Efficacy of acupuncture and its influence on the emotional network in adult insomnia patients: protocol for a randomized controlled clinical trial

Abstract Introduction Insomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trapped in a vicious circle of bad moods and poor sleep. Resting-state functional magnetic resonance imaging (r-fMRI) studies have shown abnormalities in emotion-related brain networks in patients with ID. And it has been proven that reducing negative emotions improves sleep quality. As a traditional alternative therapy, acupuncture has been demonstrated to be effective not only in improving sleep quality but also in stabilizing emotions; however, the mode of action needs to be further explored. Therefore, a clinical trial was designed to explore the effect of acupuncture in improving sleep and mood and to intuitively investigate the regulation of the emotional network using fMRI. Methods and analysis A total of 60 participants with ID will be randomly allocated to a spirit-regulating group or a control group using non-effective acupoints acupuncture at a ratio of 1:1. All participants will receive 3 acupuncture treatment sessions per week for 4 weeks. In addition, 30 healthy individuals will be included in the healthy group. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Hyperarousal Scale (HAS), and the Fatigue Scale-14 (FS-14), r-fMRI data, sleep diary, and actigraphy. The data will be collected prior to treatment, following treatment, and during the 12-week follow-up period; a sleep diary will be kept during the entire process. Ethics and dissemination This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital). The results will be published in peer-reviewed journals or presented at academic conferences. Trial registration Chinese Clinical Trials Register ChiCTR1800015282. Protocol version: Version 1.0. Date: Dec.2020

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Efficacy of Acupuncture and Its Influence on the Emotional Network in Insomnia Disorder: Protocol for a Randomized Controlled Clinical Trial

10.21203/rs.3.rs-640684/v1 ◽

2021 ◽

Author(s):

Tongfei Jiang ◽

Jing Guo ◽

Qi Zhang ◽

Fan Zhang ◽

Fang Yuan

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Negative Emotions ◽

Depression Scale ◽

Sleep Diary ◽

Control Group ◽

Controlled Clinical Trial ◽

Poor Sleep ◽

Hamilton Depression Scale ◽

Insomnia Disorder

Abstract IntroductionInsomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trapped in a vicious circle of bad moods and poor sleep. Resting-state functional magnetic resonance imaging (r-fMRI) studies have shown abnormalities in emotion-related brain networks in patients with ID. And it has been proven that reducing negative emotions improves sleep quality. As a traditional alternative therapy, acupuncture has been demonstrated to be effective not only in improving sleep quality but also in stabilizing emotions; however, the mode of action needs to be further explored. Therefore, a clinical trial was designed to explore the effect of acupuncture in improving sleep and mood, and to intuitively investigate the regulation of the emotional network using fMRI. Methods and AnalysisA total of 60 participants with ID will be randomly allocated to a spirit-regulating group or a control group using non-effective acupoints acupuncture at a ratio of 1:1. All participants will receive 3 acupuncture treatment sessions per week for 4 weeks. In addition, 30 healthy individuals will be included in the healthy group. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Hyperarousal Scale (HAS), and the Fatigue Scale-14 (FS-14), r-fMRI data, sleep diary, and actigraphy. The data will be collected prior to treatment, following treatment, and during the 12 weeks follow-up period; a sleep diary will be kept during the entire process. Ethics and Dissemination This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital). The results will be published in peer-reviewed journals or presented at academic conferences. Trial registration: Chinese Clinical Trials Register, ChiCTR1800015282.

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Omega-3 in The Treatment of Mood and Sleep Disorders Induced by Hormone Therapy in Women with Breast Cancer: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

10.21203/rs.3.rs-1055943/v1 ◽

2021 ◽

Author(s):

Behzad Nourosi ◽

Erfan Naghsh ◽

Sahar Esmaeil zadeh ◽

Valiollah Mehrzad ◽

Ali Darakhshandeh ◽

...

Keyword(s):

Breast Cancer ◽

Sleep Quality ◽

Hormone Therapy ◽

Mood Disorders ◽

Intervention Group ◽

Depression Scale ◽

Control Group ◽

Controlled Clinical Trial ◽

Omega 3 ◽

Falling Asleep

Abstract Purpose This study was performed to investigate the effect of omega-3 on the treatment of mood and sleep disorder induced by menopausal complications due to hormone therapy in patients with breast cancer. Methods A placebo, double-blind and controlled trial was designed in oncology-hematology outpatient’s clinic of Omid Hospital, Isfahan, Iran. First, sixty patients were screened by hospital anxiety and depression scale (HADS) for any baseline mood disorders and then divided into either intervention group who had received 2 grams’ omega-3 daily for 4 weeks or identical placebo. Then, the patients were considered to assess by center for epidemiological studies-depression scale (CES-D), profile of mood states (POMS), and Pittsburgh sleep quality index (PSQI) questionnaires at the baseline and after 4-week follow-up. Results Findings showed that the mean scores of CES-D (P = 0.002), POMS (P = 0.03), and PSQI (P = 0.04) were significantly lower in the intervention group than the control group. In the intervention group, mean scores of CES-D (P <0.001), POMS (P <0.001), and PSQI (P = 0.003) were significantly lower in post-intervention than pre-intervention. Mean changes in scores of CES-D (P = 0.01), POMS (P = 0.001), and PSQI (P = 0.02) were significantly higher in the intervention group than the control group. Conclusion Our findings revealed that omega-3 supplementation have the potential to reduce mood disorders as well as to improve sleep quality in terms of subjective sleep quality, delay in falling asleep, sleep delay, and sleep disturbance in patients with breast cancer.

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Pain threshold, sleep quality and anxiety levels in individuals with temporomandibular disorders

Revista CEFAC ◽

10.1590/1982-0216201820414417 ◽

2018 ◽

Vol 20 (4) ◽

pp. 450-458

Author(s):

Carla Raquel de Melo Daher ◽

Larissa Fernandes da Cunha ◽

Ana Paula de Lima Ferreira ◽

Ana Izabela Sobral de Oliveira Souza ◽

Tiago Albuquerque Maranhão Rêgo ◽

...

Keyword(s):

Sleep Quality ◽

Temporomandibular Disorders ◽

Pain Threshold ◽

Pressure Pain Threshold ◽

Depression Scale ◽

Control Group ◽

Poor Sleep ◽

Cross Sectional ◽

Significant Difference ◽

Anxiety Levels

ABSTRACT Purpose: to evaluate the pressure pain threshold, sleep quality and anxiety levels of individuals with different types of chronic temporomandibular disorders (TMD). Methods: a controlled, observational and cross-sectional study. TMD diagnosis followed the Research Diagnostic Criteria and the volunteers were divided into three groups: A-Muscular Disorder (n = 15), B- Articular Disorder (n = 10) and C- Control Group (n = 15). Evaluation was performed using the Pittsburg Sleep Quality Index, Visual Analog Scale, Algometry and Hospital Anxiety and Depression Scale. The significance level for all tests was 5%. Results: lower threshold of pain was seen in the masticatory and cervical musculature within groups A and B. However, when TMD groups were compared to the control group, only a statistically significant difference in the pain threshold of the masticatory muscle and the trapezius muscle was found. Groups A and B presented poor sleep quality, showing a statistical difference when compared to the control group. Additionally, it was observed that patients in the groups with TMD presented anxiety, while those in the control group, did not present it. Conclusion: individuals presented with TMD show lower levels of pain threshold, sleep quality and anxiety, as compared to healthy subjects. These results do not depend on the type of disorder presented.

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Effects of HIIT and MIIT Suspension Training Programs on Sleep Quality and Fatigue in Older Adults: Randomized Controlled Clinical Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18031211 ◽

2021 ◽

Vol 18 (3) ◽

pp. 1211

Author(s):

José Daniel Jiménez-García ◽

Fidel Hita-Contreras ◽

Manuel Jesús de la Torre-Cruz ◽

Agustín Aibar-Almazán ◽

Alexander Achalandabaso-Ochoa ◽

...

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Training Programs ◽

The Elderly ◽

Moderate Intensity ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Post Intervention ◽

Randomized Controlled

Poor sleep quality lessens general health quality and is related to physical and mental problems. Moreover, fatigue is one of the foremost common complaints in medical care and plays a role in the decreasing quality of life of the older population. For these reasons, the objective of this study was to examine the effect of high- and moderate-intensity interval training programs (HIIT vs. MIIT)—both consisting of twelve weeks of TRX training—on the sleep quality and fatigue levels of the elderly. A randomized controlled clinical trial (NCT03404830) was conducted. A total of 82 subjects were randomized to either a HIIT group (n = 28) that performed a main squat activity with a suspension system, comprising four four-minute intervals between 90–95% of the maximum heart rate (HR), an MIIT group (n = 27) with an intensity of 70% of the maximum HR, and a control group (CG) (n = 27) that continued their daily lifestyle. The two exercise groups trained twice a week for 12 weeks, with each session lasting 45 min. Sleep quality was measured using the Pittsburgh sleep quality index (PSQI), and fatigue was assessed using the fatigue severity scale (FSS). Outcomes were measured before the intervention and after the intervention period. Post-intervention sleep quality measurements revealed a statistically significant interaction regarding group × time (p < 0.005) and fatigue (p = 0.002). Specifically, fatigue decreased in the HIIT group between both measurement moments (p = 0.003). In addition, differences were obtained in the post-intervention measure between the HIIT and MIIT groups (p = 0.013) and HIIT and control (p = 0.029). Our analysis indicates that a population of the elderly showed improvements in sleep quality and fatigue after performing a high-intensity intervention using suspension training (TRX), with markedly better results in the HIIT group.

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Virtual Reality Alleviates Post-Stroke Depression by Regulating FGF21

10.21203/rs.3.rs-619520/v1 ◽

2021 ◽

Author(s):

Yihui Zhang ◽

Zekun Xing ◽

Zhanxiang Xie ◽

Yuzheng Zhou ◽

Shengjie Wan ◽

...

Keyword(s):

Clinical Trial ◽

Virtual Reality ◽

Depression Scale ◽

Trial Registration ◽

Fibroblast Growth Factor 21 ◽

Control Group ◽

Hamilton Depression Scale ◽

Post Stroke ◽

Post Stroke Depression ◽

Experimental Group

Abstract Background: Post-stroke depression(PSD) lacks timely and effective treatment and virtual reality (VR) technology can create a lifelike experience and simulate users' physical presence in an immersive environment. It has been confirmed to have a positive effect on stroke and depression. Data about the efficacy VR on PSD are limited. The intensification of fibroblast growth factor 21(FGF21) can improve depression and other emotional symptoms, but there is no study on its role in PSD.Methods: We enlisted 76 PSD patients (6 lost) and divided into the experimental group and control group randomly. The patient underwent psychological rehabilitation once a week for 50 minutes each time for a total of 12 weeks. The patients in the experimental group received psychological counseling and VR rehabilitation while patients in the control group also took the same pattern but without VR rehabilitation. The Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) were evaluated before rehabilitation, in the 4th week and at the end of rehabilitation respectively in two groups for the sake of observing changes in the patients' depression. Then 8 people in each group did functional near-infrared spectroscopy (fNIRS), and blood samples were taken for detection with brain-derived neurotrophic factor (BDNF), IL-6, TNF-α and FGF21 by ELISA.Results: The result of fNIRS showed the hemodynamic activation in the prefrontal region of the experimental group was significantly increased. Both groups of FGF21 increased and compared with the control group, the experimental group has a greater upsurge and a faster increase rate.Conclusions: VR alleviates PSD. FGF21 is closely related to PSD，and it is likely to be a potential pathological mechanism of PSD. It suggests that VR is possible to improve PSD by increasing FGF21.Trial registration: We registered in Chinese Clinical Trial Registry which is the first level registration organization of WHO international clinical trial registration platform. The registration number is ChiCTR1900027987, the date of registration December 7, 2019.

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A Clinical Study of the Effect of Estradiol Valerate on Sleep Disorders, Negative Emotions, and Quality of Life in Perimenopausal Women

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/8037459 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Jianfu Zhang ◽

Shurong Shao ◽

Chaohui Ye ◽

Bengui Jiang

Keyword(s):

Quality Of Life ◽

Sleep Quality ◽

Sleep Disturbances ◽

Endometrial Thickness ◽

Negative Emotions ◽

Depression Scale ◽

Estradiol Valerate ◽

Control Group ◽

Perimenopausal Syndrome

In this prospective study, we randomly divided 100 patients with perimenopausal syndrome equally into the control group (n = 50) receiving conventional treatment and the study group (n = 50) receiving estradiol valerate. The indicators observed were endometrial thickness, uterine volume, and the levels of LH (luteinizing hormone), FSH (follicle-stimulating hormone), and E2 (estradiol) of the patients before and after treatment. The Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety/Depression Scale (HAMA/HAMD), Kupperman symptom score, and menopause-specific quality of life (MENQOL) were also applied to assess the sleep quality, negative emotions, severity of the condition, and quality of life of all patients, respectively. Our findings were that estradiol valerate is beneficial in improving serum sex hormone levels, sleep disturbances, negative mood, and quality of life in patients with perimenopausal syndrome and that its safety profile is high enough to warrant clinical promotion.

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Increase in the folate level can decrease the intensity of disorder in patients with depression who use citalopram: a randomized clinical trial

10.21203/rs.3.rs-18168/v1 ◽

2020 ◽

Author(s):

Masume Morovati ◽

Yousef Morsali ◽

Saeed Rezaee ◽

Ayoub Pezeshki ◽

Abdolreza Esmaeilzadeh ◽

...

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Depression Scale ◽

Controlled Clinical Trial ◽

Depression Symptoms ◽

High Dose ◽

World Population ◽

Hamilton Depression Scale ◽

Folate Level ◽

Long Term Treatment

Abstract Background Depression is one of the most common mental health disorders, which affiliated more than four percent of world population. Several antidepressant agents, including citalopram were developed. High dose and long-term treatment with these agents along with their side effects decrease the treatment adherence. Using supplements such as acid folic is a way to increase these drug’s efficacy. The aim of this study was to assess the effect of acid folic supplement and increase in blood folate level of the intensity of depression symptoms.Methods This was a randomized-controlled clinical trial. Twenty-four patients with major depression were randomly assigned to two groups. Both groups received citalopram as their standard treatment. The intervention group received acid folic supplement (1mg/daily). The folate levels of blood, Beck's depression inventory and Hamilton depression scale scores were measured. The measurements were conducted before intervention, and in 45 and 90 days follow ups. Data were analyzed using Mann-Whitney U and Friedman tests.Results The blood level of folate was increased for the intervention group. The Hamilton depression scale and Beck Depression Inventory Scores were reduced significantly in both groups after 90 days follow up. There were no significant differences between two groups in the reduction of depression scores. In the intervention group, the decrease of Hamilton's depression scale score was negatively correlated to the increase of blood folate level.Conclusions The increase in blood folate level may be correlate with the decrease in depression symptoms. The use of 1mg/d supplement of acid folic was not effective in the reduction of depression symptoms in patients with major depression.Registered in Iranian Registry of Clinical Trials (IRCT20180115038373N1)

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

BMC Psychology ◽

10.1186/s40359-021-00547-0 ◽

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.

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Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

Trials ◽

10.1186/s13063-021-05218-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Rico Krämer ◽

Stephan Köhler

Keyword(s):

Depressive Symptoms ◽

Depression Scale ◽

Drop Out ◽

Control Group ◽

Hamilton Depression Scale ◽

Online Interventions ◽

Phone Calls ◽

Self Help ◽

Low Threshold ◽

The Impact

Abstract Background Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the supply of low-threshold treatment. Further research is needed to evaluate the effectiveness of online interventions. This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and compares the impact of the programme’s unaccompanied version with its therapeutic accompanied version. Methods A sample of 400 subjects that have a mild to severe depressive episode (Becks Depression Inventory - II and Hamilton Depression Scale) will be used. Subjects are randomly assigned to immediate access to an unaccompanied course (no support from psychologist via weekly phone calls), immediate access to an accompanied course (support from a psychologist via weekly phone calls) or a waiting list control group (access to the intervention after 24 weeks). The intervention will last for a period of 12 weeks. Depressive symptoms as a primary parameter, as well as various secondary parameters, such as life satisfaction, therapeutic relationships, social activation, self-esteem, attitudes towards Internet interventions and drop-out rates, are recorded at four different points in time: at baseline (T1), 6 weeks after the start of the intervention (T2), 12 weeks after the start of the intervention (T3) and 3 months after completion of the treatment follow-up (T4). Conclusion This randomized and controlled, blinded study will make use of a “dismantled” approach to adequately compare the accompanied and unaccompanied versions of the intervention. Positive and meaningful results are expected that could influence the acceptance and implementation of online interventions. Trial registration German Clinical Trials Register DRKS00017191. Registered on 14 June 2019

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The control of pain due to dentin hypersensitivity in individuals with molar–incisor hypomineralisation: a protocol for a randomised controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-044653 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044653

Author(s):

Ana Paula Taboada Sobral ◽

Elaine Marcilio Santos ◽

Ana Cecilia Aranha ◽

Paulo Vinícius Soares ◽

Caroline Moraes Moriyama ◽

...

Keyword(s):

Clinical Trial ◽

Tooth Enamel ◽

Control Group ◽

Controlled Clinical Trial ◽

Dentin Hypersensitivity ◽

Molar Incisor Hypomineralisation ◽

Randomised Controlled Clinical Trial ◽

Sensitive Teeth ◽

Randomised Controlled ◽

Incisor Hypomineralisation

IntroductionDentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar–incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.Methods and analysisOne hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.Ethics and disseminationThis protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT04407702.

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