Music to improve sleep quality in adults with depression related insomnia (MUSTAFI): Study protocol for a randomized controlled trial

Abstract Background Insomnia is a common sleep disorder for adults with depression with major impact on the quality of life. Previous trials suggest that music listening may be helpful in the treatment of sleep disturbances in healthy populations including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented. Objective To examine the efficacy of music listening on sleep quality, symptoms of depression and quality of life in adults with depression related insomnia. Method A single center randomized controlled trial (RCT) in a two arm parallel group design is conducted and reported according to the Consort guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish guidelines in an outpatient unit in psychiatry. The experimental group listen to music minimum 30 minutes at bedtime in four weeks. Discussion This study will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression related insomnia. This study will provide novel knowledge concerning music medicine as an evidence based treatment of depression in psychiatry. Trial Registration: Clinicaltrials.gov. ID NCT03676491, registered on 19th of September 2018. Keywords: Music, insomnia, depression, sleep

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Music to improve sleep quality in adults with depression related insomnia (MUSTAFI): Study protocol for a randomized controlled trial

10.21203/rs.2.10219/v2 ◽

2019 ◽

Author(s):

Helle Nystrup Lund ◽

Inge Nygaard Pedersen ◽

Søren Paaske Johnsen ◽

Agnieszka Maria Heymann-Szlachcinska ◽

Maryla Tuszewska ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Controlled Trial ◽

Pharmacological Intervention ◽

Music Listening ◽

Randomized Controlled ◽

Treatment Of Depression ◽

Experimental Group

Abstract Abstract Background Insomnia is a common sleep disorder for adults with depression with major impact on the quality of life. Previous trials suggest that music listening may be helpful in the treatment of sleep disturbances in healthy populations including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented. Objective To examine the efficacy of music listening on sleep quality, symptoms of depression and quality of life in adults with depression related insomnia. Method A single center randomized controlled trial (RCT) in a two arm parallel group design is conducted and reported according to the Consort guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish guidelines in an outpatient unit in psychiatry. The experimental group listen to music minimum 30 minutes at bedtime in four weeks. Discussion This study will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression related insomnia. This study will provide novel knowledge concerning music medicine as an evidence based treatment of depression in psychiatry. Trial Registration: Clinicaltrials.gov. ID NCT03676491, registered on 19th of September 2018. Keywords: Music, insomnia, depression, sleep

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Music to improve sleep quality in adults with depression related insomnia (MUSTAFI): Study protocol for a randomized controlled trial

10.21203/rs.2.10219/v4 ◽

2020 ◽

Author(s):

Helle Nystrup Lund ◽

Inge Nygaard Pedersen ◽

Søren Paaske Johnsen ◽

Agnieszka Maria Heymann-Szlachcinska ◽

Maryla Tuszewska ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Controlled Trial ◽

Pharmacological Intervention ◽

Music Listening ◽

Randomized Controlled ◽

Treatment Of Depression ◽

Experimental Group

Abstract Background Insomnia is a common sleep disorder for adults with depression with major impact on the quality of life. Previous trials suggest that music listening may be helpful in the treatment of sleep disturbances in healthy populations including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented. Objective To examine the efficacy of music listening on sleep quality, symptoms of depression and quality of life in adults with depression related insomnia. Method A single center randomized controlled trial (RCT) in a two arm parallel group design is conducted and reported according to the Consort guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish guidelines in an outpatient unit in psychiatry. The experimental group listen to music minimum 30 minutes at bedtime in four weeks. Discussion This study will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression related insomnia. This study will provide novel knowledge concerning music medicine as an evidence based treatment of depression in psychiatry. Trial Registration: Clinicaltrials.gov. ID NCT03676491, registered on 19th of September 2018. Keywords: Music, insomnia, depression, sleep

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Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

Neurorehabilitation ◽

10.3233/nre-203207 ◽

2020 ◽

Vol 47 (4) ◽

pp. 451-462

Author(s):

Júlia Caetano Martins ◽

Sylvie Nadeau ◽

Larissa Tavares Aguiar ◽

Aline Alvim Scianni ◽

Luci Fuscaldi Teixeira-Salmela ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Post Intervention ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

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Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7974816 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Mastour Saeed Alshahrani ◽

Jaya Shanker Tedla ◽

Ravi Shankar Reddy ◽

Faisal Asiri

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Disability ◽

Sf 36 ◽

Neck Disability ◽

Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

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Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v4 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03225-y ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

C. Amezcua-Prieto ◽

M. Naveiro-Fuentes ◽

N. Arco-Jiménez ◽

R. Olmedo-Requena ◽

R. Barrios-Rodríguez ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Third Trimester ◽

Randomized Controlled ◽

In Pregnancy

Abstract Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

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821 A Low FODMAP Diet Improves Quality of Life, Reduces Activity Impairment, and Improves Sleep Quality in Patients With Irritable Bowel Syndrome and Diarrhea: Results From a U.S. Randomized, Controlled Trial

Gastroenterology ◽

10.1016/s0016-5085(16)30665-5 ◽

2016 ◽

Vol 150 (4) ◽

pp. S172 ◽

Cited By ~ 3

Author(s):

Shanti L. Eswaran ◽

William D. Chey ◽

Kenya Jackson ◽

Sivaram G. Pillai ◽

Samuel W. Chey ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Sleep Quality ◽

Controlled Trial ◽

Activity Impairment ◽

Randomized Controlled ◽

Irritable Bowel ◽

Fodmap Diet

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Effects of two types of exercise training on psychological well-being, sleep, quality of life and physical fitness in patients with high-grade glioma (WHO III and IV): study protocol for a randomized controlled trial

Cancer Communications ◽

10.1186/s40880-019-0390-8 ◽

2019 ◽

Vol 39 (1) ◽

pp. 46

Author(s):

Dominik Cordier ◽

Markus Gerber ◽

Serge Brand

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Exercise Training ◽

Sleep Quality ◽

Controlled Trial ◽

High Grade Glioma ◽

Well Being ◽

High Grade ◽

Randomized Controlled

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Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

10.21203/rs.3.rs-16509/v3 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

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