scholarly journals Effectiveness of self-applied acupressure for cervical pain of benign origin (EDIDO-CUH): a randomized controlled clinical trial

2020 ◽  
pp. 096452842096139
Author(s):  
Calvo Trujillo Susana ◽  
Toribio Martín Luisa Maria ◽  
Domenech Senra Pilar ◽  
Mingo Moreno Teresa María ◽  
Marín Solano Pilar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Health Professional ◽  
Intervention Group ◽  
Outcome Variable ◽  
Controlled Clinical Trial ◽  
Cervical Pain ◽  
Usual Practice ◽  
Utility Index

Background: Cervical pain is a problem with a high prevalence of ~13% of the population, and is more common in women (16.5%). The most affected age group is 65–74 years. Our aim was to assess the effectiveness of self-applied acupressure for decreasing benign-origin cervical pain, under the supervision of a health professional and in combination with usual treatment, as well as to examine its impact on the patient’s self-perceived health condition and their opinion of the technique. Methods: Pragmatic, multicenter, controlled clinical trial randomized by healthcare center. A total of 160 patients with benign-origin cervical pain between 18 and 65 years of age who attended primary care were included from 12 healthcare centers in the autonomous community of Madrid by consecutive sampling, and randomly assigned to a control or intervention group. The main outcome variable was pain intensity measured on a visual analogue scale (VAS) and secondary variables were self-perceived quality of life (EuroQol-5D utility index) and functional ability (neck disability index). An explanative model of generalized estimating equations was built taking into account the lack of independence among observations. The analysis was performed over 6 months. Results: In total, 150 patients completed the study. Mean age was 45 years (SD: 10.7), 86.7% were women, 86.2% were currently employed, and 57.9% did not perform any physical exercise. Average days experiencing pain was 32.9 (SD: 2.8) and 80% were undergoing previous pharmacological treatment. The quality of life utility index after 3 months was 1.6 points (95% CI: 0.54–2.71) higher in the intervention group. The pain score on the VAS was 0.16 points (95% CI: 0.80–0.48) lower in the intervention group. The health professional explained 10.4% of the reduction in pain observed on the VAS throughout the medical visits. Conclusion: Acupressure applied in addition to usual practice appeared to improve cervical pain in the long term. The effectiveness of this technique was partially explained by the health professional that trained the participants on technique application. Trial registration number:: NCT01855893

scholarly journals The Effect of Positive Thinking Training on Different Dimensions of Quality of Life of Hemodialysis Patients: A Randomized Controlled Clinical Trial

2020 ◽  
Vol 12 (3) ◽  
Author(s):  
Mahmoudreza Peyravi ◽  
Mehdi Amirkhani ◽  
Faeze Abadi ◽  
Ali Abbasijahromi ◽  
Shima Sheidaie ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Emotional Health ◽  
Intervention Group ◽  
Hemodialysis Patients ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Positive Thinking ◽  
Different Dimensions

Background: Nowadays, the quality of life of hemodialysis patients has decreased, which doubled the need for educational interventions. Objectives: The current study investigated the effect of positive thinking training on different dimensions of quality of life of hemodialysis patients. Methods: This is a controlled clinical trial study conducted on 70 hemodialysis patients in Fasa, Fars province, in 2019. The patients were selected using the simple sampling method. Then, they were divided into two groups of intervention (n = 35) and control (n = 35). After obtaining informed consent, the researchers asked the participants to complete the SF-36 Quality of Life Questionnaire. The intervention group was trained positive thinking skills in 8 workshop sessions; each lasted for 90 minutes. Data were analyzed using SPSS version 20. To analyze the data, statistical tests such as chi-square, Kolmogorov-Smirnov, independent, and t-test were used. Results: The mean and standard deviation of the patients’ quality of life in the intervention group increased from 35.95 ± 10.07 to 55.98 ± 11.71 (P < 0.001). The changes in patients’ quality of life before and after the intervention were also assessed in 8 dimensions, which showed that the quality of life of the patients did not change significantly in terms of physical function (P = 0.42) and physical pain (P = 0.62), but for other dimensions, it was significantly increased (P < 0.001). Conclusions: Positive thinking training improved the quality of life of hemodialysis patients, particularly in the dimensions of the emotional role, emotional health, energy and vitality, social performance, and general health is recommended.

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HEQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Does Synbiotic Supplementation Affect the Quality of Life in Children with Cystic Fibrosis? A Pilot Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis.Results Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34 ± 17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after probiotic and placebo supplementation (p > 0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores.Conclusion According to results, six-month supplementation with synbiotic did not have a significant effect on the HEQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion.

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

BMC Nutrition ◽  
2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF. Methods In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for 6 months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34 ± 17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p > 0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals The Effect of Resilience Training on Stress, Anxiety, Depression, and Quality of Life of Hemodialysis Patients: A Randomized Controlled Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mehdi Amirkhani ◽  
Nasrin Shokrpour ◽  
Leila Bazrafcan ◽  
Ameneh Modreki ◽  
Shima Sheidai
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Intervention Group ◽  
Hemodialysis Patients ◽  
T Test ◽  
Controlled Clinical Trial ◽  
Before And After ◽  
Resilience Training ◽  
Anxiety Depression

Background: Today, the prevalence of psychological problems such as stress, anxiety, and depression in hemodialysis patients has increased and affected their quality of life. Objectives: Given the relationship between resilience interventions and psychological problems, this study aimed to investigate the effect of resilience training on stress, anxiety, depression, and quality of life in hemodialysis patients. Methods: This was a controlled clinical trial study on 57 hemodialysis patients referred to Fasa city hemodialysis centers from October to December 2019. Patients were selected using a simple sampling method and divided into two groups of intervention (n = 29) and control (n = 28) using the block randomization method. In 12 sessions of a 90-minute workshop, the intervention group was taught resilience skills by a clinical psychologist. Before and after the intervention, stress, anxiety, depression, and quality of life were measured using the Depression anxiety stress scale (DASS) 21 and SF-36 questionnaires. Data were analyzed with Statistical Package for the Social Sciences (SPSS) software version 20 using t-test, Kolmogorov-Smirnov, and chi-Square tests. Results: According to the paired t-test, the patients’ mean score of stress, anxiety, and quality of life significantly decreased in the intervention group (P < 0.001), whereas depression score did not significantly change after the intervention (P = 0.689). The difference in the mean scores of stress, anxiety, depression, and quality of patients' life was not significant in the intervention group before the intervention and in the control group before and after the intervention (P > 0.05). Conclusions: Resilience training reduced stress and anxiety in hemodialysis patients and improved their quality of life. Thus the use of resilience intervention programs along with other methods for hemodialysis patients' care and treatment programs is recommended as a non-invasive, non-pharmacological, inexpensive, and cost-effective method without complications.

A randomized trial of the effect of peer education on the sexual quality of life in patients with myocardial infarction

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasi ◽  
Hossein Ebrahimi ◽  
Hossein Bagheri ◽  
Mohammad Hasan Basirinezhad ◽  
Seyedmohammad Mirhosseini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Health Care Professionals ◽  
Peer Education ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Sexual Quality Of Life ◽  
Significant Difference

AbstractBackgroundOne of the factors associated with readmission is inappropriate sexual activity after myocardial infarction (MI). This study aimed to assess the effect of peer education on the sexual quality of life (SQOL) in patients with MI.MethodsIn this randomized controlled clinical trial, 70 patients with MI meeting the inclusion criteria were assigned to experimental or control groups using block randomization. Peer education for the intervention group was provided on the third day after MI. Education sessions lasted from 90 to 120 minutes. Data were collected using demographic, sexual quality of life-female (SQOL-F), and sexual quality of life-male (SQOL-M) questionnaires during the fourth week after MI.ResultsThere was no significant difference between the two groups before the intervention in terms of demographic and SQOL. The mean of SQOL in the peer education group was significantly higher than the control group at the 4-week follow-up.ConclusionsAccording to the results, using peer education is recommended for the sexual health care professionals.

A randomized controlled clinical trial of a psychosocial and communication intervention carried out by GPs for patients with medically unexplained symptoms

2006 ◽  
Vol 37 (2) ◽  
pp. 283-294 ◽  
Author(s):  
JOSÉ M. AIARZAGUENA ◽  
GONZALO GRANDES ◽  
IDOIA GAMINDE ◽  
AGUSTÍN SALAZAR ◽  
ÁLVARO SÁNCHEZ ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intervention Group ◽  
Medically Unexplained Symptoms ◽  
Randomized Controlled ◽  
Communication Techniques ◽  
Utility Index ◽  
Sf 36 ◽  
Medically Unexplained ◽  
Unexplained Symptoms

Background. Somatizing patients are a challenge to general practitioners (GPs). A cluster randomized controlled trial was conducted to asses the effect of specific communication techniques delivered by GPs on somatizing patients' self-perceived health.Method. Thirty-nine GPs were assigned randomly to two parallel groups. GPs in the intervention group treated somatic patients according to specific communication techniques focused on offering a physical explanation – release of hormones – and approaching sensitive topics in the patient's experience indirectly. Control GPs used the standard Goldberg reattribution technique. A total of 156 patients, aged 18–65 years, were selected randomly from a list of 468 patients with six or more active symptoms for women and four or more for men. All patients had six programmed 30-min consultations. Health-related quality of life (assessed with the 36-item Short-Form Health Survey, SF-36) and a summary utility index were used as outcome measures. Patients were interviewed at home at baseline and at 3, 8 and 12 months after the beginning of the intervention.Results. Patients in both groups improved in all dimensions of the SF-36. The time course of the quality of life was significantly better for the intervention group in five of the eight scales of the SF-36 (bodily pain, mental health, physical functioning, vitality, and social functioning) and in the utility index (p<0·039).Conclusions. Communication techniques were found to have a clinically relevant impact on body pain. This finding, together with a trend towards better scores in the remaining scales, justifies the use of these techniques in psychosocial interventions delivered to patients with medically unexplained symptoms.

Effect Of The Combination Of Automated Peripheral Mechanical Stimulation And Physical Exercise On Aerobic Functional Capacity And Cardiac Autonomic Control: A Randomized Clinical Trial Protocol.

2021 ◽  
Author(s):  
Nicolle Aileen Zelada-Astudillo ◽  
Andrea Herrera-Santelices ◽  
Fabio Augusto Barbieri ◽  
Vinicius Christianini Moreno ◽  
Antonio Roberto Zamunér
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Physical Exercise ◽  
Mechanical Stimulation ◽  
Autonomic Control ◽  
Treatment Modalities ◽  
Controlled Clinical Trial ◽  
Cardiac Autonomic Control ◽  
Gait Parameters

Abstract ● Background: Automated peripheral mechanical stimulation (AMPS) has been proposed as a new complementary therapy with potential for improving motor and cardiovascular abnormalities in Parkinson's disease (PD). However, AMPS long-term effects and its combination with physical exercise is unknown. Thus, this study aims to compare the effects of a program of 12 weeks of physical exercise with a 12-week intervention program combining physical exercise and AMPS on the aerobic capacity, cardiac autonomic control and gait parameters in patients with PD.● Methods: A randomized, controlled clinical trial will be conducted. Volunteers will be randomly assigned to one of the two groups studied: 1) Exercise; or 2) AMPS + Exercise. Both groups will undergo an exercise program of 24 sessions, for 12 weeks, performed twice a week. Before exercise sessions, the group AMPS+Exercise will receive a session of active AMPS, while the group Exercise will receive an AMPS sham intervention. Shapiro-wilk’s and Levene’s tests will be used to check for data normality and homogeneity, respectively. In case parametric assumptions are fulfilled, per-protocol and intention-to-treat analyses will be performed using a mixed model analysis of variance to check for Group*Time interaction. Significance level will be set at 5%. ● Discussion: Several non-pharmacological treatment modalities have been proposed for PD, focusing primarily on the reduction of motor and musculoskeletal disorders. Regular exercise and motor training have been shown to be effective in improving quality of life. However, treatment options in general remain limited given the high prevalence and adverse impact of these disorders. So, developing new strategies that can potentiate the improvement of motor disabilities and also improve non-motor symptoms in PD is relevant. It is expected that the participants from both groups will improve their quality of life, gait parameters and their cardiac autonomic control, with greater improvements being observed in the group combining active AMPS and physical exercise.Trial registration: ClinicalTrials.gov, NCT04251728, registered February 05, 2020

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