This prospective open-label randomized controlled study was carried out at the super-specialty referral center (Level III covid care center) from Sept 2020 through Feb 2021. The study was approved by Institutional Ethics Committee [IEC code: 2020-165-IP-EXP-22]. The trial was registered at the Clinical Trials Registry of India [REF/CTRI/2020/07/026609]. Frontline COVID health care workers (HCW) on COVID-19 duty (Physicians, Residents, and Staff Nurses) during the study period, agreeing to participate were included in the study.
Inclusion and Exclusion criteria
Frontline HCWs with the knowledge of the English language, who were involved in the active care of COVID-19 patients and willing to participate in the study were included in the study. HCWs who became symptomatic of COVID-19 during the study period needing hospitalization and HCWs not practicing interventions after randomization were excluded from the study.
Sample size calculation
Sample size was calculated taking into consideration that, Supine Relaxation Technique (SRT) and Yoganidra would reduce the Depression, Anxiety, and Insomnia in frontline HCWs with an assumed reduction in SRT and Yoganidra of 25% and 60% respectively. At minimum two-sided 95% confidence interval and 80% power of the study, the estimated sample size in each of the two groups was 27. After adjusting 20% loss to follow up, finally, we targeted randomizing 33 HCWs in each of the two groups. However, patients were continuously recruited further even after completion of sample size, and the same randomization table was repeated. The sample size was estimated using free software G*Power 3.1.9.2.
Recruitment and randomization
By taking into consideration of Covid duty roster of frontline HCWs, they were contacted telephonically and briefed in detail about the study including objectives and methodology one day before their scheduled duty for the COVID-19 health center. Randomization was performed using a computer-generated list of random numbers and allocation was followed in sequentially numbered sealed envelopes. The block randomization method was used to draw the random number between 1 to 66 with 33 in each group where seed number (101357327907440) with block size 6 were used. The envelopes were opened by a person who was not involved in the study and participants were allotted to particular groups in sequence. Health care workers were randomly allocated into the SRT group or Yoga Nidra.
Intervention
Since HCWs were dealing with a highly contagious virus, and strict isolations and social distancing were mandatory to curb the disease spread, it was not possible to deliver the content in physical mode and common sessions were not possible, the instructions for relevant sessions were practiced virtually using digital YouTube platform. Hence, all the participant HCWs were contacted telephonically, familiar social messaging applications were used and relevant participatory digital materials were given. All willing participants were given the electronic questionnaire consisting of demographics; Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7) scale, and 7-item Insomnia Severity Index (ISI) scale, and responses were collected in online forms. After randomization to particular groups, relevant YouTube links (particular to the study arms) were delivered using a smartphone device. Participant HCWs were reminded twice daily for the entire duration of the study period for particular techniques and were asked to practice the relevant method at their convenience due to altered circadian and rapid shift changes nature of duties.
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Group A / SRT (Supine Relaxation Technique) Group: In the Supine Relaxation Technique (a form of Mindfulness meditation), HCWs were asked to lie down in a supine position comfortably on the floor and were asked to listen to deep sleep music with eyes closed and relaxed for 30 min duration. A YouTube link containing the details about the ‘Deep Sleep Music’ (https://www.youtube.com/watch?v=FaRrq7cYu84) was sent to the participants [26].
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Group B / Yoganidra Group: Yoganidra (which is a state of dynamic yogic sleep) is a state of consciousness between waking and sleeping. In this group, HCWs were asked to lie down in a supine position comfortably and were asked to listen to Yoga Nidra instructions with eyes closed and relaxed for 30 min duration. Video demonstration of Yoga Nidra (https://www.youtube.com/watch?v=R2GRhAFplkI) (by Swami Niranjanananda Saraswati – Beginners) of 30 minutes duration was used for practicing Yoga Nidra [27]. All participant HCWs were followed on daily basis for 15 days i.e., the duration of covid duty period.
Completion of intervention
Intervention was considered as complete when the participants completed at least 9 days of practice. Frontline HCWs not practicing interventions for a minimum of 9 days were excluded from the final analysis.
Primary outcome
Changes in scores of PHQ-9 scale, GAD-7 scale, and ISI scale measurements before and after completion of COVID duty.
Secondary outcomes were rate of recruitment and completion of study interventions; and satisfaction concerning accessibility of content through YouTube digital platform, the digital content, and interventions relevancy and recommendations to the peer group.
Data collection
Changes in depression, anxiety, and insomnia scores were measured using the PHQ-9 scale [28], GAD-7 scale [29] and ISI score scales [30] respectively. These validated scales were copyright-free and were free to use and were available for download from the internet with instructions on measurement. PHQ-9 scale (range 0–27) was interpreted as Normal/minimal (0–4), Mild (5–9), Moderate (10–14), Moderately severe (15–19), and Severe (20–27) depression. GAD-7 (range 0–21) was interpreted as Normal/minimal (0–4), Mild (5–9), Moderate (10–14), Severe (15–21) anxiety. ISI scale (range 0–28) was interpreted as no clinically significant insomnia (0–7), Subthreshold insomnia (8–14), Moderate severity clinical insomnia (15–21), and Severe clinical insomnia (22–28). The Cut off scores for detecting symptoms of major depression, anxiety, insomnia were 10, 7, and 15 respectively. All data were self-reported by participants. Rate of recruitment, rate of completion of the intervention, and rate of satisfaction were noted. Satisfaction was measured using the accessibility of content through YouTube digital platform, the digital content, and relevancy using dichotomized questionnaires (Yes/ No).
Statistical analysis
Data were collected using Google forms and transferred into Microsoft Excel 2010. Continuous variables were presented in mean ± standard deviation/median (Interquartile range or IQR). Between SRT and Yoga groups, means were compared using independent samples t-test whereas data presented in medians were compared by Mann Whitney U test. To test the change in pre and post observation between continuous measurements, Wilcoxon signed rank test was used. Categorical variables were presented in frequency (%) and compared by chi-squared test / Fischer’s exact test. Cohen Effect size was calculated between the paired differences of the means detected for SRT and Yoga Nidra patients. P-value < 0.05 was taken as statistically significant. Statistical package for social sciences version-23 (SPSS-23, IBM, Chicago, USA) used for data analysis.