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

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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 mm Hg vs 111.9±11.0 mm Hg, p=0.02) post surgery.

          Conclusion

          Distant reiki had no significant effect on pain following an elective C-section.

          Clinical Trial Registration Number

          ISRCTN79265996.

          Article summary

          Article focus
          • This is the first randomised, double-blinded trial conducted on distant reiki.

          • The focus in on distant reiki's effects on pain after Caesarean section.

          • Special attention was paid to the methods of proper randomisation, patient allocation concealment and blinding.

          Key messages
          • Our trial suggests that distant reiki had no benefit in reducing patients' postpartum pain over usual care for elective Caesarean section.

          Strengths and limitations of this study
          • We engaged a highly experienced reiki master to administer distant reiki removing the placebo effect which was present in all other pain trials. In addition, we maintained a high adherence to protocol, successful blinding of the research team, successful randomisation and patient allocation concealment, and diligent data collection with extremely few data points missed. We had good credibility with research participants, as all but 10 women refused to participate. We evaluated other aspects of healing after elective Caesarean section, beyond patients' perceived pain levels, by including the previously developed and published Milestone Questionnaire.

          • A potential limitation was the magnitude of pain on which we were attempting to show an impact. Just as acetaminophen is not suitable as pain medication after Caesarean section, distant reiki may also not be suitable for this magnitude of pain. In addition, since some patients were discharged early, our complete dataset is limited to 48 h, with gaps in data for 16 patients (20%) accounted for by carrying the last pain score forward. To ensure that this method did not distort the results, we also evaluated AUC for pain on day 1 and day 2 individually and found no differences between groups for both these time periods.

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          Most cited references 32

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          Pharmacogenetics of morphine poisoning in a breastfed neonate of a codeine-prescribed mother.

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            Clinical significance of reported changes in pain severity.

            To determine the amount of change in pain severity, as measured by a visual analog scale, that constitutes a minimum clinically significant difference. Patients 18 years of age or older who presented with acute pain resulting from trauma were enrolled in this prospective, descriptive study. The setting was an urban county hospital emergency department with a Level 1 trauma center. In the course of a brief interview, patients were asked to indicate their current pain severity with a single mark through a standard 100-mm visual analog scale. At intervals of 20 minutes for the next 2 hours, patients were asked to repeat this measurement and, in addition, to contrast their present pain severity with that at the time of the previous measurement. They were to indicate whether they had "much less," "a little less," "about the same," "a little more," or "much more" pain. All contrasts were made without reference to prior visual analog scale measurements. A maximum of six measurements of pain change were recorded per patient. Measurements ended when the patient left the ED or when the patient reported a pain score of zero. The minimum clinically significant change in visual analog scale pain score was defined as the mean difference between current and preceding visual analog scale scores when the subject noted a little less or a little more pain. Forty-eight subjects were enrolled, and 248 pain contrasts were recorded. Of these contrasts, 41 were rated as a little less and 39 as a little more pain. The mean difference between current and preceding visual analog scale scores in these 80 contrasts was 13 mm (95% confidence interval, 10 to 17 mm). The minimum clinically significant change in patient pain severity measured with a 100-mm visual analog scale was 13 mm. Studies of pain experience that report less than a 13-mm change in pain severity, although statistically significant, may have no clinical importance.
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              Pharmacokinetics of codeine and its metabolite morphine in ultra-rapid metabolizers due to CYP2D6 duplication.

              Codeine is an analgesic drug acting on mu-opiate receptors predominantly via its metabolite morphine, which is formed almost exclusively by the genetically polymorphic enzyme cytochrome P450 2D6 (CYP2D6). Whereas it is known that individuals lacking CYP2D6 activity (poor metabolizers, PM) suffer from poor analgesia from codeine, ultra-fast metabolizers (UM) due to the CYP2D6 gene duplication may experience exaggerated and even potentially dangerous opioidergic effects and no systematical study has been performed so far on this question. A single dose of 30 mg codeine was administered to 12 UM of CYP2D6 substrates carrying a CYP2D6 gene duplication, 11 extensive metabolizers (EM) and three PM. Genotyping was performed using polymerase chain reaction-restriction fragment length polymorphism methods and a single-base primer extension method for characterization of the gene-duplication alleles. Pharmacokinetics was measured over 24 h after drug intake and codeine and its metabolites in plasma and urine were analyzed by liquid chromatography with tandem mass spectrometry. Significant differences between the EM and UM groups were detected in areas under the plasma concentration versus time curves (AUCs) of morphine with a median (range) AUC of 11 (5-17) microg h l(-1) in EMs and 16 (10-24) microg h l(-1) in UM (P=0.02). In urine collected over 12 h, the metabolic ratios of the codeine+codeine-6-glucuronide divided by the sum of morphine+its glucuronides metabolites were 11 (6-17) in EMs and 9 (6-16) in UM (P=0.05). Ten of the 11 CYP2D6 UMs felt sedation (91%) compared to six (50%) of the 12 EMs (P=0.03). CYP2D6 genotypes predicting ultrarapid metabolism resulted in about 50% higher plasma concentrations of morphine and its glucuronides compared with the EM. No severe adverse effects were seen in the UMs in our study most likely because we used for safety reasons a low dose of only 30 mg. It might be good if physicians would know about the CYP2D6 duplication genotype of their patients before administering codeine.
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                Author and article information

                Journal
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2011
                26 February 2011
                26 February 2011
                : 1
                : 1
                Affiliations
                [1 ]Department of Pharmaceutical Sciences, University of Toronto, Toronto, Ontario, Canada
                [2 ]Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada
                [3 ]Department of Obstetrics and Gynecology, St Michael's Hospital, Toronto, Ontario, Canada
                [4 ]Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
                [5 ]Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands
                [6 ]Department of Medicine, University of Western Ontario, London, Ontario, Canada
                Author notes
                Correspondence to Dr Gideon Koren; gideon.koren@ 123456sickkids.ca
                Article
                bmjopen-2010-000021
                10.1136/bmjopen-2010-000021
                3191394
                22021729
                © 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                Product
                Categories
                Reproductive Medicine, Obstetrics and Gynaecology
                Research
                1506
                1729
                1737
                1685
                1723

                Medicine

                pain management, pain, reiki, cam, surgery, c-section, obstetrics and gynaecology, complementary medicine

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