NCT04988399

Brief 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 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

July 16, 2021

Last Update Submit

May 29, 2023

Conditions

Keywords

TinnitusReiki

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

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.

Other: Reiki

Interventions

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.

Reiki Recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English or Spanish speaking patients with unilateral or bilateral tinnitus

You may not qualify if:

  • People under the age of 18
  • People without internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Elizabeth Dinces, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 3, 2021

Study Start

June 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations