F. SVYASA Dissertations
Permanent URI for this communityhttps://elibraryofyoga.com/handle/123456789/26
Yoga Dissertations by Yoga Students at SVYASA. These pages present some efforts of SVYASA at Scientific Validation of Yoga, combining the best of the East with the best of the West
News
Yoga Dissertations
Browse
503 results
Search Results
Item Evaluating the effect of single auriculotherapy point for large intestine among indivisuals with functional constipation - A randomized control trial(S-VYASA, 2026-05-13) Shaik Saba Banu; Kavana.G; Moulya K Appanna; Pallavi VBACKGROUND: Functional constipation is one of the most common gastrointestinal disorders affecting young adults and university students due to poor dietary habits, low fiber intake, inadequate hydration, stress, sedentary lifestyle, and irregular bowel habits. It is characterized by infrequent bowel movements, hard stools, straining during defecation, abdominal bloating, and a feeling of incomplete evacuation. Although conventional management such as laxatives and dietary modifications provides temporary relief, prolonged use may cause side effects including bloating, abdominal cramps, and dependency. Therefore, there is an increasing need for safe, simple, and non-invasive complementary therapies. Auriculotherapy, a branch of Traditional Chinese Medicine (TCM), is based on stimulation of specific auricular points corresponding to internal organs and body systems. The Large Intestine auricular point is believed to regulate intestinal motility, improve bowel function, and restore the flow of Qi, thereby relieving constipation symptoms. AIM: To evaluate the effectiveness of single-point auriculotherapy at the Large Intestine auricular point in improving symptoms of functional constipation among young adults. METHODS: This randomized controlled trial included 60 participants aged between 18 and 25 years diagnosed with functional constipation. Participants were randomly divided into two groups: Experimental Group (Group A) and Control Group (Group B), with 30 participants in each group. The experimental group received press needle auriculotherapy at the Large Intestine auricular point, while the control group received sham auriculotherapy using adhesive plaster without active stimulation. The intervention was administered three sessions per week for four weeks. Baseline assessments were recorded before the intervention, and post-intervention assessments were conducted after completion of the four-week treatment period. ASSESSMENT: Bowel function and constipation severity were assessed using standardized outcome measures. Bowel movement frequency was evaluated using a daily Bowel Diary. Constipation severity was assessed using the Constipation Assessment Scale (CAS), which included symptoms such as abdominal bloating, hard stool, straining, rectal fullness, and incomplete evacuation. Abdominal discomfort and symptom severity were measured using the Visual Analogue Scale (VAS), with scores ranging from 0 to 10. RESULTS: The study demonstrated significant improvement in constipation symptoms following single-point auriculotherapy intervention. CAS scores and bowel movement frequency showed highly significant improvement after four weeks of intervention (p < 0.001), indicating reduced constipation severity and improved bowel habits. The experimental group showed better clinical improvement compared to the control group. VAS scores showed mild improvement in abdominal discomfort, although the changes were not statistically significant. The observed improvement may be associated with activation of the vagus nerve and autonomic nervous system modulation, which enhances intestinal motility and colon peristalsis. CONCLUSION: Single-point auriculotherapy at the Large Intestine auricular point may serve as a safe, simple, cost-effective, and non-invasive complementary therapy for managing functional constipation among young adults. The findings suggest that auriculotherapy effectively improves bowel movement frequency and reduces constipation severity, thereby contributing to better bowel health and quality of life. Further studies with larger sample sizes and longer follow-up periods are recommended to establish long-term effectiveness and broader clinical applicability. KEYWORDS: Functional Constipation, Auriculotherapy, Large Intestine Point, Traditional Chinese Medicine (TCM), Bowel Movement Frequency, Constipation Assessment Scale, Visual Analogue Scale, Young Adults, Complementary Therapy.Item Evaluating neural activation changes following figure of eight walk training in parkinson's disease using fNIRS Pre-post observational study(S-VYASA, 2026-05-13) Tejaswini R; T Srujana; Sharad Shivajirao Chaudhari; Krishna Dwivedhi; Arundathi GoleyBackground: Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by impaired motor control, particularly during complex gait activities. Figure-of-eight walking (infinity walk) is a dynamic locomotor task that challenges balance, coordination, and motor planning. Functional near-infrared spectroscopy (fNIRS) enables real-time assessment of cortical hemodynamic responses during such functional movements. Objective: To evaluate the immediate effect of figure-of-eight walking on cortical activation, measured through changes in oxygenated (HbO) and deoxygenated hemoglobin (HbR), in individuals with Parkinson’s disease. Methods: A single-group, within-subject experimental study was conducted on 11 participants diagnosed with Parkinson’s disease. Baseline cortical activity was recorded using fNIRS during rest, followed by recording during and after the figure-of-eight walking task. Hemodynamic parameters including HbO, HbR, and total hemoglobin were analyzed. Normality of data was assessed using the Shapiro–Wilk test, and paired sample t-tests were applied to compare pre- and post-intervention values. Results: All variables were normally distributed (p > 0.05). Paired t-test analysis revealed no statistically significant differences between pre- and post-intervention values for HbO (p = 0.378), HbR (p = 0.397), and total hemoglobin (p = 0.627). Effect size analysis indicated small effect sizes across all variables. However, qualitative observation of fNIRS topographical maps demonstrated increased and more symmetrical cortical activation patterns following the intervention. Conclusion: Figure-of-eight walking did not produce statistically significant changes in cortical hemodynamics in this sample. However, observed trends in cortical activation suggest potential neural engagement and compensatory cortical recruitment. Further studies with larger sample sizes and longer intervention durations are recommended to better elucidate the neurophysiological effects of complex gait training in Parkinson’s disease. Keywords: Parkinson’s disease, fNIRS, figure-of-eight walking, cortical activation, oxyhemoglobin, gait analysisItem Effect of cyclic meditation on changes of Iris and perceived stress among college going students: A pilot observational study(S-VYASA, 2026-05-13) Lavanya M. R.; Titty GeorgeBACKGROUND: Stress has been defined as a state of mental or emotional strain due to adverse or challenging circumstances. (Agyapong et al., 2023)The ability to adapt to stress is crucial for maintaining homeostasis and, consequently, for sustaining life.(Chaves et al., 2021).The rising incidence of stress-related disorders highlights the necessity for further research into stress adaptation, there are two primary regulatory pathways: the hypothalamic-pituitary-adrenocortical axis and the sympathetic-adrenomedullary axis. These pathways work together, supported by the significant bidirectional connections between their respective centers, the paraventricular nucleus of the hypothalamus (PVN), and the brainstem monoaminergic cell groups. The PVN, particularly its corticotropin-releasing hormone (CRH) producing neurons, is regarded as the central hub for stress regulation.(Chaves et al., 2021) AIM: • To assess the impact of 'Cyclic Meditation' practice on iris changes and perceived stress among college students. OBJECTIVE: The objective of the study is: • To study the effect of cyclic meditation on the iris. • To study the effect of cyclic meditation on perceived stress • To evaluate the common changes in iris pattern in stressed individuals. MATERIALS AND METHODS: Participants: College going students of age 18 to 25 years. The proposed study was a Pilot observational study with a total of 34 subjects who were pre assessed and selected. Design: A total of 34 subjects were screened and sample were based on inclusion and exclusion criteria. before the intervention consent form is taken. Assessments: • Iris parameters • Perceived Stress Scale (PSS) Intervention: • Yoga- Cyclic Meditation will be given as intervention daily one time for about 30minutes duration for 60 days. RESULTS: There is statistically significant difference between pre data and post data which suggests that yogic cyclic meditation is effective. Significant improvement was seen in PSS scoring and P value (less than 0.05) CONCLUSION: Cyclic Meditation has an effect on stress rings in the iris, as well as a reduction in perceived stress levels measured by the PSS-10 questionnaire and is effective in improving quality of life and reducing stress in individuals. KEYWORDS: Yoga, Iridology, Cyclic meditation, StressItem Glycemic and physiological responses in healthy adults following 1008 surya namaskar: A time dependent pre-post CGM study.(S-VYASA, 2026-05-13) Nandini Priya; Dasari Navya Sindhuri; H. R. Nagendra; Sharad Shivajirao ChaudhariBackground: Surya Namaskar is a classical yogic practice integrating physical movement, breath regulation, and metabolic activation. While its general health benefits are known, the acute glycemic and physiological responses to performing 1008 Surya Namaskar remain underexplored, particularly using continuous glucose monitoring (CGM). Aim: To evaluate the time-dependent glycemic variability and physiological responses in healthy adults following the performance of 1008 Surya Namaskar using continuous glucose monitoring (CGM) and pre– and post–assessment. Methods: A pre–post experimental study was conducted on 52 healthy adults. CGM readings were recorded at nine break intervals during the session. Pre- and post-intervention parameters included random blood glucose (GRBS), blood pressure (SBP, DBP), oxygen saturation (SpO₂), body weight, and breath-holding capacity (Kumbhaka). Repeated measures analysis with appropriate corrections was used to evaluate changes across time points, along with paired and non-parametric tests for pre–post comparisons. Assessment: Continuous glucose monitoring was performed at nine break intervals, along with pre and post–measurements of random blood glucose, blood pressure, oxygen saturation (SpO₂), body weight, and breath-holding capacity (Kumbhaka). Results: A significant variation in glucose levels was observed across the nine break intervals, demonstrating marked glycemic variability during the session. The CGM revealed a biphasic pattern, with an initial decline followed by a progressive rise, reaching peak levels toward the final phase. Pre–post analysis showed an increase in blood glucose levels along with improvements in oxygen saturation and breath-holding capacity. A measurable change in body weight was also observed following the session. Conclusion: The 1008 Surya Namaskar induces significant time-dependent glycemic fluctuations and acute physiological adaptations in healthy individuals. The biphasic glucose response reflects enhanced metabolic activity, involving increased peripheral utilization followed by compensatory glucose mobilization. These findings highlight Surya Namaskar as a potent metabolic stimulus influencing glucose regulation and respiratory efficiency. Keywords: Surya Namaskar, Continuous Glucose Monitoring, Glycemic Variability, Yoga, Acute Exercise Response, Kumbhaka, SpO₂.Item Effects of Bhagavad Gita shloka chanting on autonomic and cognitive functions in college students(S-VYASA, 2026-05-13) Mithra Raja; Puja Kumari Mandal; Sridevi K. J.; Krishna DwivediBackground: Bhagavad Gita chanting is a traditional yogic practice involving rhythmic recitation, controlled breathing, focused attention, and memorization. Previous studies on mantra chanting have demonstrated beneficial effects on autonomic regulation, cognitive abilities, and emotional well-being through modulation of the autonomic nervous system and Heart Rate Variability (HRV). Bhagavad Gita shlokas are traditionally believed to enhance mental clarity, concentration, and inner stability. However, limited scientific evidence exists regarding the effects of structured Bhagavad Gita shloka chanting and memorization on autonomic functions, cognitive abilities, and anxiety among young adults. Aim: To explore the effect of chanting and memorizing the Bhagavad Gita Shlokas on autonomic and cognitive functions (Attention and Mindfulness) in college students. Objective: 1. To explore the effect of an 8-week Bhagavad Gita shloka chanting on autonomic nervous system functioning using HRV as a biomarker. 2. To explore the effect of an 8-week Bhagavad Gita shloka chanting on cognitive abilities such as attention and mindfulness. 3. To assess changes in anxiety levels before and after the 8-week of Bhagavad Gita shloka chanting. MATERIALS AND METHODS: Participants: A total of 30 college-going students of the age group 18-25 years were recruited based on convenience sampling (Voluntary Participation). Design: Participants who expressed interest in the study were first screened using the predefined inclusion and exclusion criteria. Thirty eligible participants were selected, after which written informed consent was obtained prior to participation. Assessments: Baseline assessments included Heart Rate Variability parameters such as RMSSD, SDNN, HF, LF, and LF/HF ratio, along with cognitive and psychological assessments using the Six Letter Cancellation Task (SLCT), Mindfulness Attention Awareness Scale (MAAS), and State-Trait Anxiety Inventory Form Y-2 (STAI-Y2). Post-intervention assessments were conducted following completion of the intervention. Intervention: The intervention consisted of chanting and memorizing 20 shlokas from the Bhakti Yoga chapter of the Bhagavad Gita, divided into four padas for systematic learning, practiced for 30 minutes daily, 6 days a week, for 8 weeks, with the first 20 days focused on learning along with chanting and the remaining period dedicated to revision and memorization. Results: Statistically significant changes were observed in cognitive assessments, including mindfulness and attention, as well as in HRV parameters such as SDNN, LF, and LF/HF ratio following the intervention. However, RMSSD, HF, and anxiety scores did not show significant changes. Conclusion: The findings support chanting as a simple and effective mind–body intervention; however, further studies with larger sample sizes, longer intervention duration, and controlled designs are required to validate and generalize these results.Item Effect of Yogic Pranic Energization Technique on Stress, Heart Rate Variability and Cognition in Healthy College Students - A Randomized Control Trial(S-VYASA, 2026-05-13) Arudhra K; Anoop D S; Moodala Girishankara K S; Ranjinimurthy PBACKGROUND Yogic Pranic Energisation Technique (YPET) is a guided meditative practice in which one's own prana Shakthi is used for energising the body. Thus, every part of the body will be revitalised. This technique is mainly given to people who are suffering from cancer, chronic fatigue syndrome, etc. This practice integrates deep relaxation, breath awareness, and visualisation of pranic flow through the body, and is believed to regulate autonomic function. It helps to strengthen the immune defence and to revitalise the entire body. It cleanses the entire respiratory tract and purifies the subtle channels of Prana. The breathing will be balanced through Nadishudhi Pranayama, which is one of the steps in this technique. This brings balance and rhythm to the breathing pattern. Thus, there will be balance in the ida and pingala Nadi, which in turn activates the sushumna Nadi through which the energy flows properly. Heart Rate Variability (HRV) is assessed as the primary variable to see the autonomic changes in the YPET group & Supine rest group before and after the intervention, and compare both the experimental group and the control group. The Stroop test is used to assess cognition in both the experimental and control groups. AIM The study aims to assess the effect of YPET on Heart Rate Variability, Cognition & Stress in healthy college students. OBJECTIVES • Compare pre and post–changes in the YPET group • Compare the experimental group (YPET) vs. the control group (Supine rest) MATERIALS AND METHODS Subjects: • A total of 100 people in the age group 18-25 years were screened for the study. Source of subjects: • Students aged 18-25 years. (Students from S-VYASA University pursuing UG). Sample size: • Recommended total sample size was N=100 (Experimental group n= 35, Control group n=35; Excluded n= 30). Design: The design of the study was Randomized control trial. A total of 100 participants were screened, and 30 were excluded on the basis of exclusion criteria. 70 participants were randomly assigned to both experimental and control groups using chit method. The total duration of the intervention was 3 months. The data was collected before and after the intervention. Assessments: • Primary Variable- Heart Rate Variability (HRV) • Secondary Variable- Stroop test, Perceived Stress Scale (PSS) Intervention: • Participants in the experimental group practised the Pranic Energisation Technique for 30 days for 30 minutes. • Participants in the control group rested in a supine position for 30 days for 30 minutes. Results: Of 70 Healthy College students, all the subjects completed the study. No adverse events were observed during the study period. The mean ± standard deviation age in the PET group was 19.4 ± 1.91 years, whereas in the CG was 20.5 ± 1.72 years. Overall, the Study Group (PET group) has shown significant changes in HRV, Cognition and PSS scores across all variables in comparison to the Control Group. Baseline HRV parameters in both groups did not show any significant difference. The students paired t-test was used to find the changes within the group. Within the group analysis, the intervention group has shown statistical significance (P < 0.05) in Average RR (P = 0.05) and SD rate (P = 0.038), whereas the CG did not show any significant changes. The independent ttest was used to find the changes between the two groups. It showed significant (P < 0.05) improvement in Average RR (P = 0.008) and Average rate (P = 0.02) in the PET group after 30 days of practice. In the Cognitive Stroop test, the Accuracy rate and Reaction time in the study group showed statistical significance (P<0.05), which is not shown in the Control group. Between-group analysis showed that Accuracy and Reaction time were highly significant (P < 0.05). In PSS, it shows that the PSS has significantly reduced after the Practice of PET than SR. Conclusion: The results of the study suggest that YPET significantly reduces stress, improves HRV, and enhances cognition. It’s a safe, cost-effective intervention, useful for the student population.Item A Pilot Randomised Crossover Study Comparing Deep Relaxation Technique and Raga Neelambari Music on Sleep Quality in Sleep-Deprived Young Adults(S-VYASA, 2026-05-13) Soujanya Nandi; Harshit Khandelwal; Vaishali Mathapati; Titty GeorgeBACKGROUND: Sleep plays a crucial role in maintaining physical and mental health. However, many individuals experience poor sleep quality, increased daytime sleepiness, and fatigue due to stress and lifestyle factors. Non-pharmacological interventions such as relaxation techniques and music therapy have shown potential benefits in improving sleep-related outcomes. This study aimed to evaluate the effectiveness of Deep Relaxation Technique (DRT) and Raga Neelambari (RN) in improving sleep quality and reducing fatigue. OBJECTIVES: To evaluate and compare the effectiveness of Deep Relaxation Technique and Raga Neelambari on improving sleep quality. TRIAL DESIGN: 1. To assess changes in sleep quality, daytime sleepiness, and fatigue before and after interventions using PSQI, ESS, and FSS. 2. To compare the effectiveness of DRT and RN in improving these outcomes. 3. To identify which intervention produces greater improvement. METHODS: A crossover interventional study was conducted on 40 participants. Participants received both Deep Relaxation Technique and Raga Neelambari interventions in two phases with a washout period in between. Each intervention was administered over a period of 5 weeks. Outcome measures including Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale (FSS) were assessed before and after each intervention. PARTICIPANTS: young adults aged 18-25 years, (N=40) with self-reported poor sleep quality (PSQI score more than or equal to 5), recruited from S-Vyasa university, Bangalore. INTERVENTIONS: Group 1: Deep Relaxation Technique (DRT)- guided muscle relaxation with breath awareness, 20 minutes/session, 6 days/week for 2 weeks. Group 2: Raga Neelambari Music Therapy (RN)- pre-recorded classical Indian raga, 10 minutes/session, 6 days/week for 2 weeks. Both groups crossed over after a 7-day washout period. OUTCOMES: Primary outcome: Pittsburgh Sleep Quality Index. Secondary outcomes: Daytime sleepiness scale (ESS) and Fatigue severity scale (FSS), assessed pre-mid-post interventions. RESULT: The Deep Relaxation Technique showed statistically significant improvement in sleep quality, daytime sleepiness, and fatigue (p < 0.001). In contrast, Raga Neelambari did not show significant improvement in any of the measured outcomes (p > 0.05). Between-group comparison revealed that DRT was significantly more effective than RN in improving ESS (p < 0.01) and FSS (p < 0.01), while PSQI showed improvement but was less significant after correction. Overall, DRT demonstrated superior effectiveness compared to RN. CONCLUSION: Deep Relaxation Technique is an effective non-pharmacological intervention for improving sleep quality and reducing daytime sleepiness and fatigue. It was found to be more effective than Raga Neelambari. These findings support the use of relaxation techniques as a simple, safe, and cost-effective approach for managing sleep-related problems.Item Effect of Acupuncture on Haemoglobin and Fatigue Level in Anaemic Females.(S-VYASA, 2026-05-07) Himani Jagdish Shahare; Sridevi. K.JBackground: Low haemoglobin levels are associated with reduced oxygen-carrying capacity of blood, leading to symptoms such as fatigue, dizziness, reduced physical performance and poor concentration. Conventional treatment mainly involves iron supplementation; however, side effects are common. Acupuncture has been suggested to improve blood circulation and stimulate physiological processes that may support haemoglobin production and reduce fatigue. Aim: Evaluate the effect of acupuncture on haemoglobin levels and fatigue among anaemic females aged 20–24 years at S-VYASA, Bangalore. Method: Participants with mild to moderate anaemia received acupuncture at selected points (GB39, UB17, LIV13, SP6) for 15 days. Haemoglobin levels and fatigue scores were assessed before and after the intervention to determine the effectiveness. Results: A significant improvement in haemoglobin levels and reduction in fatigue scores were observed following the intervention. Conclusion: Acupuncture may be an effective complementary approach for improving haemoglobin levels and reducing fatigue. Keywords: Acupuncture, Haemoglobin, FatigueItem Effect of scalp acupuncture at Po-Shen and Shen -Hun on sustained attention in healthy young adults: A Pilot Randomized control trial(S-VYASA, 2026-05-06) Mirunalini V.; Chandrika, Chaudhary; MonicaasunBackground: In the current digital era, increased exposure to short-form media has contributed to a reduced ability to maintain prolonged focus on tasks. Sustained attention is essential for effective task performance and daily functioning. Scalp acupuncture, a non- invasive approach from Traditional Chinese Medicine, targets specific regions such as the Po-Shen and Shen-Hun bands associated with attention regulation. However, its effect on sustained attention in healthy individuals remains insufficiently explored. Aim: The study aimed to evaluate the effect of scalp acupuncture at the Po-Shen and Shen- Hun bands on sustained attention in healthy young adults. Objectives: The primary objective was to assess changes in sustained attention following scalp acupuncture. The secondary objective was to evaluate changes in cognitive function after the intervention. Materials and Methods: A pilot randomized controlled trial design was adopted. A total of 32 healthy participants aged 18–25 years were recruited and screened using the Mini-Mental State Examination (MMSE). Eligible participants (MMSE >27) were randomly allocated into intervention (n=16) and control (n=16) groups. The intervention group received scalp acupuncture at Po-Shen and Shen-Hun bands, while the control group received sham acupuncture. The intervention was administered for two blocks of 10 consecutive days with a 5-day interval. Sustained attention and cognitive performance were assessed before and after the intervention using the Sustained Attention Response Task (SART) and the Stroop Colour and Word Test (SCWT). Data were analyzed using JAMOVI (2.7.26) Was used for statistical analysis. Participants: Thirty-two healthy young adults from a university setting who met inclusion and exclusion criteria and provided informed consent were included in the study. Study Design: This study was a pilot randomized controlled trial with parallel groups and assessor- based pre- and post-intervention evaluation. Assessment Tools: Sustained attention was assessed using the SART (sustained attention response task), and cognitive function was evaluated using the SCWT (Stroop Colour and Word Test). Intervention: The intervention involved scalp acupuncture at the Po-Shen and Shen-Hun bands using standard needling techniques, while the control group received sham acupuncture at non-therapeutic points. Hypothesis: Scalp acupuncture would significantly improve sustained attention and cognitive performance compared to the control group. Null Hypothesis: There would be no significant difference in sustained attention or cognitive performance between the intervention and control groups. Keywords: Scalp acupuncture, sustained attention, cognition, Po-Shen, Shen-Hun, SART, Stroop test, randomized controlled trial.Item The effect of Om meditation on sleep quality in menopausal women - A randamised controlled trail(S-VYASA, 2026-05-06) Polireddy Bhavigna; NavyaBackground: Menopause is frequently associated with sleep disturbances and a range of somatic and psychological symptoms, significantly affecting quality of life. Pharmacological treatments provide relief but carry risks, highlighting the need for safe, nonpharmacological alternatives. Om meditation, rooted in yogic tradition, is known to activate the parasympathetic system and promote relaxation, potentially improving sleep quality. Objective: To evaluate the effect of Om meditation on sleep quality and menopausal symptoms in women aged 40–55 years. Methods: A randomized controlled trial was conducted with 62 menopausal women experiencing sleep disturbances. Participants were randomly assigned to an intervention group (n = 30) practicing Om meditation daily for 30 minutes over three months, or a control group (n = 32) practicing supine rest for the same duration. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), and menopausal symptoms were measured using the Menopause Rating Scale (MRS). Pre and postintervention scores were compared using paired and independent ttests, with ANCOVA applied for betweengroup analysis. Results: The intervention group demonstrated significant improvements in both PSQI (mean reduction from 7.9 to 4.1, p < 0.001) and MRS (mean reduction from 13.5 to 8.2, p < 0.001), with large effect sizes (Cohen’s d ≈ 0.80–0.88). The control group showed modest improvements (PSQI from 7.7 to 6.9; MRS from 13.0 to 12.1), which were not clinically significant. Betweengroup analysis confirmed superior outcomes in the intervention group (p < 0.01). Conclusion: Om meditation is a safe, accessible, and culturally relevant intervention that significantly improves sleep quality and reduces menopausal symptoms. Its dual impact on physiological and psychological domains highlights its potential as a supportive therapy in menopausal health management and community programs. Keywords: Om meditation, menopause, sleep quality, nonpharmacological intervention, randomized controlled trial.