Online Yoga Intervention as Tertiary Prevention of Psychological Comorbidities of Covid-19 Survivors
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1)Proposed OYI with and without herbal concoction is expected to improve the PTSD, Anxiety, Depression and Quality of Life of COVID-19 survivors in Experimental groups as compared to the controls.
研究概览
简要总结
Background
Covid-19 Survivors are often found with psychological comorbidities such as depression, anxiety, traumatic disorder (PTSD), and poor quality of life (QoL). Online integral yoga intervention including yoga poses, breath regulations, seals, meditation and concoction of the selected medicinal herbs as tertiary prevention of Covid-19 Survivors may be safe, cost effective, and harmless option to manage psychological comorbidities of Covid-19 survivors.
Objectives
To assess the effect of 1-month Online Yoga Intervention with and without herbal concoction on selected depression, anxiety, post traumatic disorder and quality of life of Covid-19 survivors.
Study Design
Three armed RCT with 22 clinically significant depressive/anxious Covid-19 survivors to each control, yoga and yoga cum concoction group. Covid-19 survivors aged from 15-60 years and SARS-Cov.2 infection induced clinically significant depression/anxiety and faith on yoga and ayurveda will be included. Those with severe prior health complications and infidelity to yoga and ayruveda will be excluded.
Measures
Beck Depression Inventory, Hamilton Anxiety Scale, Davidson Trauma Scale and WHO brief version of Quality Life Questionnaire will be used to measure baseline and after intervention depression, anxiety, PTSD and QOL of the participants.
Procedures and Protocol
After going through PIS and signing informed consent, the participants’ meeting IC will be shortlisted and randomized in three groups CG, YG and YCG for baseline data generation. Then, the participants of YG are expected to go through one-month online yoga classes (5 classes/week) by covering the yogic practices as mentioned in yoga protocol. The participants of YCG are expected to go through online yoga classes (5 classes/week)along with intake 150 ml of one-time concoction preferably in morning in empty stomach for one month. The intake of concoction will continue for one month without any break. Zoom App will be used as an interface for OYI. The procedure and precautions of concoction preparation will be detailed in online or offline meetings after baseline measurements. The said yoga protocol and concoction are harmless and claimed to moderate psychological comorbidities and recurrence of the infection in Covid-19 survivors. However, in case of special physical deformity/ disease, we would consult you in person and assist for needful care.
After completion of one month intervention, post data will be generated and the control group participants will be provided online video recordings related to online yoga intervention for their afterhand self-practice if desired.
Data Analysis
Repeated Measure ANOVAs with post hoc analyses will be performed by using 24th version of IBM SPSS.
Expected Outcomes
Proposed OYI with and without herbal concoction is expected to improve Covid-19 induced depression, anxiety, PTSD and poor QoL among Covid-19 survivors as safe, inexpensive, and harmless option.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •An email address, an internet-connected computer with camera and sound system/ tablet or 4G and/or Wi-Fi enabled Smartphone (running Google chrome).
- •Symptomatic medical history of at least 2 month back and BDI Score≥10 or Hamilton Anxiety Scale Score greater than or equal to 17.
排除标准
- •Participants with medical health issues as under before the onset of clinical symptoms of Covid-19 infection: Neurological, hypertension, diabetes mellitus, Cardiovascular disease, renal complications, liver disorders, locomotors disabilities, glaucoma, hernia, ulcers of the stomach or intestine, recent abdominal or spinal surgery, pregnancy/lactating phase, addictive behaviors (smoking, alcoholism, tobacco chewing) and age below 15 and above 60 years.
结局指标
主要结局
1)Proposed OYI with and without herbal concoction is expected to improve the PTSD, Anxiety, Depression and Quality of Life of COVID-19 survivors in Experimental groups as compared to the controls.
时间窗: Staff Recruitment & training: 01-15 July 2021 | Recruitment of Participants, Randomization: 15 July- 15 August 2021 | Baseline scoring of instruments: 15-30 August 2021 (4 weeks) | Final scoring of instruments after intervention: 01-05 September 2021 (one week) | Data Entry and Analysis: 15-30 September 2021 | Compilation of annual report: October-November 2021
2)If this OYI protocol proves to be effective, then it may be a good option for over millions global COVID-19 survivors to overcome comorbidities, boost immunity and restore health.
时间窗: Staff Recruitment & training: 01-15 July 2021 | Recruitment of Participants, Randomization: 15 July- 15 August 2021 | Baseline scoring of instruments: 15-30 August 2021 (4 weeks) | Final scoring of instruments after intervention: 01-05 September 2021 (one week) | Data Entry and Analysis: 15-30 September 2021 | Compilation of annual report: October-November 2021
次要结局
- Anxiety, Post Traumatic Stress Disorder and Quality of Life