METHODS: A participant blinded, multi-centre, randomised controlled trial was conducted in which the participants in the intervention group (IG) practiced deep breathing exercise guided by sound cues and those in the control group (CG) listened to the music. The primary end point was reduction in blood pressure at eight weeks.
RESULTS: 87 patients, 46 males and 41 females with mean age of 61.1 years were recruited and 93.1% of them successfully completed the study. There was significant reduction in systolic and diastolic Blood Pressure from baseline by 8 weeks in both groups. The reduction in Mean systolic blood pressure (SBP) in the control arm was 10.5mmHg compared to 8.3mmHg (p<0.001) in intervention group. Diastolic blood pressure (DBP) reduction in control and intervention groups were 5.2 mmHg (p<0.001) and 5.6 mmHg (p<0.001) respectively. The absolute difference in SBP reduction from baseline in IG & CG was -2.2 (95%CI: -7.8 to 3.5) and DBP was -0.4 (95%CI: -2.9 to 3.6). However, blood pressure reduction between the two groups was not significant.
CONCLUSIONS: Both listening to music and deep breathing exercise were associated with a clinically significant reduction in SBP and DBP. However, deep breathing exercise did not augment the benefit of music in reducing BP.
MATERIALS AND METHODS: A cross-over study was conducted in 2 phases of 6 weeks duration each with an intervening 2-week washout. Twenty-five participants meeting inclusion criteria were randomly allocated into groups A (13) and B (12). In phase 1: group A was assigned T1 and group B was assigned T2. Toothbrushing was advised twice daily for 2 minutes by modified bass technique after meals. At baseline, 3 weeks and 6 weeks the wear index (WI), plaque index (PI) and gingival index (GI) were recorded. Following washout in phase 2 group A was assigned T2 and group B was assigned T1 and the same study protocol was followed.
RESULTS: Intra-group comparison between baseline, 3 and 6 weeks by the paired t-test resulted in significant reduction in PI, GI and increase in WI (p <0.05) for T1 and T2. Inter-group comparison using the unpaired t-test resulted in WI for T1 being significantly higher (p <0.05) at 3 weeks and lower at 6 weeks (p <0.05) compared to T2. PI for T1 was significantly higher at 3 weeks (p <0.05) and lower at 6 weeks (p <0.05) compared to T2. No significant difference in GI scores between T1 and T2 at 3 and 6 weeks was observed (p >0.05).
CONCLUSION: Charcoal infused bristles demonstrated less wear and more plaque removal compared to nylon bristles.
CLINICAL SIGNIFICANCE: Charcoal infused bristles demonstrate less wear compared to nylon bristles.
METHODOLOGY: The study will be a single-blind parallel-group randomised controlled trial, where baseline data will be collected from 392 estimated antenatal mothers, after that they will be evenly randomised using randomly generated permuted block sizes (each containing two intervention and two control assignments). The study participants will be antenatal mothers of ages 18 years and above who are in third trimesters and attending Federal Medical Centre Gusau, Zamfara State, Nigeria; during the study period and fulfilled all the inclusion and exclusion criteria. The intervention group will undergo five-health education sessions on immunisation, which will be strictly guided by Social Cognitive Theory-based intervention module: while the control group will receive usual care (standard care). Follow-up data will be collected using the same questionnaire at 6-weeks post-delivery, 10-weeks post-delivery and 14-weeks post-delivery. The generalized linear mixed model will be carried-out to determine the overall effect of the intervention after controlling for 14 potential confounding variables. An intention to treat analysis will also be carried-out. Childhood immunisation uptake is the primary outcome while the secondary outcomes are: improved knowledge scores, attitude scores, outcomes expectation, self-efficacy scores, cultural beliefs scores and assumptions on religious regulations scores.
DISCUSSION: The study will be a randomised controlled trial, that focuses on the effects of an immunisation health educational intervention with application of Social Cognitive Theory on pregnant women to improve knowledge, attitude, outcome expectations, self-efficacy, cultural beliefs and assumptions on religious regulations regarding childhood immunisation uptake in Federal Medical Centre Gusau, Zamfara State, Nigeria.
TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202006722055635. Protocol registered on 09 June 2020.