Dataset Information

Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.

ABSTRACT: BACKGROUND:During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures, yet, regarding combined multisensorial parent-driven non-pharmacological pain management, research is still lacking. METHODS/DESIGN:A multi-center randomized controlled trial (RCT) with three parallel groups with the allocation ratio 1:1:1 is planned. The RCT "Parents as pain management in Swedish neonatal care - SWEpap", will investigate the efficacy of combined pain management with skin-to-skin contact, breastfeeding and live parental lullaby singing compared with standard pain care initiated by health care professionals, during routine metabolic screening of newborn infants (PKU-test). DISCUSSION:Parental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations. To date, few studies have been published examining the efficacy of combined multisensorial parent-driven interventions. So far, research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone. Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation that keep the parent close to the infant, are more effective in a painful context. In the SWEpap study we also include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with skin-to-skin contact and breastfeeding. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT04341194 ) 10 April 2020.

SUBMITTER: Olsson E

PROVIDER: S-EPMC7549219 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.

Olsson Emma E Carlsen Misic Martina M Dovland Andersen Randi R Ericson Jenny J Eriksson Mats M Thernström Blomqvist Ylva Y Ullsten Alexandra A

BMC pediatrics 20201012 1

<h4>Background</h4>During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful pr ...[more]

PMID: 33046026

Similar Datasets

Project description:Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare.Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital.The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today's clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients.ClinicalTrials.gov Identifier NCT01651832.

Project description:BackgroundIndividuals with type 2 diabetes (T2D) who smoke are at increased risk for many types of cancers as well as an accelerated progression of microvascular and macrovascular complications. Smoking cessation is recommended as a standard treatment for T2D; however, individuals with T2D are faced with competing lifestyle changes. Glycemic and blood pressure control often take precedence over smoking cessation, and patients are often unmotivated to quit. Contingency management in combination with standard smoking cessation treatment has been demonstrated to improve cessation outcomes in various populations. The purpose of this randomized controlled feasibility trial is to explore the feasibility of contingency management and biochemical verification using a remote smartphone-based carbon monoxide monitor for smoking cessation among individuals with T2D.MethodsA three-arm, randomized controlled feasibility trial will be conducted in two study sites that include the USA and UK. We will recruit 60 participants who will each receive usual care smoking cessation treatment (counseling and nicotine replacement therapy) and be randomized to a short term incentives (6 weeks), long term incentives (12 weeks), or no incentives (control) group. Participants will receive a smartphone and carbon monoxide monitor to complete daily remote assessments throughout the 12 weeks and will complete an exit interview at the end of the study. The primary outcomes for this feasibility study include completion of the protocol and proportion of daily assessments completed. Secondary outcomes include recruitment measures, acceptability, and smoking abstinence.DiscussionWe will explore the feasibility of recruiting smokers with T2D and their engagement in the program, particularly related to the use of the remote biochemical verification and smartphone application. In addition, we will evaluate the intervention content, study procedures, data collection methods, and follow-up and will qualitatively assess the participants' acceptability of the program. The results of this study will inform the design of a larger trial to test the efficacy of the contingency management program for improving smoking cessation outcomes among individuals with T2D.Trial registrationThis randomized controlled feasibility trial has been registered at ClinicalTrials.gov with an ID NCT03527667 on May 4, 2018.

Project description:PurposePain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT).MethodsAcupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY.ResultsRecruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted.ConclusionSuccessful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED.Clinical trialsgovNCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.

Project description:BackgroundResearch has highlighted the need for evidence-based interventions to improve paediatric advance care planning (pACP) in adolescents with cancer. Although adolescents express the desire and ability to share their values, beliefs and preferences for treatment, there is a lack of structured multicomponent interventions to improve parent-adolescent communication on different ACP themes including those not limited to end-of-life care. The aim of this study is to evaluate the effectiveness and implementation, context and mechanisms of impact of a novel ACP program in paediatric oncology.MethodsWe will conduct a multi-centre parallel-group randomised controlled superiority trial with embedded mixed-methods process evaluation in Flanders, Belgium. Adolescents aged 10-18 who have cancer, and their parent(s) will be recruited via all four university hospitals in Flanders, Belgium, and support groups. Families will be randomised to receive care as usual or the multicomponent BOOST pACP program, consisting of three conversation sessions between an external facilitator and the adolescent and parent(s). The primary endpoint is improved parent-adolescent communication from the perspective of the adolescent. Secondary endpoints are adolescents' and parents' attitudes, self-efficacy, intention and behaviour regarding talking about ACP themes with each other, parents' perspective of shared decision making in the last clinical encounter, and the paediatric oncologist's intention and behaviour regarding talking about ACP themes with the family. Measurements will be performed at baseline, at 3 months and at 7 months using structured self-reported questionnaires. We will perform a process evaluation in the intervention group, with measurement throughout and post-intervention, using structured diaries filled out by the facilitators, interviews with facilitators, interviews with involved paediatric oncology teams, and audio-recordings of the BOOST pACP conversations.DiscussionThe BOOST pACP program has been developed to stimulate conversations on ACP themes between parent(s) and the adolescents, simultaneously lowering the threshold to discuss similar themes with healthcare professionals, initiating a process of normalization and integration of ACP in standard care. This combined outcome and process evaluation aims to contribute to building the necessary evidence to improve ACP in paediatric oncology.Trial registrationThe study is registered at ISRCTN, ISRCTN33228289 . Registration date: January 22, 2021.

Dataset Information

Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.

Publications

Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets