scholarly journals Study protocol for the TRUSt trial: a pragmatic randomised controlled trial comparing the standard of care with a transitional pain service for patients at risk of chronic postsurgical pain undergoing surgery

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e049676
Author(s):  
Manouk Admiraal ◽  
Henning Hermanns ◽  
Jeroen Hermanides ◽  
Carin G.C.L. Wensing ◽  
Soe L. Meinsma ◽  
...  
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Opioid Use ◽  
Quality Of Recovery ◽  
Chronic Postsurgical Pain ◽  
Patients At Risk ◽  
Randomised Controlled

IntroductionPatients with either surgery-related or patient-related risk factors are at an increased risk of acute and chronic postsurgical pain (CPSP) and long-term opioid use. To improve recovery, prevent CPSP and decrease opioid use, we need to identify these patients before surgery and provide a multidisciplinary pain management strategy throughout hospital admission and follow-up in the postdischarge period. We hypothesise that a multidisciplinary transitional pain service (TPS) improves quality of recovery and reduce the incidence of CPSP and opioid consumption.Methods and analysisWe aim to investigate the effectiveness of implementation of a TPS for patients at risk of developing CPSP. The trial design is a pragmatic, open-label, randomised controlled trial (RCT). After stratification for sex, patients are randomly assigned to the TPS or standard of care (SOC) group. Our primary outcome is the quality of recovery, measured at the morning of the third postoperative day, employing the quality of recovery (QoR)-15 questionnaire. Secondary outcomes are the incidence of CPSP, opioid consumption and patient-reported outcome measures at 3 and 6 months postoperatively. We need to enrol 176 patients to detect a minimal clinical important difference of 8 points on the QoR-15 score.Ethics and disseminationEthics approval was obtained by the accredited medical research ethics committee of the Academic Medical Center in Amsterdam (2020_211) on 15 October 2020. Protocol version 3.2 was approved on 25 January 2020. The trial is registered with the Netherlands Trial Register, NL9115. The results will be disseminated by open access publication in a peer-reviewed journal.Trial registration number NL9115

scholarly journals Attempting to prevent postnatal depression by targeting the mother–infant relationship: a randomised controlled trial

2014 ◽  
Vol 16 (04) ◽  
pp. 383-397 ◽  
Author(s):  
Peter J. Cooper ◽  
Leonardo De Pascalis ◽  
Matthew Woolgar ◽  
Helena Romaniuk ◽  
Lynne Murray
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Child Development ◽  
Postnatal Depression ◽  
Controlled Trial ◽  
Maternal Sensitivity ◽  
Maternal Mood ◽  
Health Visitors ◽  
Randomised Controlled

AimThe purpose of the study was to investigate whether an intervention which focused on enhancing the quality of the mother-infant relationship would prevent the development of postnatal depression (PND) and the associated impairments in parenting and adverse effects on child development.BackgroundRecent meta-analyses indicate modest preventive effects of psychological treatments for women vulnerable to the development of PND. However, given the strong evidence for an impact of PND on the quality of the mother–infant relationship and child development, it is notable that there are limited data on the impact of preventive interventions on these outcomes. This is clearly a question that requires research attention. Accordingly, a randomised controlled trial (RCT) was conducted of such a preventive intervention.MethodsA large sample of pregnant women was screened to identify those at risk of PND. In an RCT 91 were randomly assigned to receive the index intervention from research health visitors, and 99 were assigned to a control group who received normal care. In an adjacent area 76 women at risk of PND received the index intervention from trained National Health Service (NHS) health visitors. The index intervention involved 11 home visits, two antenatally and nine postnatally. They were supportive in nature, with specific measures to enhance maternal sensitivity to infant communicative signals, including items from the Neonatal Behavioral Assessment Scale. Independent assessments were made at 8 weeks, 18 weeks, and 12 and 18 months postpartum. Assessments were made of maternal mood, maternal sensitivity in mother–infant engagement, and infant behaviour problems, attachment and cognition.FindingsThe RCT revealed that the index intervention had no impact on maternal mood, the quality of the maternal parenting behaviours, or infant outcome, although there were suggestions, on some self-report measures, that those with a lower level of antenatal risk experienced benefit. This was also the case for the intervention delivered by trained NHS health visitors. The findings indicate that the approach investigated to preventing PND and its associated problems cannot be recommended.

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