Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial

Abstract Background Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder-fire moxibustion is commonly used in patients with neck pain, but its efficacy has rarely been systematically demonstrated. We designed a randomized trial of thunder-fire moxibustion on cervical spondylotic radiculopathy (CSR) to investigate whether it is more effective than ibuprofen sustained-release capsules. Methods One hundred patients will be recruited and randomly divided into thunder-fire moxibustion and ibuprofen groups. The intervention consists of ten treatments and will last for 2 weeks. The Yasuhisa Tanaka 20 Score Scale is used as the primary outcome measure. It contains a combination of the self-conscious symptom in patients, objective clinical evaluation from doctors, and social evaluation (the ability to work and live). The objective and comprehensive evaluation of CSR patients before and after treatment is particularly needed. The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures. The assessment will take place at the baseline and the first and second weekends of treatment. If an adverse event (AEs) occurs, it will be reported. Discussion The aim of this trial is to determine whether thunder-fire moxibustion is more effective than ibuprofen in the treatment of patients with CSR. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR1800018820. Registered on 11 October 2018.

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Homeopathic Arnica for Prevention of Pain and Bruising: Randomized Placebo-Controlled Trial in Hand Surgery

Journal of the Royal Society of Medicine ◽

10.1177/014107680309600203 ◽

2003 ◽

Vol 96 (2) ◽

pp. 60-65 ◽

Cited By ~ 35

Author(s):

C Stevinson ◽

V S Devaraj ◽

A Fountain-Barber ◽

S Hawkins ◽

E Ernst

Keyword(s):

Outcome Measures ◽

Primary Outcome ◽

Elective Surgery ◽

Short Form ◽

Controlled Trial ◽

Hand Surgery ◽

Secondary Outcome ◽

Mcgill Pain Questionnaire ◽

Double Blind ◽

Analgesic Medication

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain ( P=0.79) and bruising ( P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.

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Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

International Urogynecology Journal ◽

10.1007/s00192-021-04739-5 ◽

2021 ◽

Author(s):

Kari Bø ◽

Lene Anette H. Haakstad ◽

Gøran Paulsen ◽

Anne Mette Rustaden

Keyword(s):

Randomized Controlled Trial ◽

Urinary Incontinence ◽

Strength Training ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Sum Score ◽

New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽

10.1136/bmjopen-2021-050582 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050582

Author(s):

Annette Mollerup ◽

Sofus Christian Larsen ◽

Anita Selmer Bennetzen ◽

Marius Henriksen ◽

Mette Kildevaeld Simonsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Hospital Admission ◽

Usual Care ◽

Pulmonary Disease ◽

Controlled Trial ◽

Self Care ◽

Secondary Outcome ◽

Link Type ◽

Randomised Controlled ◽

At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

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Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India

BMJ Open ◽

10.1136/bmjopen-2016-014851 ◽

2017 ◽

Vol 7 (8) ◽

pp. e014851 ◽

Cited By ~ 14

Author(s):

Dilip Jha ◽

Priti Gupta ◽

Vamadevan S Ajay ◽

Devraj Jindal ◽

Pablo Perel ◽

...

Keyword(s):

Public Health ◽

Cost Effectiveness ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

London School ◽

Clinical Trial Registry ◽

Link Type ◽

Adherence To Medication ◽

Cluster Randomised ◽

Registration Number

IntroductionRising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysismWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and disseminationThe study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.Trial registrationmWellcare trial is registered with Clinicaltrial.gov (Registration numberNCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

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Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

10.21203/rs.2.14018/v2 ◽

2020 ◽

Author(s):

Shanshan Li ◽

Qing Zhang ◽

Xuan Yin ◽

Hongyu Yue ◽

Wei Zhang ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Postoperative Pain ◽

Endoscopic Surgery ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

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Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph19020735 ◽

2022 ◽

Vol 19 (2) ◽

pp. 735

Author(s):

Yong-Soon Yoon ◽

Myoung-Hwan Ko ◽

Il-Young Cho ◽

Cheol-Su Kim ◽

Johny Bajgai ◽

...

Keyword(s):

Physical Therapy ◽

Short Form ◽

Therapy Group ◽

Controlled Trial ◽

Low Frequency ◽

Control Group ◽

Mcgill Pain Questionnaire ◽

Low Frequency Stimulation ◽

Significant Difference ◽

Frequency Stimulation

Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG: n = 20) and physical therapy group (PTG: n = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck (p = 0.0425), shoulder (p = 0.0425), and back (p = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG (p = 0.0098), and PLSG (p = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.

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Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke

Neurology ◽

10.1212/wnl.0000000000011440 ◽

2021 ◽

pp. 10.1212/WNL.0000000000011440

Author(s):

Jong-Won Chung ◽

Won Hyuk Chang ◽

Oh Young Bang ◽

Gyeong Joon Moon ◽

Suk Jae Kim ◽

...

Keyword(s):

Stem Cells ◽

Mesenchymal Stem Cells ◽

Controlled Trial ◽

Outcome Evaluation ◽

Autologous Serum ◽

Secondary Outcome ◽

Control Group ◽

Link Type ◽

Significant Difference ◽

Major Stroke

ObjectiveTo test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.MethodsIn this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.ResultsA total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range, 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range, 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious, treatment-related adverse events.ConclusionsIntravenous application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.Classification of evidenceThis study provides Class III evidence that autologous mesenchymal stem cells do not improve 90-day outcomes in patients with chronic stroke.Trial registrationclinicaltrials.gov Identifier: NCT01716481.

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Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032799 ◽

2019 ◽

Vol 9 (10) ◽

pp. e032799 ◽

Cited By ~ 1

Author(s):

Titus Beyuo ◽

Emma Lawrence ◽

Elizabeth S Langen ◽

Samuel A Oppong

Keyword(s):

Randomised Controlled Trial ◽

Health Outcomes ◽

Magnesium Sulfate ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

University Of Michigan ◽

Clinical Trial Registry ◽

Randomised Controlled ◽

Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

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Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

RMD Open ◽

10.1136/rmdopen-2019-001040 ◽

2019 ◽

Vol 5 (2) ◽

pp. e001040 ◽

Cited By ~ 6

Author(s):

Vibeke Strand ◽

Eduardo Mysler ◽

Robert J Moots ◽

Gene V Wallenstein ◽

Ryan DeMasi ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Patient Reported Outcomes ◽

Short Form ◽

Controlled Trial ◽

Inadequate Response ◽

Link Type ◽

Combination Treatments ◽

Sf 36 ◽

Patient Reported ◽

Phase Iiib

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

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860 Impact of Orally Administered Tramadol Combined with Self-selected Music on Adult Outpatients with Burns Undergoing Dressing Change: A Randomized Controlled Trial

Journal of Burn Care & Research ◽

10.1093/jbcr/iraa024.426 ◽

2020 ◽

Vol 41 (Supplement_1) ◽

pp. S267-S268

Author(s):

Xiu-Hang Zhang ◽

Jia-Ao Yu ◽

Xin-Xin Chen

Keyword(s):

Wound Healing ◽

Primary Outcome ◽

Short Form ◽

Controlled Trial ◽

Healing Process ◽

Total Body Surface Area ◽

Control Group ◽

Mcgill Pain Questionnaire ◽

Wound Healing Process ◽

Dressing Change

Abstract Introduction Burn injuries have significant physiological and psychological consequences. Dressing changes have been considered the most painful among all non-surgical procedures. Anxiety, which is closely associated with pain, is a part of the burn and wound-healing process and can cause delays in wound healing and recovery procedures. In addition, anxiety may have a devastating mental and physical influence on patients.What’s more,patients whose symptoms were not adequately alleviated are likely to suffer more in their subsequent dressing changes. Pharmacological treatment is the primary approach for relieving pain and anxiety related to burns. In comparison with traditional analgesics, tramadol is a more manageable drug under clinical conditions. However, due to the variability of the intensity of pain and anxiety in patients, the two symptoms remain under-treated. Recently, much attention has been paid to pain management approaches that combine pharmacological treatments with non-pharmacological therapies. In this regard, this study was designed to analyze the effect of tramadol and its combination with self-selected music on burn patient. Methods To investigate the effects of music and/or tramadol on pain and anxiety in burn outpatients undergoing dressing changes. Patients (N = 180) with burns on up to 10%-30% of the total body surface area (TBSA). The patients were selected using a convenience sampling method and randomly allocated to 4 equal-sized groups as follows: 1) tramadol group (TG), patients received 100 mg of tramadol orally 20 min before the dressing change; 2) music group (MG), patients listened to self-selected music during the dressing change; 3) music-plus-tramadol group (MTG), patients received tramadol and listened to self-selected music; and 4) control group (CG), patients received a routine dressing change only. All patients underwent the interventions once per day for 2 days. McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes). Results The results showed that MTG had better outcomes with respect to pain and anxiety management during dressing changes. Conclusions In comparison with music or tramadol alone, the integration of music and tramadol offers a secure and favorable treatment choice to relieve pain and anxiety, ultimately improving the satisfaction levels of burn outpatients during dressing changes. Applicability of Research to Practice The findings showed that the combined approach was more effective in reducing pain and anxiety among the outpatients, as the findings outline the potential use of this technique in the management of dressing changes in burn outpatients.

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