Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

2020 ◽  
pp. bmjspcare-2020-002618
Author(s):  
Azam Dehghani ◽  
Ali Hajibagheri ◽  
Ismail Azizi-Fini ◽  
Fatemeh Atoof ◽  
Noushin Mousavi
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Surgery ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Early Mobilisation ◽  
Repeated Measures Analysis ◽  
The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

scholarly journals The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

2015 ◽  
Vol 4 (1) ◽  
pp. 26-32
Author(s):  
Sara Azima ◽  
Hajar Rajaei Bakhshayesh ◽  
Keramatollah Abbasnia ◽  
Maasumeh Kaviani ◽  
Mehrab Sayadi
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea  were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

scholarly journals The effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes: A clinical trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 282 ◽  
Author(s):  
Mehrafza Gharachourlo ◽  
Zohreh Mahmoodi ◽  
Mahnaz Akbari Kamrani ◽  
Maryam Tehranizadeh ◽  
Kourosh Kabir
Keyword(s):  
Clinical Trial ◽  
Health Literacy ◽  
Gestational Diabetes ◽  
Intervention Group ◽  
Trial Registration ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Unhealthy Lifestyle ◽  
Pregnancy Care ◽  
The Mean

Background: Gestational diabetes is a common pregnancy disorder that affects the mother’s and neonate’s health. The present study was conducted to investigate the effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes. The present randomized controlled clinical trial was conducted in 2017 using a parallel design. The subjects included 84 eligible women presenting to Alborz and Kamali Hospitals, Karaj, Iran. Methods: Convenience sampling was first used to select the subjects. They were then assigned to an intervention or control group based on randomized blocks of four. Both groups attended counselling sessions. The mothers in the intervention group attended six sessions of counselling with a health literacy approach in addition to counselling on routine pregnancy care. The control group attended counselling sessions on safe pregnancy care and received a training package containing all the subjects discussed in the intervention group. The Lifestyle Questionnaire and the Iranian Health Literacy Questionnaire were completed by the mothers at the beginning and at the end of the sessions as well as three weeks after the sessions. The data obtained were analyzed in SPSS-19. Results: According to the study findings, the scores of lifestyle (P=0.8) and health literacy (P=0.423) showed no significant differences between the intervention and control groups before the intervention. Significant differences were, however, observed in the mean scores of lifestyle and health literacy between the two groups immediately and three weeks after the intervention. Comparing the means showed a higher increase in the mean scores in the intervention group (P<0.001). Conclusions: Providing counselling services by midwives can significantly help modify mothers’ unhealthy lifestyle choices and increase their health literacy; therefore, reducing maternal and neonatal consequences, especially in high-risk pregnancies. Trial registration number: IRCT2017021427728N3 Trial registry: Iranian Registry of Clinical Trials Trial registration date: 5th April 2017

scholarly journals Smartphone application for celiac patients: assessing its effect on gastrointestinal symptoms in a randomized controlled clinical trial

2020 ◽  
Author(s):  
Zeinab Nikniaz ◽  
Masood Shirmohammadi ◽  
Elham Masserat ◽  
Zahra Akbari Namvar
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Gastrointestinal Symptoms ◽  
Smartphone Application ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Trial Registry ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Abstract Background: We aimed to study the effectiveness of a “celiac” smartphone application on gastrointestinal symptoms in celiac patients. Methods: In the present randomized controlled clinical trial, 60 celiac patients were randomly assigned to receive education through a smartphone application (n=30) or conventional clinical education (n=30). We assessed the gastrointestinal symptoms using the gastrointestinal symptom rating scale (GSRS) questionnaire at baseline and three months after interventions. The GSRS total score, celiac disease GSRS (CD-GSRS) score, abdominal pain, reflux, diarrhea, constipation, and indigestion scores were calculated. Results: Out of 60 randomized patients, 58 patients completed the study. In comparison to baseline, the mean score of GSRS total score (p=0.04), CD-GSRS score (p=0.001), and indigestion subscore (p<0.001) were significantly decreased in the intervention group. In the control group, compared to baseline, the mean scores of CD-GSRS score (p=0.03) and abdominal pain subscore (p=0.04) were significantly reduced; and the mean score of reflux (p=0.01) subscore was significantly increased. The results of the between-group comparisons showed that although the mean GSRS and CD-GSRS total scores were lower in the intervention group compared with the control group, the differences were not statistically significant. In terms of GSRS subscores, there was a significant difference between the two groups only in the mean score of indigestion (P=0.01).Conclusion: According to the results, smartphone application had a significantly positive effect on indigestion symptoms compared with routine clinic education. However, more large studies with longer duration of the follow-up period are needed to assure this approach Trial registration: The protocol of the study was registered in the Iranian registry of clinical trials (IRCT code: IRCT20170117032004N2). trial registry webpage: : https://www.irct.ir/user/trial/40187/view. Trial registry date: 2019.6.26

scholarly journals Effects of Reflexology on the Pain Intensity among Patients with Depression after Receiving Electroconvulsive Therapy: A Randomized Clinical Trial

2021 ◽  
Vol 10 (3) ◽  
pp. 129-136
Author(s):  
Maryam Aliashraf Jodat ◽  
Leyla Alilu ◽  
Sohila Ahangarzadeh Rezayee ◽  
Rasool Gharaaghaji Asl
Keyword(s):  
Pain Intensity ◽  
Health Care Providers ◽  
Electroconvulsive Therapy ◽  
Muscle Pain ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Care Providers ◽  
Significant Difference ◽  
The Mean

Introduction: High prevalence of psychiatric disorders and the high effectiveness of electroconvulsive therapy (ECT) have made this treatment a useful intervention. Memory impairment, headache, and muscle pain are the most important complications after ECT. This research aimed to determine the effect of reflexology on the headache and muscle pain intensity of patients after receiving ECT. Methods: This randomized controlled trial was conducted in Razi teaching hospital of Urmia, Iran. A total of 56 patients with depression receiving ECT were randomly assigned into two equal groups of control (n=28) and intervention (n=28). In the intervention group, reflexology was performed for 20 minutes at reflex points and, in the control group, only the conventional measures were taken. Pain intensity was measured with visual analogue scale (VAS) before and 1, 6, and 24 hours after the intervention. Data were analyzed using the SPSS software version 13. Furthermore, chi-square, Mann-Whitney, Wilcoxon, and repeated-measures tests were performed. Results: The mean difference in the severity of headache and muscle pain in the intervention group was significantly reduced compared to the control group. Moreover, the results demonstrated a significant difference between the mean headache and muscle pain in the two groups after the intervention. Conclusion: The results of this study showed the positive effect of reflexology on reducing the intensity of pain in patients receiving ECT. Thus, it is recommended that nurses, health care providers, and caregivers use reflexology to reduce pain in patients with depression receiving ECT.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Negative Air Pressure on Wet Cupping in Decreasing Blood Pressures in Hypertensive Patients

2018 ◽  
Vol 7 (2) ◽  
pp. 116
Author(s):  
Budi Darmawan ◽  
Diyah Fatmasari ◽  
Rr. Sri Endang Pujiast
Keyword(s):  
Blood Pressure ◽  
Repeated Measures ◽  
Community Health Centers ◽  
Intervention Group ◽  
Air Pressure ◽  
Control Group ◽  
P Value ◽  
Decrease Blood Pressure ◽  
Blood Pressures ◽  
The Mean

Background: Wet cupping, furthermore mentioned cupping, decreases blood pressures through the level of negative air pressures added by hydrostatics filtration pressure to reinforce the power of fluids filtration in capillaries. However, an appropriate negative air pressure to decrease blood pressure remains an uncertainty.Purpose: This study aimed to analyze negative air pressure differences on cupping in decreasing blood pressures in hypertensive patients.Methods: This is a quasi-experimental design conducted in three Community Health Centers in Langsa City, Aceh, Indonesia. The samples were 36 hypertensive males with age from 45 to 55, who were randomly stratified into two groups with cupping pressures 400 mbar (n=18) as the control group; and 540 mbar (n=18) as the intervention group. The cupping session was performed to each group on T1 (alkahil) point and in the middle line of both shoulders blade points. The systolic blood pressure (SBP) and diastolic blood pressures (DBP) were measured by validated automatic sphygmomanometer. The follow-up periods were one week and two weeks. The data were then analyzed by repeated measures ANOVA.Results: Cupping pressure of 400 mbar decreased the mean of SBP and DPB with a p-value of 0.450 and 0.026, respectively after two weeks of intervention. Meanwhile, cupping pressure of 540 mbar decreased the mean of SBP and DBP with a p-value of 0.006 and 0.057, respectively. Tests of within-subjects resulted in the p-value of 0.250 (SBP) and 0.176 (DBP) after two weeks of intervention. There were no significant differences in SBP and DBP between the intervention group and the control group.Conclusion: The cupping pressure between 400 mbar and 540 mbar could reduce blood pressure; however, the cupping pressure of 540 mbar yielded greater effect in decreasing blood pressure than the 400 mbar. Negative air vacuum pressure loads on cupping to decrease blood pressure should be considered between 400 to 540 mbar, and further studies are needed.

scholarly journals The Effect of Rhythmic Breathing on the Severity of Sternotomy Pain after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hassan Babamohamadi ◽  
Masoumeh Karkeabadi ◽  
Abbasali Ebrahimian
Keyword(s):  
Clinical Trial ◽  
Pain Control ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Artery Bypass Graft ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Background. Moderate-to-severe pain is reported in up to 75% of the patients in the first 48 hours after cardiac surgery. Evidence suggests that distraction is an effective nursing intervention for controlling short-term and transient pain. Distraction can be achieved by various techniques, including progressive muscle relaxation, meditation, and rhythmic breathing (RB). The present research aimed at evaluating the impacts of RB on the severity of sternotomy pain after Coronary Artery Bypass Graft (CABG). Methods. This randomized, controlled clinical trial was conducted on 60 patients after CABG surgery at the open-heart surgery Intensive Care Unit (ICU) of Kowsar Hospital, affiliated to Semnan University of Medical Sciences in Semnan, Iran. The patients were selected through convenience sampling and randomly assigned to two groups, including (1) intervention or RB and (2) control groups. RB was performed in the intervention group every 12 hours (9 a.m. and 9 p.m.) for three consecutive days after the surgery. The control group received only routine care for pain control (opioid analgesics) with no additional interventions. The severity of pain was measured every day in both groups of patients before and after the interventions using the Visual Analog Scale (VAS). Results. The mean postintervention pain scores were significantly different from the mean preintervention scores in the intervention group ( p  < 0.05). The changes in the mean pain score in the intervention group were also significantly different from the corresponding changes in the controls ( p  < 0.05). Conclusion. Based on the results, the severity of pain after the intervention was significantly lower in the RB group compared to the control. RB was found to be an effective technique for reducing the patients’ pain and is therefore recommended as a post-CABG pain control technique. Iranian Registry of Clinical Trials: this trial is clinically registered with IRCT20120109008665N7, registered 3 September 2018.

scholarly journals The Effect of Health Literacy Counselling on Self-Care in Women after Mastectomy: a Randomized Clinical Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 39-45
Author(s):  
Masoume Rastegar ◽  
Zohreh Mahmoodi ◽  
Sara Esmaelzadeh Saeieh ◽  
Nasibeh Sharifi ◽  
Kourosh Kabir
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Health Literacy ◽  
Intervention Group ◽  
Self Care ◽  
Essential Element ◽  
World Health ◽  
Control Group ◽  
Fars Province ◽  
The Mean

Introduction: Breast cancer has a high prevalence, constituting a major cause of mortality in women around the world. Health literacy has a vital role in the self-care of chronic diseases such as cancer and is an essential element in the ability of each person to engage with health promotion. The aim of this study was to determine effect of health literacy counselling on selfcare in women after mastectomy. Methods: This study is a randomized, controlled, clinical trial carried out on 72 women with breast cancer after mastectomy in Fars province. The eligible women entered the study using convenience sampling and were then divided into an intervention and a control group through randomized blocks of four. Health literacy questionnaire and self-care questionnaire were distributed among the participants before, immediately after and three weeks following the intervention. Data analysis was performed in SPSS ver.13. Results: The results showed no significant differences between the two groups in terms of their health literacy and self-care scores before the intervention (P=0.299 and 0.059). A comparison of the mean values showed a greater increase in the mean score of health literacy and score of selfcare immediately and three weeks after the intervention in the intervention group compared to the control group. Also, the mean score of the dimensions of self-care in chemotherapy increased over time in the intervention group. Conclusion: The findings of this study confirm the higher effectiveness of counseling with a health literacy approach on overall self-care in chemotherapy and all its dimensions.

scholarly journals The Effect of the Mobile ‘Blood Pressure Management Application’ on Hypertension Self-Management Enhancement: A Randomised Controlled Trial

2019 ◽  
Author(s):  
Ali Bozorgi ◽  
Hamed Hosseini ◽  
Hassan Eftekhar ◽  
Reza Majdzadeh ◽  
Ali Yoonessi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Clinical Trial ◽  
Repeated Measures ◽  
Patient Adherence ◽  
Intervention Group ◽  
Public Hospitals ◽  
Self Management ◽  
Control Group ◽  
Management Application

Abstract Background : Self-management of blood pressure is of great significance given the increasing incidence of hypertension and associated disabilities. With the increased use of mobile health in medicine, the present study evaluated the effect of the self-management application on patient adherence to hypertension treatment. Methods : This clinical trial was performed on 120 hypertensive patients who were provided with a mobile intervention for 8 weeks and followed-up to 24 th weeks. Data on the primary outcome (adherence to treatment) and secondary outcomes (adherence to the DASH diet, regular monitoring of blood pressure, and physical activity) were collected using a questionnaire and a mobile application, respectively. The inter-group change difference over time was analyzed using repeated measures ANOVA (General Linear Model). Results : The treatment adherence score increased by an average of 5.9 (95%CI: 5.0-6.7) in the intervention group compared to the control group. Scores of adherence to the low-fat and low-salt diet plans were 1.7 (95%CI: 1.3-2.1) and 1.5 (95%CI: 1.2-1.9), respectively. Moreover, moderate physical activity increased to 100.0 minutes (95%CI: 61.7-138.3) per week in the intervention group. Conclusion: The treatment and control of blood pressure require a multifaceted approach given its complexity and multifactorial nature. Considering the widespread use of smartphones , mhealth interventions can be effective in self-management and better patient adherence to treatments. Our results showed that this application can be used as a successful tool for hypertension self-management in patients attending public hospitals in developing countries. Trial registration: This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

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