Effects of a physical self-care support program for patients with fibromyalgia: A randomized controlled trial

2021 ◽  
pp. 1-10
Author(s):  
Suélem B. de Lorena ◽  
Angela L.B.P. Duarte ◽  
Markus Bredemeier ◽  
Vanessa M. Fernandes ◽  
Eduardo A.S. Pimentel ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Fibromyalgia Impact Questionnaire ◽  
Self Care ◽  
Support Program ◽  
Control Group ◽  
Study Objective ◽  
Study Results ◽  
Significant Difference ◽  
Stretching Exercises ◽  
Care Support

BACKGROUND: The effects of stretching exercises in fibromyalgia (FM) deserves further study. OBJECTIVE: To evaluate the effectiveness of a Physical Self-Care Support Program (PSCSP), with emphasis on stretching exercises, in the treatment of FM. METHODS: Forty-five women with FM were randomized to the PSCSP (n= 23) or to a control group (n= 22). The PSCSP consisted of weekly 90-minute learning sessions over 10 weeks, providing instructions on wellness, postural techniques, and active stretching exercises to be done at home. The control group was monitored through 3 medical appointments over 10 weeks and included in a waiting list. The primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), the Visual Analogue Scale (VAS) for pain, and the Sit and Reach Test (SRT) at the end of the study. RESULTS: Nineteen and 21 patients completed the trial in PSCSP and control groups, respectively. After 10 weeks, the PSCSP group showed significantly better FIQ (difference between adjusted means, -13.64, 95% CI, -21.78 to -5.49, P= 0.002) and SRT scores (7.24 cm, 3.12 to 11.37, P= 0.001) than the CONTROL group, but no significant difference in pain VAS (-1.41, -3.04 to 0.22, P= 0.088). Analysis using multiple imputation (MI) and delta-adjusted MI for missing outcomes rendered similar results. CONCLUSIONS: A PSCSP emphasizing stretching exercises significantly improved FIQ and SRT scores, and may be a helpful therapy for FM.

scholarly journals Electronic Self-Report Assessment for Cancer and Self-Care Support: Results of a Multicenter Randomized Trial

2014 ◽  
Vol 32 (3) ◽  
pp. 199-205 ◽  
Author(s):  
Donna L. Berry ◽  
Fangxin Hong ◽  
Barbara Halpenny ◽  
Ann H. Partridge ◽  
Jesse R. Fann ◽  
...  
Keyword(s):  
Intervention Group ◽  
Self Care ◽  
Symptom Distress ◽  
Self Report ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Web Based ◽  
Significant Difference ◽  
Distress Scale ◽  
Care Support

Purpose The purpose of this trial was to evaluate the effect of a Web-based, self-report assessment and educational intervention on symptom distress during cancer therapy. Patients and Methods A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life (SxQOL) screening at four time points (control) versus screening, targeted education, communication coaching, and the opportunity to track/graph SxQOL over time (intervention). A summary of the participant-reported data was delivered to clinicians at each time point in both groups. All participants used the assessment before a new therapeutic regimen, at 3 to 6 weeks and 6 to 8 weeks later, completing the final assessment at the end of therapy. Change in Symptom Distress Scale–15 (SDS-15) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables. Results We detected a significant difference between study groups in mean SDS-15 score change from baseline to end of study: 1.27 (standard deviation [SD], 6.7) in the control group (higher distress) versus −0.04 (SD, 5.8) in the intervention group (lower distress). SDS-15 score was reduced by an estimated 1.21 (95% CI, 0.23 to 2.20; P = .02) in the intervention group. Baseline SDS-15 score (P < .001) and clinical service (P = .01) were predictive. Multivariable analyses suggested an interaction between age and study group (P = .06); in subset analysis, the benefit of intervention was strongest in those age > 50 years (P = .002). Conclusion Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment. Participants age > 50 years, in particular, may have benefited from the intervention.

scholarly journals Soft Tissue Response to Titanium Abutments with Different Surface Treatment: Preliminary Histologic Report of a Randomized Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Luigi Canullo ◽  
Jan Friedrich Dehner ◽  
David Penarrocha ◽  
Vittorio Checchi ◽  
Annalisa Mazzoni ◽  
...  
Keyword(s):  
Soft Tissues ◽  
Controlled Trial ◽  
Tissue Response ◽  
Polymorphonuclear Neutrophil ◽  
Control Group ◽  
Neutrophil Granulocytes ◽  
Study Results ◽  
Significant Difference ◽  
Soft Tissue Response ◽  
Cleaning Methods

The aim of this preliminary prospective RCT was to histologically evaluate peri-implant soft tissues around titanium abutments treated using different cleaning methods. Sixteen patients were randomized into three groups: laboratory customized abutments underwent Plasma of Argon treatment (Plasma Group), laboratory customized abutments underwent cleaning by steam (Steam Group), and abutments were used as they came from industry (Control Group). Seven days after the second surgery, soft tissues around abutments were harvested. Samples were histologically analyzed. Soft tissues surrounding Plasma Group abutments predominantly showed diffuse chronic infiltrate, almost no acute infiltrate, with presence of few polymorphonuclear neutrophil granulocytes, and a diffuse presence of collagenization bands. Similarly, in Steam Group, the histological analysis showed a high variability of inflammatory expression factors. Tissues harvested from Control Group showed presence of few neutrophil granulocytes, moderate presence of lymphocytes, and diffuse collagenization bands in some sections, while they showed absence of acute infiltrate in 40% of sections. However, no statistical difference was found among the tested groups for each parameter (p>0.05). Within the limit of the present study, results showed no statistically significant difference concerning inflammation and healing tendency between test and control groups.

scholarly journals Effects of Guided Reflection on Diabetes Self-Care: A Randomized Controlled Trial

2018 ◽  
Vol 45 (1) ◽  
pp. 66-79 ◽  
Author(s):  
Jennifer A. Fearon-Lynch ◽  
Kristen A. Sethares ◽  
Marilyn E. Asselin ◽  
Kristine Batty ◽  
Caitlin M. Stover
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Diabetes Research ◽  
Diabetes Knowledge ◽  
Convenience Sample ◽  
Randomized Controlled ◽  
Significant Difference

The purpose of this study was to evaluate the effects of guided reflection on self-care behaviors, confidence scores, and diabetes knowledge among adults with diabetes. A randomized controlled trial with a pre/posttest design was used to generate data from a convenience sample of 62 adults with diabetes recruited from a single site. After viewing a 30-minute video on how to manage diabetes, participants were randomized to a control group (CG) (usual care) or an intervention group (IG). The IG further engaged in a reflection educational session. For 8 weeks, the IG isolated diabetes-related events weekly, critically analyzed them using Gibbs’s reflective questions, and recorded their analysis in a journal. They also shared their perspective relative to using the journal in an audiotaped interview. Main measures included baseline and 8-week clinical outcomes (self-care maintenance, monitoring, management, and confidence scores and diabetes knowledge scores) and intervention acceptability. Compared to the CG, the IG had no statistically significant difference in self-care measures over time, although scores trended in the anticipated direction. Importantly, both groups had statistically significant improvement in self-care scores. Furthermore, there was statistically significant improvement in diabetes knowledge among IG participants. Informatively, IG critically analyzed 147 diabetes-related events concentrating on blood glucose, diet, exercise, monitoring, medication, sleep pattern, and health care visits. Participants found the guided reflection activity highly acceptable. Combined educational and reflection interventions are effective approaches for improving self-care outcomes and diabetes knowledge among adults with diabetes. Research concentrating on purposeful patient reflection is warranted in a larger sample paying careful attention to study limitations.

scholarly journals Does Preoperative Balance Training Reduce Pain and Improve Joint Function in Patients After Total Knee Arthroplasty? A Randomized Controlled Trial

2020 ◽  
Author(s):  
Wang Chen ◽  
Jian-Ning Sun ◽  
Zheng-Hao Hu ◽  
Xiang-Yang Chen ◽  
Shuo Feng
Keyword(s):  
Controlled Trial ◽  
Balance Training ◽  
Training Group ◽  
Womac Score ◽  
Control Group ◽  
Joint Function ◽  
Koos Score ◽  
Study Results ◽  
Significant Difference ◽  
And Control

Abstract Background Part of patients undergoing TKA did not achieve the expected physiological function results. The purpose of this study was to investigate whether preoperative balance training can reduce pain and improve joint function after TKA.Methods 100 patients with knee osteoarthritis (OA) prepared for TKA, according to the inclusion and exclusion criteria, were randomly divided into balance training group (50 patients) and control group (50 patients). The main evaluation outcomes of the study included early functional milestones, ROM, WOMAC score, keen society score (KSS), KOOS score, and complications at 1 month (baseline) and 1 day before surgery, 6 weeks (main endpoint) and 52 weeks (1 year) after surgery.Results 4 patients lost to follow-up at 1 month before surgery, 96 received planned surgery and 86 underwent a complete postoperative evaluation. After TKA, many indicators of the two groups, including WOMAC score, KSS, KOOS score, were significantly improved compared with before surgery. At 52 weeks after TKA, no statistically significant difference between the balance training group and control group in attain early functional milestones, ROM, WOMAC score, KSS, KOOS score, and complications; however, at 6 weeks after surgery, balance training group had better early benefits in stopping all narcotics (P = 0.045), relieving pain (P = 0.037), improving function (P = 0.017) and quality of life (QOL) (P = 0.028).Conclusions Although there were no difference between preoperative balance training group and control group at the 52 weeks after surgery, however, preoperative balance training can relieve pain and improve function in the early stage (6 weeks), but adequately statistically powered trials are needed to confrm the accuracy of the study resultsTrial Registration ChiCTR2000032789.

scholarly journals The sophrology as adjuvant therapy may improve the functionality of patients with fibromyalgia. A pilot randomized controlled trial

2020 ◽  
pp. 1-5 ◽  
Author(s):  
Franciele Santos de Oliveira ◽  
Hugo Jario de Almeida Silva ◽  
Jaine Maria de Pontes Oliveira ◽  
José Felipe Costa da Silva ◽  
Valéria Lidyanne Silva Gomes ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Fibromyalgia Impact Questionnaire ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Assessment Instruments ◽  
Timed Up And Go ◽  
Resistance Training Program ◽  
Significant Difference ◽  
Relaxation Exercises

Introduction: Sophrology is the science of the serene spirit applied to human consciousness. Body relaxation exercises are not yet a consensus in the treatment of fibromyalgia. Objective: To investigate the effectiveness of a relaxation exercise program based on sophrology in patients with fibromyalgia. Method: This is a pilot study, controlled, randomized and with blinded evaluator and eighteen patients with medical diagnosis of fibromyalgia were randomized into two groups: the intervention group (IG) who participated in sophrology sessions (n= 8) and control group (CG) who participated of a resistance training program (n= 10). Both groups underwent treatments 2 times per week for 12 weeks and reevaluations every 4 weeks. The assessment instruments used were the visual analogic scale of pain (VAS), the satisfaction with the treatment by the Likert scale, the 6-minute walk test (6MWT), the Timed Up and Go test (TUG) and the Fibromyalgia Impact Questionnaire (FIQ). Results: We did not find statistical differences in any of the variables between the groups. The intragroup evaluation, there was a significant difference in CG for TC6 (p= 0.01) and TUG (p= 0.04). In IG there was a statistically significant difference (p = 0.02) for the FIQ. Conclusion: Thus, the improvement in 6MWT and TUG in the CG and the improvement in the FIQ in the IG group showed promising results, although studies with larger sample is needed for more accurate results.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

2018 ◽  
Vol 7 ◽  
Author(s):  
Azita Kamjoo
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Singleton Pregnancy ◽  
Group Data ◽  
Significant Difference ◽  
Labor Length ◽  
Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

The effect of foot reflexology on chemotherapy-induced nausea and vomiting in digestive or lung cancer patients: a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Audrey Murat-Ringot ◽  
Pierre Jean Souquet ◽  
Fabien Subtil ◽  
Florent Boutitie ◽  
Marie Preau ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Digestive Cancer ◽  
Complementary Medicines ◽  
Antiemetic Drugs ◽  
Platinum Based Chemotherapy ◽  
Significant Difference ◽  
Delayed Nausea

BACKGROUND Cancer is a chronic disease with an incident worldwide had been 24.5 million and 9.6 million deaths in 2017. Lung and colorectal cancer are the most common cancer for both sexes and according to national and international recommendations platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting may persist. Moreover, cancer patient are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology decreases significantly the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. OBJECTIVE The primary objective of the present study was to assess the benefits of foot reflexology as a complement to conventional treatments on severity of acute chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives assessed were the frequency and severity of delayed chemotherapy-induced nausea and vomiting, quality of life, anxiety, and self-esteem. METHODS The present study was conducted between April 2018 and April 2020 in French University Hospital. This is an open-label randomized controlled trial. Participants are randomized into two groups: 40 to interventional group (conventional care with foot reflexology) and 40 to control group (conventional care without foot reflexology). Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. RESULTS The severity of acute nausea and vomiting was assessed with a visual analogue scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for control group (20.6%, P = 0.01). Across all cycle, the foot reflexology group showed a trend towards less frequent delayed nausea (P=0.28), a significantly less frequent consumption of antiemetic drugs (P=0.04), and no significant difference for vomiting (P=0.99); there was a trend towards a perception of stronger severity for delayed nausea in the control group (P=0.39). According to quality of life and anxiety, there was no significant difference between the interventional group and the control group (P=0.32 and P=0.53 respectively). CONCLUSIONS In conclusion, the present study results indicated that foot reflexology decreased significantly the severity of acute nausea and consumption of antiemetic drugs in lung and digestive cancer patients. No side effects from foot reflexology have been noted. In order to better respond to a desire of patients for non-pharmacological treatments and CAMs to be used in hospitals to improve their care, the results of this study showed that foot reflexology seems to be a promising complement to conventional antiemetic drugs. To assess the performance of this intervention in routine practice, a larger study with several health care centers would be relevant with a cluster RCT. CLINICALTRIAL The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018) INTERNATIONAL REGISTERED REPORT RR2-10.2196/17232

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