The effects of earplugs and eye masks on sleep quality of patients admitted to coronary care units: A randomised clinical trial

2021 ◽  
Author(s):  
Homeira Khoddam ◽  
Seyedmahrokh A. Maddah ◽  
Sommayeh Rezvani Khorshidi ◽  
Mohammad Zaman Kamkar ◽  
Mahnaz Modanloo
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Randomised Clinical Trial ◽  
Coronary Care ◽  
Coronary Care Units

scholarly journals Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial

BMC Nursing ◽  
2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Inmaculada Valero-Cantero ◽  
Yolanda Carrión-Velasco ◽  
Cristina Casals ◽  
Francisco Javier Martínez-Valero ◽  
Francisco Javier Barón-López ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Sleep Quality ◽  
Music Therapy ◽  
Cancer Patients ◽  
Randomised Clinical Trial ◽  
Therapeutic Education ◽  
Increased Risk ◽  
Two Samples

Abstract Background Sleep disorders are commonly experienced by community caregivers for persons with cancer, with at least 72% reporting moderate to severe disorders. A consequence of this condition, which is associated with the presence of overload in the caregiver, is the increased risk of clinical depression. The aim of this study is to evaluate the effects of music on the sleep quality achieved by informal caregivers for cancer patients receiving home palliative care. In addition, we will assess the influence of specific variables that could modify these effects, analyse the correlates related to nocturnal wakefulness and consider the diurnal consequences according to the sleep characteristics identified. Methods This single-blind, multicentre, randomised clinical trial will focus on informal providers of care for cancer patients. Two samples of 40 caregivers will be recruited. The first, intervention, group will receive seven music-based sessions. The control group will be masked with seven sessions of therapeutic education (reinforcing previous sessions). Outcomes will be evaluated using the Pittsburgh Sleep Quality Index, a triaxial accelerometer, EuroQol-5D-5L, the Caregiver Strain Index, the Epworth Sleepiness Scale and the Client Satisfaction Questionnaire. The caregivers’ satisfaction with the intervention performed will also be examined. Discussion This study is expected to extend our understanding of the efficacy of music therapy in enhancing the sleep quality of caregivers for patients receiving home palliative care. To our knowledge, no reliable scientific investigations of this subject have previously been undertaken. Music is believed to benefit certain aspects of sleep, but this has yet to be proven and, according to a Cochrane review, high-quality research in this field is necessary. One of the main strengths of our study, which heightens the quality of the randomised clinical trial design, is the objective assessment of physical activity by accelerometry and the use of both objective and subjective measures of sleep in caregivers. Music therapy for the caregivers addressed in this study is complementary, readily applicable, provokes no harmful side effects and may produce significant benefits. Trial registration The IMECA study is registered at Clinical Trials.gov, ClinicalTrials.gov Identifier: NCT04491110. Registered 29 July, 2020.

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 effects of animal-assisted interactions on quality of life in children with life-threatening conditions and their parents

2021 ◽  
Vol 27 (10) ◽  
pp. 524-530
Author(s):  
Haley Walker ◽  
Mary Chapman Miller ◽  
Brittany Cowfer ◽  
Terrah Akard ◽  
Mary Jo Gilmer
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Palliative Care ◽  
Primary Caregivers ◽  
Randomised Clinical Trial ◽  
Severe Stress ◽  
Quality Of Life Research ◽  
Threatening Condition ◽  
Life Threatening

Background: Children with advanced cancer and their primary caregivers may experience severe stress and anxiety in coping with their life-threatening condition. As a way to help reduce these stressors and increase overall quality of life, research suggests that animal-assisted interactions may be beneficial when integrated into palliative care. Aims: This pilot study aims to provide evidence for the feasibility and efficacy of a randomised clinical trial using animal-assisted interactions to help improve the quality of life for children with an advanced life-threatening condition and their primary caregivers. This protocol paper outlines the basis of the research, goals, experimental design and methodology.

scholarly journals Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035768
Author(s):  
Josefa Gonzalez-Santos ◽  
Raul Soto-Camara ◽  
Paula Rodriguez-Fernández ◽  
Maria Jimenez-Barrios ◽  
Jeronimo Gonzalez-Bernal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Upper Extremity ◽  
Randomised Clinical Trial ◽  
Therapeutic Exercise ◽  
Mirror Therapy ◽  
Link Type ◽  
Home Based ◽  
Study Results ◽  
Task Oriented

IntroductionNeuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.Methods and analysisThis is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).Ethics and disseminationThis protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.Trial registration numberClinicalTrials.gov (NCT04163666).

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