scholarly journals Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

The Effect of Lavender Oil on Sleep Quality and Vital Signs in Palliative Care: A Randomized Clinical Trial

2020 ◽  
Vol 27 (5) ◽  
pp. 328-335
Author(s):  
Dilek Yıldırım ◽  
Vildan Kocatepe ◽  
Gülbeyaz Can ◽  
Ebru Sulu ◽  
Handan Akış ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Sleep Quality ◽  
Randomized Clinical Trial ◽  
Vital Signs ◽  
Control Group ◽  
Lavender Oil ◽  
The Awakening ◽  
Falling Asleep ◽  
Experimental Group

Background: This study was conducted to determine the effect of lavender oil on sleep quality and vital signs in palliative care patients. Methods: We examined 68 patients in a palliative care unit. Vital signs of all the patients were assessed, and also their sleep quality was evaluated using the Richards-Campbell Sleep Questionnaire. Lavender was applied to patients in the experimental group. During the intervention, vital signs of the patients were monitored at 4-h intervals throughout the night, and sleep quality was evaluated during the morning. The same evaluation processes were performed for the control group. Results:It was observed in the evaluation that lavender application did not affect the vital signs of the patients but it ensured a deeper sleep on the 2nd day after the intervention, facilitated their falling asleep and sleeping again when they were awakened and enhanced sleep quality (p < 0.05). Also, this application decreased the awakening frequency on the 1st and 2nd days and enhanced overall sleep quality (p < 0.05) after the intervention. Conclusions: Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.

scholarly journals Reichian elongation effect in anxiety and quality of life in nursing students: a randomized clinical trial

2020 ◽  
Vol 9 (10) ◽  
Author(s):  
Verônica de Medeiros Alves ◽  
Valéria Elias Araújo Bichara ◽  
Vanessa Christinne Nazário Tenório ◽  
Larissa de Morais Teixeira ◽  
Clarice Isabel Rosa dos Santos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Nursing Students ◽  
Randomized Clinical Trial ◽  
State Anxiety ◽  
The State ◽  
World Health ◽  
Control Group ◽  
Experimental Group

This study aims to evaluate of Reichian Elongation effect in anxiety and quality of life in nursing students. This is a prospective randomized clinical trial (Registration: RBR-2y6qcg). 143 nursing students were interviewed. The General Identification, the State-Trait Anxiety Inventory (STAI), The World Health Organization Quality of Life (WHOQOL-BREF) and MINI (Mini International Neuropsychiatric Interview) questionnaires were used. 33 received the intervention and 37 belonged to the control group. The evaluation of the elongation effect was conducted by 1, 3 and 5 months. Before intervention, experimental group presented higher trait (p= 0.005) and state anxiety mean (p= 0.049), compared to control group. There was a decrease in the state anxiety mean with 1 (p= 0.028), 3 (p= 0.031) and 5 months (p= 0.010) in experimental group. Physical (p= 0.002), psychological (p= 0.010) and social relations domain (p= 0.026) showed an increase in quality of life. Reichian Elongation contributes in reducing the symptoms of anxiety and improving the students’ quality of life.

scholarly journals Stress of nursing students in clinical simulation: a randomized clinical trial

2018 ◽  
Vol 71 (3) ◽  
pp. 967-974 ◽  
Author(s):  
Radamés Boostel ◽  
Jorge Vinícius Cestari Felix ◽  
Carina Bortolato-Major ◽  
Edivane Pedrolo ◽  
Stela Adami Vayego ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nursing Students ◽  
Randomized Clinical Trial ◽  
Interpersonal Relationships ◽  
Control Group ◽  
High Fidelity ◽  
Clinical Simulation ◽  
Skill Laboratory ◽  
Before And After ◽  
Experimental Group

ABSTRACT Objective: To evaluate and compare the perception of stressors by nursing students before and after a high-fidelity clinical simulation or conventional laboratory practice class. Method: This is a randomized clinical trial conducted with 52 nursing students. Both groups had theoretical classes about cardiothoracic physical examination, followed by practice class in skill laboratory. In addition, the experimental group took part in a high-fidelity simulation scenario. Stressors were evaluated before and after class, with the application of KEZKAK questionnaire. Results: The experimental group was significantly more worried about six factors related to lack of competence and to interpersonal relationships (p < 0.05), while the control group was significantly more worried about being in contact with suffering (p = 0.0315). Conclusion: The simulation affects students’ perception of stressors and promotes their self-evaluation and critical thinking regarding the responsibility that comes with their learning.

scholarly journals Effectiveness of a Mobile Device–Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Yuanhui Luo ◽  
Wei Xia ◽  
Ankie Tan Cheung ◽  
Laurie Long Kwan Ho ◽  
Jingping Zhang ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Training Program ◽  
Mobile Device ◽  
Well Being ◽  
Control Group ◽  
Children With Cancer ◽  
Resilience Training ◽  
Experimental Group

BACKGROUND Caring for children with cancer can be a stressful experience for parents and may have negative effects on their physical and psychological well-being. Although evidence has shown that resilience is associated with positive psychological well-being, few interventions have been specifically designed to enhance the resilience of parents of children with cancer. OBJECTIVE The aim of this study is to examine the effectiveness of a mobile device–based resilience training program in reducing depressive symptoms and enhancing resilience and quality of life (QoL) in parents of children with cancer. METHODS Parents of children diagnosed with cancer were recruited from the pediatric oncology wards of 3 tertiary hospitals in China. The participants were randomly assigned to either the experimental group (52/103, 50.5%) to undergo an 8-week mobile device–based resilience training program or to the control group (51/103, 49.5%) to receive an 8-week program of placebo information. The study outcomes included resilience, depressive symptoms, and QoL, as measured by the Connor–Davidson Resilience Scale, the Self-Rating Depression Scale, and the Short Form of the 6-Dimension Health Survey, respectively. All data were collected at baseline and at 2 and 6 months of follow-up. The data analysis followed the intention-to-treat principle. A generalized estimating equation was used to examine the effects of the intervention. RESULTS The participants were mostly female (72/103, 69.9%), and their mean age was 33.6 (SD 5.2) years. The participants in the experimental group showed significantly higher levels of resilience (mean 67.96, SD 15.8 vs mean 58.27, SD 19.0; <i>P</i><.001) and lower levels of depressive symptoms (mean 40.17, SD 9.9 vs mean 46.04, SD 10.9; <i>P</i><.001) than those in the control group at 6 months of follow-up. The intervention showed statistically significant effects in improving resilience (<i>β</i>=6.082; <i>P</i>=.01) and decreasing depressive symptoms (<i>β</i>=−2.772; <i>P</i>=.04) relative to the control group. The QoL score in the experimental group was higher than that in the control group at 6 months of follow-up (mean 0.79, SD 0.2 vs mean 0.76, SD 0.3; <i>P</i>=.07); however, no statistically significant intervention effect was detected (<i>β</i>=.020; <i>P</i>=.38). CONCLUSIONS The mobile device–based resilience training program effectively enhanced resilience and alleviated depressive symptoms in parents of children with cancer. It is highly recommended that health care professionals incorporate this resilience training program when providing psychological care to parents of children with cancer. CLINICALTRIAL Clinical.Trials.gov NCT04038242; http://clinicaltrials.gov/ct2/show/NCT04038242

scholarly journals Effectiveness of a Mobile Device–Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial

10.2196/27639 ◽  
2021 ◽  
Vol 23 (11) ◽  
pp. e27639
Author(s):  
Yuanhui Luo ◽  
Wei Xia ◽  
Ankie Tan Cheung ◽  
Laurie Long Kwan Ho ◽  
Jingping Zhang ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Training Program ◽  
Mobile Device ◽  
Well Being ◽  
Control Group ◽  
Children With Cancer ◽  
Resilience Training ◽  
Experimental Group

Background Caring for children with cancer can be a stressful experience for parents and may have negative effects on their physical and psychological well-being. Although evidence has shown that resilience is associated with positive psychological well-being, few interventions have been specifically designed to enhance the resilience of parents of children with cancer. Objective The aim of this study is to examine the effectiveness of a mobile device–based resilience training program in reducing depressive symptoms and enhancing resilience and quality of life (QoL) in parents of children with cancer. Methods Parents of children diagnosed with cancer were recruited from the pediatric oncology wards of 3 tertiary hospitals in China. The participants were randomly assigned to either the experimental group (52/103, 50.5%) to undergo an 8-week mobile device–based resilience training program or to the control group (51/103, 49.5%) to receive an 8-week program of placebo information. The study outcomes included resilience, depressive symptoms, and QoL, as measured by the Connor–Davidson Resilience Scale, the Self-Rating Depression Scale, and the Short Form of the 6-Dimension Health Survey, respectively. All data were collected at baseline and at 2 and 6 months of follow-up. The data analysis followed the intention-to-treat principle. A generalized estimating equation was used to examine the effects of the intervention. Results The participants were mostly female (72/103, 69.9%), and their mean age was 33.6 (SD 5.2) years. The participants in the experimental group showed significantly higher levels of resilience (mean 67.96, SD 15.8 vs mean 58.27, SD 19.0; P<.001) and lower levels of depressive symptoms (mean 40.17, SD 9.9 vs mean 46.04, SD 10.9; P<.001) than those in the control group at 6 months of follow-up. The intervention showed statistically significant effects in improving resilience (β=6.082; P=.01) and decreasing depressive symptoms (β=−2.772; P=.04) relative to the control group. The QoL score in the experimental group was higher than that in the control group at 6 months of follow-up (mean 0.79, SD 0.2 vs mean 0.76, SD 0.3; P=.07); however, no statistically significant intervention effect was detected (β=.020; P=.38). Conclusions The mobile device–based resilience training program effectively enhanced resilience and alleviated depressive symptoms in parents of children with cancer. It is highly recommended that health care professionals incorporate this resilience training program when providing psychological care to parents of children with cancer. Trial Registration Clinical.Trials.gov NCT04038242; http://clinicaltrials.gov/ct2/show/NCT04038242

scholarly journals The Effectiveness of Mindfulness Training on Quality of Perceptual Marital Relationship and Psychological Well-being of Women with Addicted Wife

2018 ◽  
Vol 10 (1.SP) ◽  
pp. 34
Author(s):  
Masoumeh GHARIBBOLUK ◽  
Soghra HOSSEINZADEH
Keyword(s):  
Marital Relationship ◽  
Well Being ◽  
Mindfulness Training ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Positive Thinking ◽  
Psychological Well Being ◽  
Quasi Experimental ◽  
Experimental Group

Objective: The aim of the research was to investigate the effect of Mindfulness Training on Quality of Perceptual Marital Relationship and Psychological Well-being of Women with Addicted Wife.Methods: The research method was quasi-experimental with pretest- posttest and 3 months follow up, with a control group. Among the population of Women with Addicted Wife, twenty Women with Addicted Wife (10 persons in experimental group, 10 persons in control group) were selected by purposeful sampling method and were assigned in experimental and control groups. The experimental group received 8 session (2 hours for each) of positive thinking training. For data collection, Fletcher Perceived Quality of Marital Relationship Scale and Ryff Psychological Well-Being Questionnaire were used.Results: Multivariate analysis of covariance (MANCOVA) was used for analyzing the data. The results showed the Mindfulness Training was effective on the quality of marital relationship and psychological well-being among Women with Addicted Wife. Also, the training was effective in a 3 months follow up.Conclusion: Therefore, Mindfulness Training skills can be used in prevention actions.

Abstract 452: Effect of Exercise Training on Sleep Quality and Quality of Life in Post Myocardial Infarction Patients

2016 ◽  
Vol 119 (suppl_1) ◽  
Author(s):  
Jayati Vohra ◽  
Kushal Madan ◽  
Manish Sharma ◽  
J.P.S Sawhney
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Exercise Training ◽  
Sleep Quality ◽  
Physical Functioning ◽  
Exercise Program ◽  
Exercise Group ◽  
Control Group ◽  
Experimental Group

Objectives: To study the effect of four weeks of aerobic exercise training, on sleep quality and quality of life parameters like anxiety, depression and physical functioning in Post Myocardial Infarction (MI) patients. Methods: ST elevated MI patients (n=21, <65years age) were voluntarily divided into 2 groups, control group (n=11) and exercising group (n=10). The patients in experimental group followed an exercise program of 3 sessions per week for 4 weeks. The subjective quality of life, anxiety and depression levels were assessed by the SF 36 questionnaire and Hospital Anxiety & Depression Scale (HAD scale) and the sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI). Poor sleep quality and short sleep duration was defined as PSQI > 5 and total sleep time <6hrs. respectively. After 4 weeks of the program the questionnaires were repeated for all 21 patients. Wilcoxon rank order test and Student T test were used. P<0.05 was considered statistically significant Results: Intergroup analysis showed statically significant reduction in anxiety score (9vs0.5) and depression score (3vs0) in exercise group as compared to control group respectively. As compared to control group, exercise group also showed statistically significant improvement in the quality of life parameter score [physical functioning (750vs1000), role functioning physical (0vs400) & emotional (0vs300), energy level (215vs400), emotional well-being (400vs500), social functioning (120vs200), general health (230vs462.5) & health changes (50vs100)]. Intra group analysis also showed significant changes only in exercise group. After 4 weeks of exercise training, PSQI score improved in the experimental group from 9.5±4.11 to 1.13±0.35 (p=0.00029) indicating better sleep quality and duration. While it remained comparable to the baseline values in the control group i.e. from 9.9±4.70 to 10.33±3.87 (p value= 0.514). Conclusion: Four weeks of exercise program improves the quality & duration of sleep and quality of life in MI patients after 2 weeks of index event.

scholarly journals Evaluation of the telephone intervention in the promotion of diabetes self-care: a randomized clinical trial

2016 ◽  
Vol 24 (0) ◽  
Author(s):  
Bárbara Sgarbi Morgan Fernandes ◽  
Ilka Afonso Reis ◽  
Heloisa de Carvalho Torres
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Self Care ◽  
The Self ◽  
Control Group ◽  
Telephone Intervention ◽  
Belo Horizonte ◽  
Clinical Trials Registry ◽  
Experimental Group

ABSTRACT Objective: to evaluate the effectiveness of the telephone intervention for promoting self-care related to physical activity and following a diet plan in users with diabetes, compared to conventional monitoring of users over a six-month period. Method: this was a randomized clinical trial, which included 210 users with diabetes, linked to eight Primary Health Units of Belo Horizonte, Minas Gerais. The experimental group (104 members) received six telephone interventions over the six-month monitoring; the control group (106 members) received conventional monitoring. To evaluate the self-care practices related to physical activity and following a healthy eating plan, in both groups, the self-care questionnaire was applied before the intervention and at three and six months after its start. Results: the mean effect of self-care scores in the experimental group was 1.03 to 1.78 higher than the control group, with progressive and significant improvement (p<0.001). Conclusion: the results indicate that the telephone intervention had a beneficial effect on diabetes self-care. The primary identifier of the clinical trials registry was: RBR-8wx7qb.

scholarly journals Methodological Characteristics of Clinical Trials: Impact of Mandatory Trial Registration

2019 ◽  
Vol 22 ◽  
pp. 131-141
Author(s):  
Ashish Kumar Kakkar ◽  
Biswa Mohan Padhy ◽  
Sudhir Chandra Sarangi ◽  
Yogendra Kumar Gupta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Statistical Methods ◽  
Quality Characteristics ◽  
Allocation Concealment ◽  
Trial Registration ◽  
Control Group ◽  
Study Protocols ◽  
The Impact

Purpose: Numerous studies across multiple specialties have evaluated the impact of trial registration on quality of study reports and found significant improvements over several domains. However, the impact of mandatory trial registration on the quality of clinical trial protocols remains hitherto unexplored. Methods: We carried out a retrospective cohort study of clinical trial applications submitted to drug regulatory authority of India for initial review with the objective of comparing methodological characteristics of their protocols. Since trial registration was made mandatory in the country in June 2009, we selected two study periods as between January 2007 to May 2009 (Period I) and July 2009 to December 2011 (Period II). Seventy-five protocols were randomly selected using a computer-generated list for each study period, making a total of 150 protocols. Data on twelve key methodological characteristics were collected including clearly defined primary outcomes, randomization, blinding, use of control group, statistical methods, handling of withdrawals amongst others. Results: More than 3/4th of the trial applications in the two study periods were for new chemical entities and nearly 90% were pharmaceutical industry sponsored studies. Comparing the period before and after implementation of mandatory trial registration, description of clearly defined trial outcomes improved from nearly 42% to 80% (p<0.001), sample size justifications increased from 38% to 70% (p<0.001) and use of allocation concealment improved from 24% to 49% (p=0.001). Marked improvement was also noted for blinding, description of statistical methods and handling of withdrawals and dropouts. Remaining characteristics did not change significantly between the two study periods. The mean cumulative scores for the study protocols improved significantly from 7± 0.296 in the first period to 8.93± 0.346 (p<0.001) in the second period. Conclusions: Our study found a significant improvement in the methodological quality characteristics of the protocols particularly in elements related to minimization of bias and statistical methods, which could be attributed to mandatory trial registration. Overall, the significant improvement was limited to global clinical trials, and room for improvement was noted for two quality characteristics – proportion of randomized studies and trials adequately describing the generation of allocation sequence.

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