Dataset Information

The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial.

ABSTRACT:

Introduction

Approximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer healing energy through light touch and positive healing intention. Although 1.2 million Americans use reiki to reduce pain or depression, there is a lack of strong evidence supporting its effectiveness. A recent systematic review showed existing studies to be of poor methodological quality, with the common limitation of lack of blinding. To overcome this issue, the authors used distant reiki to assess its effectiveness in reducing pain following an elective C-section.

Methods

In this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1-3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs.

Results

AUC for pain was not significantly different in the distant reiki and control groups (mean ± SD; 212.1 ± 104.7 vs 223.1 ± 117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3 ± 8.1 bpm vs 79.8 ± 7.9 bpm, p=0.003) and blood pressure (106.4 ± 9.7 mmHg vs 111.9 ± 11.0 mmHg, p=0.02) post surgery.

Conclusion

Distant reiki had no significant effect on pain following an elective C-section. Clinical Trial Registration Number ISRCTN79265996.

SUBMITTER: Vandervaart S

PROVIDER: S-EPMC3191394 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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Publications

The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial.

Vandervaart Sondra S Berger Howard H Tam Carolyn C Goh Y Ingrid YI Gijsen Violette M G J VM de Wildt Saskia N SN Taddio Anna A Koren Gideon G

BMJ open 20110226 1

<h4>Introduction</h4>Approximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer he ...[more]

PMID: 22021729

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Project description:Nausea and vomiting are common complications in patients undergoing caesarean delivery under regional anaesthesia. When experienced after surgery, they may delay recovery, reduce patient satisfaction and affect the bonding between mother and baby. Various pharmacological and non-pharmacological approaches for prophylaxis and treatment of postoperative nausea and vomiting (PONV) have been employed with different degree of efficacy. In this pilot randomised controlled trial, we aimed to determine the possible preventative effects of chewing gum on the rate of PONV in expectant mothers undergoing neuraxial anaesthesia for elective lower segment caesarean section. All participants underwent spinal anaesthesia with administration of 10-11.5 mg of intrathecal heavy Bupivicaine 0.5% according to anaesthetists' preference, Morphine 100 μg and Fentanyl 25 μg. Postoperative analgesia regimen was also standardised. Two hundred ninety-six patients were randomised to an intervention arm to receive chewing gum in addition to standard therapy and to a non-intervention arm to receive standard therapy. After exclusions, 258 patients were followed up 24 h postoperatively. Standard therapy is defined as Ondansetron 4 mg IV intra-operatively. The primary outcomes were the incidences of nausea and vomiting in the first 24 h postoperatively. Secondary outcomes were the number of episodes of nausea or vomiting in the recovery room and on the ward 24 h postoperatively, use of anti-emetics postoperatively, severity of nausea and patient satisfaction with the intervention. Our study revealed no significant differences in rates of postoperative nausea and vomiting between the intervention and standard therapy groups (41.4% v 36.9% p = 0.461). There were no significant differences in secondary outcomes between groups. Chewing gum does not reduce the incidence of PONV after elective LSCS under spinal anaesthesia. Our trial was registered with clinicaltrials.org (NCT04191694).

Project description:BackgroundThe addition of opioids to local anesthetics contributes to the quality of spinal anesthesia and postoperative analgesia.ObjectiveIn our prospective, randomized, double-blind, controlled study, our aim was to compare the effect of low-dose sufentanil plus levobupivacaine or a fentanyl plus levobupivacaine mixture on anesthesia quality, block characteristics, newborn and mother well-being, surgeon satisfaction, and duration of postoperative analgesia.MethodsNinety-three patients were randomized into 3 groups (n = 31). Patients in Group C received 0.5% levobupivacaine (2.2 ± 0.2 mL), Group S received 2.5 µg sufentanil plus 0.5% levobupivacaine (2.2 ± 0.2 mL), and Group F received 10 µg fentanyl plus 0.5% levobupivacaine (2.2 ± 0.2 mL) intrathecally completed to a volume of 3 mL with the addition of saline in all groups. Patients' demographics, sensory and motor block characteristics, hemodynamics, Apgar scores, umbilical blood gas values, maternal side effects, surgeon satisfaction score, time to first analgesia requirement, and additional analgesic use within 24 hours were recorded.ResultsIn Group S and Group F, target levels of sensory and motor block were achieved more rapidly (P < 0.001). The hemodynamic values were lower (P < 0.05), and the duration of sensory blockade and the time of first analgesic requirement were longer (P < 0.001) in Group S. Additional analgesic requirement during first 24-hour period was lowest in Group S, and highest in Group C (P < 0.001). Apgar scores and umbilical blood gas samples were similar between groups. Postoperative pruritus was more frequent in Group S (P < 0.001) and surgeon satisfaction score was significantly lower in Group C (P = 0.003).ConclusionsWe suggest that the addition of sufentanil and fentanyl to intrathecal levobupivacaine during caesarean section surgery is more effective than the administration of levobupivacaine alone. The addition of sufentanil to levobupivacaine allowed rapid onset time for sensory and motor block levels. It also extended the duration of postoperative analgesia and led to a decrease in total analgesic requirement. ClinicalTrials.gov identifier: NCT01858090.

Project description:Caesarean section is associated with moderate-to-severe postoperative pain, which can influence postoperative recovery and patient satisfaction as well as breastfeeding success and mother-child bonding. The aim of this systematic review was to update the available literature and develop recommendations for optimal pain management after elective caesarean section under neuraxial anaesthesia. A systematic review utilising procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials published in the English language between 1 May 2014 and 22 October 2020 evaluating the effects of analgesic, anaesthetic and surgical interventions were retrieved from MEDLINE, Embase and Cochrane databases. Studies evaluating pain management for emergency or unplanned operative deliveries or caesarean section performed under general anaesthesia were excluded. A total of 145 studies met the inclusion criteria. For patients undergoing elective caesarean section performed under neuraxial anaesthesia, recommendations include intrathecal morphine 50-100 µg or diamorphine 300 µg administered pre-operatively; paracetamol; non-steroidal anti-inflammatory drugs; and intravenous dexamethasone administered after delivery. If intrathecal opioid was not administered, single-injection local anaesthetic wound infiltration; continuous wound local anaesthetic infusion; and/or fascial plane blocks such as transversus abdominis plane or quadratus lumborum blocks are recommended. The postoperative regimen should include regular paracetamol and non-steroidal anti-inflammatory drugs with opioids used for rescue. The surgical technique should include a Joel-Cohen incision; non-closure of the peritoneum; and abdominal binders. Transcutaneous electrical nerve stimulation could be used as analgesic adjunct. Some of the interventions, although effective, carry risks, and consequentially were omitted from the recommendations. Some interventions were not recommended due to insufficient, inconsistent or lack of evidence. Of note, these recommendations may not be applicable to unplanned deliveries or caesarean section performed under general anaesthesia.

Project description:ObjectiveTo determine the effectiveness of closed incision negative pressure wound therapy (NPWT) compared with standard dressings in preventing surgical site infection (SSI) in obese women undergoing caesarean section.DesignMulticentre, pragmatic, randomised, controlled, parallel group, superiority trial.SettingFour Australian tertiary hospitals between October 2015 and November 2019.ParticipantsEligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section.Intervention2035 consenting women were randomised before the caesarean procedure to closed incision NPWT (n=1017) or standard dressing (n=1018). Allocation was concealed until skin closure.Main outcome measuresThe primary outcome was cumulative incidence of SSI. Secondary outcomes included depth of SSI (superficial, deep, or organ/body space), rates of wound complications (dehiscence, haematoma, seroma, bleeding, bruising), length of stay in hospital, and rates of dressing related adverse events. Women and clinicians were not masked, but the outcome assessors and statistician were blinded to treatment allocation. The pre-specified primary intention to treat analysis was based on a conservative assumption of no SSI for a minority of women (n=28) with missing outcome data. Post hoc sensitivity analyses included best case analysis and complete case analysis.ResultsIn the primary intention to treat analysis, SSI occurred in 75 (7.4%) women treated with closed incision NPWT and in 99 (9.7%) women with a standard dressing (risk ratio 0.76, 95% confidence interval 0.57 to 1.01; P=0.06). Post hoc sensitivity analyses to explore the effect of missing data found the same direction of effect (closed incision NPWT reducing SSI), with statistical significance. Blistering occurred in 40/996 (4.0%) women who received closed incision NPWT and in 23/983 (2.3%) who received the standard dressing (risk ratio 1.72, 1.04 to 2.85; P=0.03).ConclusionProphylactic closed incision NPWT for obese women after caesarean section resulted in a 24% reduction in the risk of SSI (3% reduction in absolute risk) compared with standard dressings. This difference was close to statistical significance, but it likely underestimates the effectiveness of closed incision NPWT in this population. The results of the conservative primary analysis, multivariable adjusted model, and post hoc sensitivity analysis need to be considered alongside the growing body of evidence of the benefit of closed incision NPWT and given the number of obese women undergoing caesarean section globally. The decision to use closed incision NPWT must also be weighed against the increases in skin blistering and economic considerations and should be based on shared decision making with patients.Trial registrationANZCTR identifier 12615000286549.

Project description:ObjectiveTo evaluate the cost-effectiveness of double-layer compared with single-layer uterine closure after a first caesarean section (CS) from a societal and healthcare perspective.DesignEconomic evaluation alongside a multicentre, double-blind, randomised controlled trial.Setting32 hospitals in the Netherlands, 2016-2018.Participants2292 women ≥18 years undergoing a first CS were randomly assigned (1:1). Exclusion criteria were: inability for counselling, previous uterine surgery, known menstrual disorder, placenta increta or percreta, pregnant with three or more fetuses. 1144 women were assigned to single-layer and 1148 to double-layer closure. We included 1620 women with a menstrual cycle in the main analysis.InterventionsSingle-layer unlocked uterine closure and double-layer unlocked uterine closure with the second layer imbricating the first.Main outcome measuresSpotting days, quality-adjusted life-years (QALYs), and societal costs at 9 months of follow-up. Missing data were imputed using multiple imputation.ResultsNo significant differences were found between single-layer versus double-layer closure in mean spotting days (1.44 and 1.39 days; mean difference (md) -0.056, 95% CI -0.374 to 0.263), QALYs (0.663 and 0.658; md -0.005, 95% CI -0.015 to 0.005), total healthcare costs (€744 and €727; md €-17, 95% CI -273 to 143), and total societal costs (€5689 and €5927; md €238, 95% CI -624 to 1108). The probability of the intervention being cost-effective at willingness-to-pay of €0, €10 000 and €20 000/QALY gained was 0.30, 0.27 and 0.25, respectively, (societal perspective), and 0.55, 0.41 and 0.32, respectively, (healthcare perspective).ConclusionDouble-layer uterine closure is not cost-effective compared with single-layer uterine closure from both perspectives. If this is confirmed by our long-term reproductive follow-up, we suggest to adjust uterine closure technique guidelines.Trial registration numberNTR5480/NL5380.

Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

Dataset Information

The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial.

Introduction

Methods

Results

Conclusion

Publications

The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial.

Similar Datasets

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