scholarly journals Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a Randomized Controlled Trial and Implementation Evaluation

2020 ◽  
Author(s):  
Abhimanyu Sud ◽  
Michelle L. A. Nelson ◽  
Darren K. Cheng ◽  
Alana Armas ◽  
Kirk Foat ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Pain Clinic ◽  
Care Providers ◽  
Opioid Use ◽  
Implementation Evaluation ◽  
Randomized Controlled

Abstract Background: Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the healthcare system. Methods: We will conduct a hybrid type 1 effectiveness-implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial (RCT) comparing Sahaj Samadhi Meditation (SSM) versus the Health Enhancement Program (HEP) in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain related function, opioid use, and quality of life will be the secondary outcomes. The primary endpoint will be at 12 weeks with a secondary endpoint at 24 weeks to measure sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban centre in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated health care providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. Discussion: Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability. Trial Registration: ClinicalTrials.gov: NCT04039568, registered July 31, 2019. https://clinicaltrials.gov/ct2/show/NCT04039568

scholarly journals Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a Randomized Controlled Trial and Implementation Evaluation

2020 ◽  
Author(s):  
Abhimanyu Sud ◽  
Michelle L. A. Nelson ◽  
Darren K. Cheng ◽  
Alana Armas ◽  
Kirk Foat ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Pain Clinic ◽  
Clinical Environment ◽  
Opioid Use ◽  
Urban Centre ◽  
Implementation Evaluation ◽  
Randomized Controlled

Abstract Background: Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the healthcare system. Methods: We will conduct a hybrid type 1 effectiveness-implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial (RCT) comparing Sahaj Samadhi Meditation (SSM) versus the Health Enhancement Program (HEP) in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain related function, opioid use, and quality of life will be the secondary outcomes. The primary endpoint will be at 12 weeks with a secondary endpoint at 24 weeks to measure sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban centre in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated healthcare providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. Discussion: Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability. Trial Registration: ClinicalTrials.gov: NCT04039568, registered July 31, 2019. https://clinicaltrials.gov/ct2/show/NCT04039568

scholarly journals Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a Randomized Controlled Trial and Implementation Evaluation

2020 ◽  
Author(s):  
Abhimanyu Sud ◽  
Michelle L. A. Nelson ◽  
Darren K. Cheng ◽  
Alana Armas ◽  
Kirk Foat ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Pain Clinic ◽  
Clinical Environment ◽  
Opioid Use ◽  
Urban Centre ◽  
Implementation Evaluation ◽  
Randomized Controlled

Abstract Background: Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the healthcare system. Methods: We will conduct a hybrid type 1 effectiveness-implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial (RCT) comparing Sahaj Samadhi Meditation (SSM) versus the Health Enhancement Program (HEP) in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain related function, opioid use, and quality of life will be the secondary outcomes. The primary endpoint will be at 12 weeks with a secondary endpoint at 24 weeks to measure sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban centre in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated healthcare providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. Discussion: Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability.

scholarly journals Does mhGAP training of primary health care providers improve the identification of child- and adolescent mental, neurological or substance use disorders? Results from a randomized controlled trial in Uganda

2018 ◽  
Vol 5 ◽  
Author(s):  
A. Akol ◽  
F. Makumbi ◽  
J. N. Babirye ◽  
J. S. Nalugya ◽  
S. Nshemereirwe ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Health Care ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Child And Adolescent ◽  
Care Providers ◽  
Randomized Controlled ◽  
Primary Health

Background.Integrating child and adolescent mental health (CAMH) into primary health care (PHC) using the WHO mental health gap action program (mhGAP) is recommended for closing a mental health treatment gap in low- and middle-income countries, but PHC providers have limited ability to detect CAMH disorders. We aimed to evaluate the effect of PHC provider mhGAP training on CAMH disorder identification in Eastern Uganda.Methods.Thirty-six PHC clinics participated in a randomized controlled trial which compared the proportion of intervention (n= 18) to control (n= 18) clinics with a non-epilepsy CAMH diagnosis over 3 consecutive months following mhGAP-oriented CAMH training. Fisher's exact test and logistic regression based on intention to treat principles were applied. (clinicaltrials.gov registration NCT02552056).Results.Nearly two thirds (63.8%, 23/36) of all clinics identified and recorded at least one non-epilepsy CAMH diagnosis from 40 692 clinic visits of patients aged 1–18 recorded over 4 months. The proportion of clinics with a non-epilepsy CAMH diagnosis prior to training was 27.7% (10/36, similar between study arms). Training did not significantly improve intervention clinics’ non-epilepsy CAMH diagnosis (13/18, 72.2%) relative to the control (7/18, 38.9%) arm,p= 0.092. The odds of identifying and recording a non-epilepsy CAMH diagnosis were 2.5 times higher in the intervention than control arms at the end of 3 months of follow-up [adj.OR 2.48; 95% CI (1.31–4.68);p= 0.005].Conclusion.In this setting, mhGAP CAMH training of PHC providers increases PHC clinics’ identification and reporting of non-epilepsy CAMH cases but this increase did not reach statistical significance.

scholarly journals Comparative maternal outcomes of oral nifedipine and intravenous labetalol for severe hypertension during pregnancy: an open label randomized controlled trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2847
Author(s):  
Monika Sharma ◽  
Sita Thakur ◽  
Kamal Singh ◽  
Shashank Shekhar
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Health Care Providers ◽  
Severe Hypertension ◽  
Controlled Trial ◽  
Care Providers ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Hypertensive Diseases

Background: Hypertensive diseases are commonly seen during pregnancy and remain one of the leading causes of maternal morbidity and mortality. Mostly commonly preferred drugs by health care providers for treatment of severe hypertension during pregnancy are labetalol and hydralazine. However, they require proper storage, intravenous access, and adequately trained staff for usage. Oral nifedipine in contrast is easier to use and widely available.  Objective of this study was to report the efficacy and safety of oral nifedipine as compared to intravenous labetalol for treatment of severe hypertension during pregnancy.Methods: It was an open label randomized controlled trial in which 100 women with severe hypertension during pregnancy were enrolled. They were randomized to receive either incremental doses of intravenous labetalol every 20 minutes (total 300 mg) or 10 mg oral nifedipine every 20 minutes (up to 50 mg) to lower the blood pressure to safer levels.Results: Women receiving oral nifedipine took significantly less time to achieve target blood pressure [(37.6±23.3) minutes (SD) as compared to those receiving intravenous labetalol (52.0 minutes±27.95 (SD)]. Women receiving nifedipine for treatment also required significantly lesser doses to control the blood pressure [mean dose 1.8±1.1 (SD) versus 2.6±1.2 (SD) p=0.006]. There were two failures in labetalol group and one failure in nifedipine group. No serious adverse events were reported in either group.Conclusions: Oral nifedipine is equally efficacious to I.V. labetalol for treatment of severe hypertension during pregnancy and is easier to use in low resource settings.

scholarly journals A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jennifer A. Rabbitts ◽  
Chuan Zhou ◽  
Rocio de la Vega ◽  
Homer Aalfs ◽  
Caitlin B. Murray ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Spinal Fusion ◽  
Acute Pain ◽  
Controlled Trial ◽  
Opioid Use ◽  
Cognitive Behavioral Intervention ◽  
Postsurgical Pain ◽  
Randomized Controlled ◽  
Chronic Postsurgical Pain

Abstract Background Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict higher acute pain and likelihood of developing chronic postsurgical pain. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery. Methods Adolescents 12–18 years of age undergoing spinal fusion for idiopathic conditions, and their parent, will be recruited from pediatric centers across the USA, for a target complete sample of 400 dyads. Adolescents will be randomized into 4 study arms using a factorial design to SurgeryPalTM or education control during 2 phases of treatment: (1) pre-operative phase (one-month before surgery) and (2) post-operative phase (1 month after surgery). Acute pain severity and interference (primary acute outcomes) and opioid use will be assessed daily for 14 days following hospital discharge. Chronic pain severity and interference (primary acute outcomes), as well as HRQL, parent and adolescent distress, sleep quality, and opioid use/misuse (secondary outcomes), will be assessed at 3 months and 6 months post-surgery. Discussion Demonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery. Trial registration NCT04637802 ClinicalTrials.gov. Registered on November 20, 2020

The Role of Docusate for Constipation in Older People

2021 ◽  
Vol 36 (10) ◽  
pp. 501-507
Author(s):  
Timothy Nguyen
Keyword(s):  
Randomized Controlled Trial ◽  
Older People ◽  
Older Adult ◽  
Health Care Providers ◽  
Chronic Constipation ◽  
Data Extraction ◽  
Controlled Trial ◽  
Adult Population ◽  
Care Providers ◽  
Randomized Controlled

Objective: To provide brief information on the effectiveness of docusate use for constipation in older people. Data Sources: PubMed search using the following terms (“docusate and chronic constipation,” “docusate, chronic constipation and geriatric,” “docusate, chronic constipation and older adult,” “docusate and randomized controlled trial” and included relevant information related to docusate and chronic constipation in the population described. Study Selection: Studies that fit the criteria for “chronic/general constipation,” “geriatric/older adults,” and/or “randomized controlled trials” were included. Four studies described docusate for chronic/general constipation and older people. Not included were other studies not related to chronic/general constipation and older people (eg, surgery-related). Data Extraction: Data extraction from each study included primary outcomes related to chronic constipation and efficacy of docusate. Data also included relevant reports from other relevant trials and discussions. Data Synthesis: Docusate when compared with placebo or psyllium or sennosides in these trials did not show any benefits for constipation. Psyllium and sennosides showed to be more effective compared with docusate. No differences found between docusate versus placebo. In summary, there is a lack of data to support the use of docusate for constipation and the data presented that docusate is not effective for use in constipation. Conclusion: Docusate is commonly used for constipation despite little evidence supporting its efficacy. There is not enough randomized controlled trial and data to support the use of docusate for constipation. Pharmacists along with health care providers should reassess and reconsider whether to use it and add extra layers to an already complex medication regimen in the older adult population.

Patient and provider perspectives on home telecare: Preliminary results from a randomized controlled trial

2005 ◽  
Vol 11 (1_suppl) ◽  
pp. 95-97 ◽  
Author(s):  
F S Mair ◽  
P Goldstein ◽  
C May ◽  
R Angus ◽  
C Shiels ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Care Providers ◽  
North West ◽  
Randomized Controlled ◽  
The North ◽  
Provider Perspectives

A randomized controlled trial of home telecare for the management of acute exacerbations of chronic obstructive pulmonary disease has been undertaken in the north-west of England. A videophone was used that communicates via the ordinary telephone network. The intervention period for each participant was two weeks. Participants in the telecare arm of the trial were asked to complete logbooks to record their experiences of each telecare encounter. A simple, self-completed, 10–item questionnaire was used that consisted of a Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Fourteen nurses completed 150 logbooks and 22 patients completed 145 logbooks. These results demonstrate significant differences in perception between patients and their health-care providers with regard to telecare encounters across all the domains addressed. Participating patients consistently demonstrated more positive views of the telecare encounters than their health-care providers.

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