An Investigator-Initiated Prospective, Open Labelled Comparative Study to Evaluate the Clinical Outcomes Like Performance, Effectiveness, and Safety of a Non-Invasive Smart Patch InnerGize and Sham device to Reduce Stress and Anxiousness and promote relaxation in Healthy Volunteers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To evaluate the performance outcomes like variations in stress, anxiousness and relaxation, experienced by Healthy Volunteers with the Non-Invasive Smart Patch InnerGize arm and a sham device arm throughout the study period.
Study Overview
Brief Summary
The primary objective of this study is to assess how the Non-Invasive Smart Patch InnerGize impacts various physiological and psychological outcomes, particularly focusing on changes in stress, anxiety, and relaxation levels among healthy volunteers. Participants will use the InnerGize patch, and their experiences will be compared to those using a sham device (a placebo device with no therapeutic effects) over the course of the study. By monitoring these variables, the study aims to determine the effectiveness of the Non-Invasive Smart Patch in reducing stress and anxiety while promoting relaxation.
In addition to evaluating these performance outcomes, the study also seeks to examine the overall efficacy of the Non-Invasive Smart Patch InnerGize in comparison to the sham device, providing insight into how well the device works in real-world conditions. The study will also investigate the safety of the patch, ensuring that it does not cause any adverse effects or harm to the participants during the study period. Ultimately, the goal is to provide a comprehensive evaluation of both the benefits and risks associated with the use of the Non-Invasive Smart Patch InnerGize in comparison to a non-functional sham device.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or Female patients in the age group from 18 to 60 years.
- •Healthy volunteers stressed out due to the daily routine, work related for at least 2 weeks without receiving any alternative treatment in the past 3 months will be deemed suitable as per eligibility and will be approached regarding enrolment in the study.
- •Patients who are willing to provide a written informed consent form before initiation of the study.
- •Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion Criteria
- •Pregnant or lactating mother.
- •Patients with metallic and active implants in their body, such as pacemakers or hearing aids, should refrain from using the product
- •Patients with uncontrolled hypertension, cardiovascular diseases, or a history of Seizures
- •Significant systemic illness or occult systemic illness, or any other care or medication which may interfere with the InnerGize care
- •Not willing to obtain a written informed consent form to participate in the study.
- •Patients involved in clinical trials and taken similar investigational products within 3 months before initiation of the study.
- •Any severe, acute, or chronic medical condition that may affect the patients ability to participate in the study, may lead to unacceptable security risks and non-compliance with protocol procedures or may interfere with the interpretation of the study results.
Outcomes
Primary Outcomes
To evaluate the performance outcomes like variations in stress, anxiousness and relaxation, experienced by Healthy Volunteers with the Non-Invasive Smart Patch InnerGize arm and a sham device arm throughout the study period.
Time Frame: Day 1 - (Visit-I) Screening + Treatment - Pre stimulation + Post stimulation | Day 2 - (Visit II) - Telephonic Follow up | Day 3 - (Visit III) - Telephonic Follow up | Day 4 - (Visit IV) - Telephonic Follow up
Secondary Outcomes
- Change in Customized questionnaire before the session ("pre-stimulation") & after the session ("post-stimulation") with Non-Invasive Smart Patch InnerGize & Sham device.(Day 1 - (Visit-I) Screening & treatment)
Investigators
Dr Aradhana Kaul Kathju
Vasundhara Hospital Limited