reiki.
Specific Aim 1: The first aim is to show that our Reiki therapy can be delivered to tinnitus patients on an internet-based platform This aim will be achieved if the investigators can recruit patients into the study and deliver internet-based therapy over the 6 months of the protocol while retaining a meaningful 30 percent of our cohort.
Specific Aim 2: The second aim is to show that participants perceive a benefit from the therapy protocol. This aim will be studied by retaining a meaningful cohort of participants and by analyzing data from the questionnaire results for the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI) before treatment, at 3 months and after 6 months of treatment and comparing them to the participants' baseline questionnaires. Data from the questionnaires will be used to determine sample size needed for a larger blinded control study.
- Conditions
- Tinnitus
- Being tested
- Reiki
- Keywords
- Tinnitus, Reiki
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
Reiki is a wellness practice of energy healing that began in Japan and is now practiced throughout the world. The principle of Reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease (Doğan 2018). Reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems (McManus, 2017, p. 1056). Reiki is considered by practitioners to be a great tool for stress reduction and relaxation (International Association of Reiki Practitioners). Many people use Reiki for wellness. Reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. According to the Center for Reiki Research, Reiki is an effective approach for reducing pain, depression, and anxiety. Tinnitus is a pain percept, and it is likely Reiki may reduce pain and anxiety in patients with tinnitus.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Recipients | Experimental | The Practitioner enters a gassho (two hands coming together at the heart) meditative state with the Distance Symbol. Reiji-ho - moving the joined hands until the thumbs touch the space between the brows. Going into a relaxed state by using a breathing technique. Say the person's name three times. Proceed with byosen (method using the sensitivity in the hands to treat those areas in need of Reiki) scanning technique. Chiryo (standard session visualizing all hand positions) for 5 minutes each: Jawbone-Back of the head-Throat-Lungs-Area of participant's concern-Stomach-Intestines-Kidneys-Spinal cord. At the end of the session, visualize towards the participant's feet to help integrate the healing. Visualize brushing the Biomagnetic field around the participant's body from head to feet. Inform the participant that the session has been completed. Include time to rest quietly for a few minutes. Encourage participant to sip water (if they prefer) and ask them about their experience. Receives: Other: Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported Tinnitus Relief
Change from baseline after Reiki treatment for tinnitus sufferers. Reduced stress in tinnitus sufferers seen as changes of the Tinnitus Handicap Inventory or Tinnitus Functional Index. Maximum possible score = 250 if the respondent were to rate all 25 TFI items at the maximum value of 10.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jun 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Why it stopped: Withdrawn prior to Einstein IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Dinces, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988399
- Sponsor's protocol ID
- 2021-12737
- Status last verified
- May 2023
- First submitted
- 16 Jul 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Internet-based Reiki as an Intervention for Tinnitus
- ClinicalTrials.gov ID
- NCT04988399
- Acronym / sponsor ID
- 2021-12737
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Reiki
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn prior to Einstein IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 3 Aug 2021 (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.
The objectives of the study will be 1) to develop and show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus, 2) to deliver Reiki therapy for tinnitus as a potential treatment, 3) to maintain a meaningful cohort of participants over a 6-month protocol, and 4) to collect pilot data on the potential benefit of internet-based Reiki therapy on tinnitus-related quality of life. Patients will also be provided with information on other potential tinnitus therapies.
Detailed description
Reiki is a wellness practice of energy healing that began in Japan and is now practiced throughout the world. The principle of Reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease. Reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems. Reiki is considered by practitioners to be a great tool for stress reduction and relaxation (International Association of Reiki Practitioners).
Many people use Reiki for wellness. Reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. According to the Center for Reiki Research, Reiki is an effective approach for reducing pain, depression, and anxiety. Tinnitus is a pain percept, and it is likely Reiki may reduce pain and anxiety in patients with tinnitus.
The aims of the study are to show the feasibility of an internet-based Reiki therapy as an intervention for tinnitus. Home based therapy can reduce the stress of receiving therapy in an unfamiliar environment. Home-based therapy can also allow the participants to regain more control their surroundings, making them more likely to benefit from relaxation and stress relief benefits of Reiki.
Specific Aim 1: The first aim is to show that our Reiki therapy can be delivered to tinnitus patients on an internet-based platform This aim will be achieved if the investigators can recruit patients into the study and deliver internet-based therapy over the 6 months of the protocol while retaining a meaningful 30 percent of our cohort.
Specific Aim 2: The second aim is to show that participants perceive a benefit from the therapy protocol. This aim will be studied by retaining a meaningful cohort of participants and by analyzing data from the questionnaire results for the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI) before treatment, at 3 months and after 6 months of treatment and comparing them to the participants' baseline questionnaires. Data from the questionnaires will be used to determine sample size needed for a larger blinded control study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reiki Recipients | Experimental | Other: ReikiThe Practitioner enters a gassho (two hands coming together at the heart) meditative state with the Distance Symbol. Reiji-ho - moving the joined hands until the thumbs touch the space between the brows. Going into a relaxed state by using a breathing technique. Say the person's name three times. Proceed with byosen (method using the sensitivity in the hands to treat those areas in need of Reiki) scanning technique. Chiryo (standard session visualizing all hand positions) for 5 minutes each: Jawbone-Back of the head-Throat-Lungs-Area of participant's concern-Stomach-Intestines-Kidneys-Spinal cord. At the end of the session, visualize towards the participant's feet to help integrate the healing. Visualize brushing the Biomagnetic field around the participant's body from head to feet. Inform the participant that the session has been completed. Include time to rest quietly for a few minutes. Encourage participant to sip water (if they prefer) and ask them about their experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English or Spanish speaking patients with unilateral or bilateral tinnitus
Key exclusion criteria (2 listed)
- People under the age of 18
- People without internet access
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 |
|---|---|---|
| ReikiReiki is a wellness practice of energy healing that began in Japan and is now practiced throughout the world. The principle of Reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease (Doğan 2018). Reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems (McManus, 2017, p. 1056). Reiki is considered by practitioners to be a great tool for stress reduction and relaxation (International Association of Reiki Practitioners). Many people use Reiki for wellness. Reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. According to the Center for Reiki Research, Reiki is an effective approach for reducing pain, depression, and anxiety. Tinnitus is a pain percept, and it is likely Reiki may reduce pain and anxiety in patients with tinnitus. | Other | Reiki Recipients |
Primary outcome
Reported Tinnitus Relief
Time frame: 6 months
Change from baseline after Reiki treatment for tinnitus sufferers. Reduced stress in tinnitus sufferers seen as changes of the Tinnitus Handicap Inventory or Tinnitus Functional Index. Maximum possible score = 250 if the respondent were to rate all 25 TFI items at the maximum value of 10.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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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.
Elizabeth Dinces, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki in people with Tinnitus, run by Montefiore Medical Center at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 31 May 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reported Tinnitus Relief (time frame: 6 months). 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 31 May 2023.