The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

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Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial

Prevention Science ◽

10.1007/s11121-020-01145-z ◽

2020 ◽

Vol 21 (8) ◽

pp. 1028-1036

Author(s):

Takeo Fujiwara ◽

Aya Isumi ◽

Makiko Sampei ◽

Yusuke Miyazaki ◽

Fujiko Yamada ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Educational Video ◽

Health Checkup ◽

Infant Crying ◽

Randomized Controlled ◽

Cluster Randomized ◽

And Control

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.

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Effect of Continues Midwifery Support in Labor on the Childbirth Experience and Self-Esteem of Primipara Women: A Randomized Controlled Trial

10.21203/rs.3.rs-833826/v1 ◽

2021 ◽

Author(s):

Nasrin Soleimani ◽

Mansoureh Refaei ◽

Farideh Kazemi

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Self Esteem ◽

Control Group ◽

Randomized Controlled ◽

Childbirth Experience ◽

Cohen’S D ◽

The Mean ◽

Cohen's D

Abstract Background: The World Health Organization states that mothers during labor and delivery should be supported by people with whom they feel comfortable, because one of the non-pharmacological methods of relieving labor pain is the continued support of midwives in labor. The primary objectives of this study were to determine the effect of continuous midwifery support in labor on delivery experience and self-esteem of nulliparous women 6 weeks after delivery.Methods: This randomized controlled trial was performed in 2021 on 70 pregnant women admitted to the delivery ward who met the inclusion criteria. Participants were randomly allocated to two groups through balanced block randomization with a block size of 4. Participants completed a demographic and midwifery information questionnaire before entering the study. In the intervention group, in addition to routine labor care, the researcher was present at the mother's bedside and was present with the mother continuously throughout the labor and up to 2 hours after delivery and provided the necessary support. The control group received only routine labor and postpartum care. Six weeks after delivery, participants in both groups were contacted to complete the CEQ and Rosenberg self-esteem questionnaires. Finally, data were collected and analyzed. Significance level was considered 0.05.Results: By controlling the effect of duration of the first and second stages of labor as potential confounders, the mean (sd) of childbirth experience 6 weeks after delivery was 70.92 (7.07) in the intervention group and 59.69 (7.08) in the control group, and this difference was statistically significant (p <0.001). The amount of effect size indicates a very strong effect of the intervention on improving the childbirth experience (Cohen’s d = 1.69; 95% CI: 1.12, 2.26). Comparison of the mean of maternal self-esteem showed that this rate in the intervention group was 2 scores higher than the control group and this difference was statistically significant (p = 0.05). Cohen's d indicates the average effect of intervention on mothers' self-esteem score (Cohen's d = 0.56; 95% CI: 0.06, 1.05).Conclusions: Continuous support of the midwife in labor and up to 2 hours after delivery can lead to a better childbirth experience and increase the mother's self-esteem up to 6 weeks after delivery.Trial registration: IRCT ID: IRCT20201102049233N1, First Registration date: 2021-06-04

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Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial

Current Clinical Pharmacology ◽

10.2174/1574884714666191007154936 ◽

2020 ◽

Vol 15 (2) ◽

pp. 164-169

Author(s):

Fatemeh Abbasalizadeh ◽

Khadijeh Pouya ◽

Raana Zakeri ◽

Rana Asgari-Arbat ◽

Shamsi Abbasalizadeh ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Premature Infants ◽

Distress Syndrome ◽

Controlled Trial ◽

Intervention Group ◽

Neonatal Outcomes ◽

Control Group ◽

Randomized Controlled ◽

Neonatal Respiratory Distress ◽

And Control

Background: Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious. Objective: We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial. Method: 140 women with a multifetal pregnancy at less than 28 weeks’ gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1. Result: The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups. Conclusion: Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.

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The Effect of the Web-Based Communication between a Nurse and a Family Member on the Perceived Stress of the Family Member of Patients with Suspected or Confirmed COVID-19: A Parallel Randomized Clinical Trial

Clinical Nursing Research ◽

10.1177/10547738211017688 ◽

2021 ◽

pp. 105477382110176

Author(s):

Esmail Shariati ◽

Ali Dadgari ◽

Seyedeh Solmaz Talebi ◽

Gholam Reza Mahmoodi Shan ◽

Hossein Ebrahimi

Keyword(s):

Family Member ◽

Perceived Stress ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled ◽

The Family ◽

Before And After ◽

The Mean

The aim of this study was to identify the effect of web-based communication between a nurse and a family member of a patient with COVID-19 on his/her perceived stress. In this multicenter parallel randomized controlled trial, 67 family members of COVID-19 patients admitted to the Intensive Care Unit (ICU) were investigated. In the intervention group, web-based communication was performed for four consecutive days for 10 to 15 minutes. The Perceived Stress Scale (PSS-14) were completed in both groups before and after the intervention. Mean and standard deviation of perceived stress scores in the two groups were not significantly different ( p = 0.26) before the intervention; however, after the intervention, the mean PSS-14 in the intervention group was significantly lower than that of the control group ( p < 0.001). Due to the need to follow the physical and social distancing to protect against Coronavirus disease, the use of web-based communication recommended in future studies.

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Patients’ Acceptability of Computer-Based Information on Hypodontia: A Randomized Controlled Trial

JDR Clinical & Translational Research ◽

10.1177/2380084418773992 ◽

2018 ◽

Vol 3 (3) ◽

pp. 246-255

Author(s):

A. Ben Gassem ◽

R. Foxton ◽

D. Bister ◽

J.T. Newton

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Care Facility ◽

Control Group ◽

Randomized Controlled ◽

Education Material ◽

Computer Based ◽

The Mean ◽

Evaluation Inventory

Objectives: To compare patients’ acceptability of a hypodontia-specific interactive computer-based education material (ICB-EM) versus a British Orthodontic Society (BOS) hypodontia leaflet. Trial Design: Two-arm parallel randomized controlled trial, 1:1 allocation ratio. Methods: The study was conducted at a specialized secondary care facility in the Greater London area. Ninety-six new hypodontia patients aged 14 y and older were randomly assigned to the control group ( n = 49) receiving the BOS leaflet or the intervention group ( n = 47) receiving the ICB-EM. The main outcome measure was patients’ evaluation of the intervention measured by the treatment evaluation inventory. Results: The analyzed sample comprised 76 participants: control group ( n = 38) and intervention group ( n = 38). The mean age of the sample was 19 y (SD = 7.24) and 20.3 y (SD = 6.9) for the control and intervention group, respectively. The intervention group was significantly more satisfied with the ICB-EM than individuals who received the BOS leaflet ( t = −3.53, P = 0.001). Conclusion: Patients preferred the computer-based information. Knowledge Transfer Statement: Patients attending dental care in the 21st century are adept in the use of computerised facilities for obtaining information. The results of the study will provide valuable evidence for clinicians on the level of acceptability of the patients toward interactive computer based health education as opposed to traditional paper leaflets.

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A Randomized Controlled Trial on the Usefulness of Mobile Text Phone Messages to Improve the Quality of Care of HIV and AIDS Patients in Cameroon

The Open AIDS Journal ◽

10.2174/1874613601610010093 ◽

2016 ◽

Vol 10 (1) ◽

pp. 93-103 ◽

Cited By ~ 12

Author(s):

Dickson Shey Nsagha ◽

Innocent Lange ◽

Peter Nde Fon ◽

Jules Clement Nguedia Assob ◽

Elvis Asangbeng Tanue

Keyword(s):

Randomized Controlled Trial ◽

Health Care Services ◽

Controlled Trial ◽

Intervention Group ◽

Hiv And Aids ◽

Baseline Survey ◽

Control Group ◽

People Living With Hiv ◽

Randomized Controlled ◽

Before And After

Background:HIV and AIDS are major public health problems in the world and Africa. In Cameroon, the HIV prevalence is 5.1%. Cellphones have been found to be useful in the provision of modern health care services using short message services (SMS). This study assessed the effectiveness of SMS in improving the adherence of people living with HIV and AIDS to their treatment and care in Cameroon.Methods:This intervention study used a randomized controlled trial design. Ninety participants seeking treatment at the Nkwen Baptist Health Center were recruited between August and September 2011 using a purposive sampling method. They were randomly allocated into the intervention and control groups, each containing 45 participants. In the intervention group, each participant received four SMSs per week at equal intervals for four weeks. The patients were investigated for adherence to ARVs by evaluating the number of times treatment and medication refill appointments were missed. Data were collected using an interviewer-administered questionnaire before and after intervention and analysed on STATA.Results:The baseline survey indicated that there were 55(61.1%) females and 35(38.9%) males aged 23 - 62 years; the mean age was 38.77 ± 1.08. Most participants were teachers [12 (13.3%)], farmers [11 (12.2%)], and businessmen [24 (26.7%)]. Adherence to ARVs was 64.4% in the intervention group and 44.2% in the control group (p= 0.05). 2(4.4%) patients in the control group failed to respect their drug refill appointments while all the 45(100%) participants in the intervention group respected their drug refill appointments. 54.17% of married people and 42.9% of the participants with primary and secondary levels of education missed their treatment. Key reasons for missing treatment were late home coming (54%), forgetfulness (22.5%), and travelling out of station without medication (17.5%). Other factors responsible for non-adherence included involvement in outdoor business (60.87%), ARV stock out (37.8%), and not belonging to a support group (10.23%). Twenty eight (62.22%) subjects in the intervention group were able to take their treatment regularly and on time.Conclusion:SMS improved adherence to ARVs. Key constraints which affect adhere to ARV medication can be addressed using SMS.

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A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.9708 ◽

2017 ◽

Author(s):

Ellen Kemler ◽

Vincent Gouttebarge

Keyword(s):

Randomized Controlled Trial ◽

Injury Prevention ◽

Preventive Measures ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Prevention Measures ◽

Intention To Treat ◽

Randomized Controlled ◽

And Control

BACKGROUND Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries. OBJECTIVE The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. METHODS A randomized controlled trial with a follow-up period of 5 months will be conducted. The participants will be novice runners. At enrollment, participants will be asked to report injury-preventive measures they usually take during their running activities. After completing the enrollment questionnaire, participants will be randomized to intervention and control groups. The intervention group will have access to the RunFitCheck intervention; the control group will perform their running activities as usual. Participants will be asked to report retrospectively in detail what they have done regarding injury prevention during their running activities at 1, 3, and 5 months after enrollment. Descriptive analyses will be conducted for different baseline variables in the intervention and control group. Relative risks and 95% CIs will be used to analyze behavioral changes according to the intention-to-treat principle. RESULTS The project was funded in 2016 and enrollment was completed in 2017. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. CONCLUSIONS To nullify the negative side effects of running, prevention of training errors is desirable. As the use of injury prevention measures is not compulsory in running, a behavioral change is necessary to increase the use of effective injury-preventive measures and to prevent running-related injuries. CLINICALTRIAL Netherlands Trial Register NTR6381; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6381 (Archived by WebCite at http://www.webcitation.org/736Xjm5jv) INTERNATIONAL REGISTERED REPOR RR1-10.2196/9708

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The Effect of Pillbox Use on Medication Adherence Among Elderly Patients: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.34172/iejm.2020.07 ◽

2020 ◽

Vol 9 (1) ◽

pp. 38-43

Author(s):

Ashraf Mehdinia ◽

Marzieh Loripoor ◽

Mahlagha Dehghan ◽

Shahin Heidari

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Cardiovascular Diseases ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

The Mean ◽

Poor Medication Adherence

Background: Poor medication adherence may cause unfortunate consequences such as disease progression and even death, particularly in older adults. This study aimed to evaluate the effect of pillbox use on medication adherence among older adults with cardiovascular diseases. Materials and Methods: This study was conducted as a two-group randomized controlled trial in a clinic in Kerman, Iran in 2017. Participants included seventy patients who were randomly allocated to either a control or an intervention group. The patients in the intervention group were verbally educated to manage their medications using a pillbox for four consecutive weeks while their counterparts received their medications without the use of any drug reminders. Results: The mean score of all participants’ medication adherence was 4.02±2.19 at the beginning of the study. Medication adherence significantly improved in the intervention group during the study (P<0.001) while it remained poor in the control group (P>0.99). Finally, medication adherence was significantly better in the intervention group compared to the control group at the end of the study (P=0.001). Conclusion: In general, pillbox use can promote medication adherence in older adults with cardiovascular diseases thus it is recommended for improving medication adherence and minimizing the consequences of non-adherence.

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Methylprednisolone or Dexamethasone, Which One Is the Superior Corticosteroid in the Treatment of Hospitalized COVID-19 Patients: A Triple-Blinded Randomized Controlled Trial

10.21203/rs.3.rs-148529/v1 ◽

2021 ◽

Author(s):

Keivan Ranjbar ◽

Reza Shahriarirad ◽

Amirhossein Erfani ◽

Zohre Khodamoradi ◽

Mohammad Hasan Gholampoor Saadi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

And Control

Abstract BackgroundAlthough almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, unsolved issues remained to choose appropriate corticosteroids treatment for COVID-19. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients.MethodIn this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. Patients were randomly allocated into two groups to receive either methylprednisolone (2mg/kg/day) or dexamethasone (6mg/kg/day). Data was assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8).ResultsThere was no significant variation among the groups on the admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, P = 0.002) and day 10 (2.90 vs. 4.71, P = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group, and the control group, (3.909 vs. 4.873 respectively, P = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (P = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% P = 0.040).ConclusionIn the context of treating hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone.Trial Registration:The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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Effects of an equol-containing supplement on advanced glycation end products, visceral fat and climacteric symptoms in postmenopausal women: A randomized controlled trial

10.21203/rs.3.rs-265906/v3 ◽

2021 ◽

Author(s):

Remi Yoshikata ◽

Khin Zay Yar Myint ◽

Hiroaki Ohta ◽

Yoko Ishigaki

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Visceral Fat ◽

Controlled Trial ◽

Intervention Group ◽

Skin Aging ◽

Control Group ◽

Climacteric Symptoms ◽

Visceral Fat Area ◽

Randomized Controlled

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered a potentially effective agent for relieving climacteric symptoms, for the prevention of lifestyle-related diseases, and for aging care in postmenopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging and climacteric symptoms with respect to internally produced equol in postmenopausal women.Methods: A single-center, randomized controlled trial (registration number: UMIN000030975) on 57 postmenopausal Japanese women (mean age: 56±5.37 years) was conducted. Twenty-seven women received the equol supplement, while the remaining received control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese postmenopausal women.Results: Three months postintervention, the treatment group showed significant improvement in climacteric symptoms compared to the control group (81% vs. 53%, respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations, significant improvement in skin autofluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers.Conclusion: Women receiving equol supplementation showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously produced equol to improve skin aging and visceral fat in certain populations.

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