Mathad 2017.
| Study characteristics | ||
| Methods | Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): A priori computation of sample size using G* Power version 3.1.9.2, revealed 64 participants were required with an effect size 0.347 at an α value of 0.05 and with an actual power of 0.80 Imputation of missing data: no imputation of missing data; per‐protocol analysis (only participants who did not drop out from IG or CG; i.e. 80 participants analysed according to authors) | |
| Participants |
Country: India
Setting: nursing students; training setting not specified
Age: mean = 19.5 (SD = 1.28) years
Sample size (randomised): 100
Sex: all women
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: nursing students (1st and 2nd year General Nursing and Midwifery (GNM) and 1st to 3rd year Bachelor of Scence Nusing (BSc Nursing)) Inclusion criteria: 1) female students aged between 17 and 30 years; 2) willing to learn yoga Exclusion criteria: 1) students diagnosed with severe neurological or psychiatric illness; 2) students receiving treatment for hormonal imbalance; 3) who recently underwent surgical intervention; 4) students regularly practising yoga Attrition (withdrawals and exclusions): 20 dropouts (IG: 10, CG: 10) Reasons for missing data: for 20 dropouts: 5: sick (IG: 3, CG: 2); 2: could not attend due to personal reasons (IG); 7: were not willing (to attend) (IG: 3, CG: 4); 3: excluded during data analysis (IG: 2, CG: 1); 1 started treatment for hypothyroidism (CG); 2: discontinued the course (CG) |
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| Interventions |
Intervention: yoga intervention (n = 50)
Control: wait‐list control (n = 50)
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| Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) post‐intervention Adverse events: not specified |
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| Notes |
Contact with authors: We contacted the authors for the number of participants aged ≥ 18 years in the final sample and if they could provide the subgroup data for these participants (Mathad 2019 [pers comm]) Study start/end date: May 2015 – July 2015 Funding source: not specified Declaration of interest: no financial or other competing interests Ethical approval needed/obtained for study: approval of Institutional Ethics Committee was obtained for this study {RES/IEC‐SVYASA/59/2015} Comments by study authors: not relevant Miscellaneous outcomes by the review authors: information received from authors: "Data was analysed for 80 participants who were 18 years and above", i.e. no participants < 18 years in final (analysed) sample Correspondence: Ms Monali Devaraj Mathad; Research Scholar, Department of Division of Yoga and Humanities, S‐VYASA University, #19, Eknath Bhavan, Gavipuram Circle, Kempe Gowda Nagar, Bengaluru‐560019, Karnataka, India; mathad.kwr@gmail.com |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "After screening, students were randomly allocated into two groups." Quote: "Meanwhile, normality test (Shapiro‐Wilk) ensured that there is no significant difference between yoga and WLC groups at baseline for all the variables." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; verified baseline comparability for several sociodemographic characteristics (age, gender, marital status, residence); baseline comparability for other sociodemographic variables (class/batch; religion, mother tongue) (i.e. statistical (non‐)significance) not specified; no significant baseline differences in outcome variables (see Table 4; all Ps > 0.18) |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement comment: insufficient information about blinding of outcome assessment; but due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "100 students were recruited, 50 participants in each group and there were 10 dropouts in each group. Finally, for analysis there were 80 students left." Judgement comment: reasons for missing data unlikely to be related to true outcome with relative balance in number and reasons for missing data between groups (IG: 10 dropouts; CG: 10 dropouts; e.g. IG: 3 not willing to attend vs 4 in CG; IG: 2 excluded during data analysis vs 1 in CG; IG: 2 could not attend intervention due to personal reasons vs 2 in CG who discontinued the course); per‐protocol analysis (i.e. only participants who did not drop out from IG or CG) |
| Selective reporting (reporting bias) | Low risk | Judgement comment: no study protocol or trial registration available but it is clear that the published reports include all expected outcomes, including those that were prespecified |