Clinical trial NCT04988399: Internet-based Reiki for Tinnitus 2021
Official title: Feasibility of Internet-based Reiki as an Intervention for Tinnitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Reiki
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking patients with unilateral or bilateral tinnitus

Exclusion Criteria:

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

Primary outcomes:
measure: Reported Tinnitus Relief
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Elizabeth Dinces, MD
role: PRINCIPAL_INVESTIGATOR
References: