Internet-based Reiki for Tinnitus 2021

NCT ID: NCT04988399

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-07-31

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.

Conditions

Tinnitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reiki Recipients

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.

Group Type: EXPERIMENTAL

Reiki

Intervention Type: OTHER

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.

Interventions

Reiki

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Dinces, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

2021-12737

Identifier Type: -

Identifier Source: org_study_id