Do you have Lower Back Pain?

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Purpose: You have been invited to take part in a research study on the healing effects of Sound Technology and how it may reduce the effects of chronic low back pain (CLBP) and insomnia and improve wellbeing. This study will allow the research investigators to quantify the benefits of this personalized approach. This project will be conducted by Hagen Rainbow, M.S., and Dr. Sanford Nidich, Ed.D., from the Dr. Tony Nader Institute, Maharishi International University (MIU) USA. The project will take place on www.healingsoundsresearch.com. Approximately 100 adults will be recruited to participate in the pilot randomized control study and screened for CLBP using Oswestry Disability Index (subjects with 15 points or more will be asked to participate in the study). Subjects will be randomized into two groups CLBP Treatment, and CLBP Control. Questionnaires to assess pain, well-being, depression, and stress will be given before and after the three sessions of Sound. Follow-up questionnaires will be done one month after treatment. The between-group differences will be measured using an analysis of variance (ANOVA). The evaluation will launch in October 2024. Sound Technology: Sounds are audio recordings that consist of one hour of relaxing sounds. Subjects will be randomly assigned to one of two groups, treatment or control. The specific sounds that are heard depend on which group is randomly assigned. The theory of how Sound can have a healing effect on the human body resides in the idea that all matter at a subtle level is vibration, and listening to certain sounds produces a powerful influence that reconnects the human physiology back to a healthy and orderly functioning state. Outline of Sound sessions: Each session is one hour and will be done twice a day for three days. At the beginning of the recording, 15 seconds of silence will give the subject time to put on the noise-canceling headphones and lie down comfortably in a quiet place, with eyes closed. The instructions are to “Listen easily and innocently to the sounds. It is the sound value and the value of the gaps between the sounds that are significant, not any meaning that you may attach to the sounds. If the mind wanders away from the sounds, easily bring your attention back to the sounds. If you feel tired, pause the streaming and rest until you feel ready to continue. Take care that you will not be disturbed, e.g. switch off your phone, close the door, etc. If you are disturbed, turn off the recitation and, if possible, take a minute or two before opening your eyes to deal with the interruption.” After the session is over, subjects are instructed to rest for ten minutes. Evaluation Procedure: You will be asked to complete multiple surveys before you receive the Sound sessions, after the sessions are complete, and one month after the sessions. With your consent, you will be asked to complete the following surveys that ask about: 1. Your perceptions and impact of stress and pain, in your own life. 2. Your experience of wellness in different areas of your life. In addition, you will be asked to complete a survey about your experiences during the Sound sessions and in daily activities. You may be asked to take part in semi-structured interviews for 30 minutes, conducted with select participants completing the final post-test. Risks: We will minimize the risk of confidential data being compromised by ensuring that only the researchers directly involved in the evaluation will have access to the evaluation’s data/files. The only risk that may be associated with participation in the survey instruments is that you may feel emotional discomfort when answering items about your emotional state. Benefits: Your participation in the evaluation of this project will enable us to gather further evidence of the effectiveness of Sound and help us secure further funding to expand the reach of this and other projects. It may also inspire others to seek out self-care programs for the purpose of reducing stress and improving their own quality of life. Compensation for Participation: There is no monetary compensation for participating in this study. However, you will benefit from receiving sessions to benefit your overall well-being. Confidentiality: This evaluation is for research purposes and all records relating to each subject will be kept confidential. Without your express permission, no information will be released or printed that would disclose your personal identity. Right to Withdraw: Your participation in this study is voluntary. You do not have to take part in this research study. You are free to withdraw your consent at any time. Refusal to take part or stop participating in the study will not involve any penalty or loss to you. If you decide to stop taking part or have questions, concerns, or complaints, please contact [email protected]. There are no adverse consequences (physical, social, economic, legal, or psychological) for deciding to withdraw from this research study. Can I be removed from the research?: The investigators can remove you from the research study without your approval. Possible reasons for removal include incomplete data, and non-compliance with completing tasks. In addition, the entire study can be stopped at any time by the University, investigators, Institutional Review Board (IRB), or the facility where the study is conducted. I certify that the research procedures described on this form have been explained to me and that any questions that I have asked have been answered to my satisfaction. I understand the benefits and possible risks (if any) of participating in this research. I know that I may ask now, or in the future, any questions I have about the evaluation or the research procedures. I have been assured that records relating to me will be kept confidential. I understand that I am free to withdraw from the evaluation at any time. I further understand that if I do not join the evaluation, or if I withdraw at any time, I will still be able to participate in the sessions and will not be penalized or lose benefits to which I am otherwise entitled. I may contact [email protected] to review the matter with me, and answer pertinent questions about the research and my rights. I consent to participate in this evaluation and complete the required surveys as outlined above. I commit to completing the Sound Sessions of one hour twice a day for 3 consecutive days. I am happy for content from the evaluation to be published in research studies and used in the public domain to promote Sound healing. Any content will remain anonymous and any names provided will not be used. I am 18 years of age or older (you must be 18 years or older to participate in this study). By clicking submit, I agree to the above terms.