Effectiveness of a single education and counseling intervention in reducing anxiety in women undergoing hysterosalpingography: a randomized controlled trial.
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ABSTRACT:
SUBMITTER: La Fianza A
PROVIDER: S-EPMC3915489 | biostudies-other | 2014
REPOSITORIES: biostudies-other
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Project description:IntroductionThe COVID-19 pandemic is regarded as a serious public health concern that boosts levels of stress and anxiety which could be explained by several reasons, including social isolation. In this regard, we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.MethodsThis is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n = 267) or control (n = 269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on D1 and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group on D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction on D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherences to preventive measures during the isolation in each group.ResultsHundred and ninety-six patients in the intervention group and 206 patients in the control group completed the study. The sociodemographic, clinical, and initial anxiety level features of the intervention and control groups were comparable at baseline (p ≥ 0.05). On D7, the education group's anxiety level (HAD-A ≥ 8) decreased from 26 to 16.3% (p = 0.013) while in the control group it increased from 19.4 to 22.8% (p = 0.37). Thus, the percentage change in anxiety between D1 and D7 (delta D7 - D1) was - 9.7% in the Education group and + 3.4% in the Control group. Using the HAD-A ≥ 11 thresholds, the percentage of anxiety decreased from 15.3 to 11.2% (p = 0.26) between D1 and D7, while it increased in the control group from 9.7 to 15.7% (p = 0.045). Thus, the education group's change in anxiety (delta D7 - D1) was - 4.1%, while the control group's change was + 6%.ConclusionDuring an outbreak, providing health education to quarantined patients may be beneficial to reduce the psychological impact of the disease.Trial registration numberClinicalTrials.gov Identifier: NCT05715593, retrospectively registered on 8/02/2023 https://clinicaltrials.gov/ct2/results?term=NCT05715593&Search=Search .
| S-EPMC10280925 | biostudies-literature
Project description:BackgroundSocial inequality in smoking remains an important public health issue. Upper secondary schools offering vocational education and training (VET) comprise more students from lower socioeconomic backgrounds and have higher smoking prevalence than general high schools. This study examined the effects of a school-based multi-component intervention on students' smoking.MethodsA cluster randomized controlled trial. Eligible participants were schools offering VET basic courses or preparatory basic education in Denmark, and their students. Schools were stratified by subject area and eight schools were randomly allocated to intervention (1,160 invited students; 844 analyzed) and six schools to control (1,093 invited students; 815 analyzed). The intervention program comprised smoke-free school hours, class-based activities, and access to smoking cessation support. The control group was encouraged to continue with normal practice. Primary outcomes were daily cigarette consumption and daily smoking status at student level. Secondary outcomes were determinants expected to impact smoking behavior. Outcomes were assessed in students at five-month follow-up. Analyses were by intention-to-treat and per protocol (i.e., whether the intervention was delivered as intended), adjusted for covariates measured at baseline. Moreover, subgroup analyses defined by school type, gender, age, and smoking status at baseline were performed. Multilevel regression models were used to account for the cluster design. Missing data were imputed using multiple imputations. Participants and the research team were not blinded to allocation.ResultsIntention-to-treat analyses showed no intervention effect on daily cigarette consumption and daily smoking. Pre-planned subgroup analyses showed statistically significant reduction in daily smoking among girls compared with their counterparts in the control group (OR = 0.39, 95% CI: 0.16, 0.98). Per-protocol analysis suggested that schools with full intervention had higher benefits compared with the control group (daily smoking: OR = 0.44, 95% CI: 0.19, 1.02), while no marked differences were seen among schools with partial intervention.ConclusionThis study was among the first to test whether a complex, multicomponent intervention could reduce smoking in schools with high smoking risk. Results showed no overall effects. There is a great need to develop programs for this target group and it is important that they are fully implemented if an effect is to be achieved.Trial registrationhttps://www.isrctn.com/ISRCTN16455577 , date of registration 14/06/2018.
| S-EPMC9979485 | biostudies-literature
Project description:Gestational diabetes mellitus (GDM) is of public health concern. This trial examined whether a clinically proven lifestyle modification program (LMP) in early pregnancy was superior to routine antenatal care in improving GDM, maternal and infant outcomes. Chinese pregnant women at risk of GDM (n = 220) were recruited at or before 12-week gestation and randomized to either a LMP group or a routine care control group. Eighty subjects completed a dietitian-led LMP including dietary and exercise components from early pregnancy till 24-week gestation. Data were compared with those of 86 control subjects. Twenty three (26.7%) control subjects and 20 (25.0%) LMP subjects developed GDM (p = 0.798). The proportion of infants born large for gestational age and macrosomia was similar between groups. The LMP group showed a lower proportion of excessive gestational weight gain (GWG). Subgroup analysis suggested that those with higher LMP adherence showed more desirable dietary composition and energy intake, and lower proportion of excessive GWG compared with the low LMP adherence group and the control group. The potential effect of LMP on GDM and other maternal and infant outcomes, in particular GWG, as well as barriers for making lifestyle changes warrant further investigations (ClinicalTrials.gov NCT02368600).
| S-EPMC6138708 | biostudies-literature
Project description:Anxiety disorders are found to be the most prevalent psychological problems among children and adolescents. Cognitive behaviour therapy (CBT) was found to be effective at reducing anxiety. The purpose of this study was to assess the effectiveness of a universal school-based intervention for reducing anxiety among Grade 9 schoolchildren. A randomized controlled cluster trial was conducted by randomly assigning 36 schools in the Colombo district in Sri Lanka into study and control arms, each comprising 18 schools with 360 students. The levels of anxiety, self-esteem and depression status were assessed using the validated Screen for Child Anxiety Related Disorders (SCARED) tool and the Rosenberg self-esteem scale, respectively, and the Depression, Anxiety and Stress Scale 21 (DASS-21) at baseline, after intervention, and after 3 months. A CBT-based universal intervention package was administered weekly by a trained teacher for eight weeks with a one-month self-practice period to a randomly selected Grade 9 class in each school in the study arm. The control arm received routine care. Anxiety and self-esteem scores and depression status were compared between the two arms after the intervention and at 3 months of follow-up using the generalized estimation equation (GEE), controlling for confounding and clustering. The nonresponse and loss to follow-up rates were < 1%. When comparing the study arm with the control arm using GEE, anxiety levels were significantly lower [β = (-0.096), 95% CI = (-0.005) - (-0.186), p = 0.038] at follow-up but not postintervention [β = (-0.024), 95% CI = 0.006 - (-0.055), p = 0.115]. There were no significant differences in depression status after intervention (OR = 0.257, 95% CI =0.052-1.286; p = 0.098) or follow-up (OR = 0.422, 95% CI 0.177-1.008; p = 0.052), and self-esteem significantly increased after intervention (β = 0.811, 95% CI = 0.314-1.309; p = 0.001) but not at follow-up [β=0.435, 95% CI=(-0.276)-1.145, p=0.231]. This study revealed that the universal package based on CBT is effective at reducing anxiety and improving self-esteem among adolescents. The trial registration number and date were SLCTR/2018/018 and 19th of June 2018 respectively.
| S-EPMC11366126 | biostudies-literature
Project description:BackgroundDepression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited.ObjectiveThis study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence.MethodsIn an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed.ResultsOf the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI -0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: -67.23%, P<.001, CG: -82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07).ConclusionsThe Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw).
| S-EPMC5491897 | biostudies-literature
Project description:Objective. To test the effectiveness of guided imagery (GI) and progressive muscle relaxation (PMR) as stress reducing interventions in patients with prostate and breast cancer who undergo chemotherapy. Methods. Patients were randomly assigned to either the control group or the intervention group (PMR and GI). Patients were observed for a total duration of 3 weeks and assessed with the SAS and BECK-II questionnaires for anxiety and depression, respectively, in addiotion to two biological markers (saliva cortisol and saliva amylase) (trial registration number: NCT01275872). Results. 256 patients were registered and 236 were randomly assigned. In total 104 were randomised to the control group and 104 to the intervention group. Intervention's mean anxiety score and depression score changes were significantly different compared to the control's (b = -29.4, p < 0.001; b = -29.4, p < 0.001, resp.). Intervention group's cortisol levels before the intervention (0.30 ± 0.25) gradually decreased up to week 3 (0.16 ± 0.18), whilst the control group's cortisol levels before the intervention (0.21 ± 0.22) gradually increased up to week 3 (0.44 ± 0.35). The same interaction appears for the Amylase levels (p < 0.001). Conclusions. The findings showed that patients with prostate and breast cancer undergoing chemotherapy treatment can benefit from PMR and GI sessions to reduce their anxiety and depression.
| S-EPMC4545275 | biostudies-literature
Project description:Evidence regarding what comprises effective education for acne vulgaris patients is lacking. Internet-based education may improve patient knowledge of this condition.Our objective was to compare the effectiveness of standard web-based education and an automated counseling website in improving acne knowledge.In a randomized trial, participants visited either a standard website or an automated counseling website to learn about acne. Multiple-choice questions were administered at baseline and after 12 weeks to assess change in acne knowledge.A total of 97 high school students were enrolled, and 95 completed the study. The standard website group had a significant increase in knowledge from baseline (3.61 ± 1.22) to 12-week follow-up (5.46 ± 1.31, p < 0.001). Similarly, the automated counseling website group had a significant increase in knowledge between both time points (3.53 ± 1.50 vs. 6.49 ± 1.06, p < 0.001). After 12 weeks, mean improvement in knowledge was higher in the automated counseling group (2.96 ± 1.85) than in the standard website group (1.85 ± 1.46, d = 0.67, p = 0.002). The number of website visits was positively correlated with improvement in knowledge in both groups. Finally, the automated counseling website group rated their educational material more useful (p = 0.004) and more enjoyable to view (p = 0.003) than did the standard website group.This study is limited to adolescents with mild-to-moderate acne vulgaris.Internet-based patient education appears to be an effective method of improving acne knowledge among adolescents.
| S-EPMC4591056 | biostudies-literature
Project description:In-person education and counseling for all people receiving genetic results is the predominant model of disclosure but is challenged by the growing volume of low-impact results generated by sequencing. Evidence suggests that web-based tools may be as effective as in-person counseling at educating individuals about their low-impact results. However, the effects of counseling have not been assessed. To evaluate its utility, carrier results were returned to 459 post-reproductive participants from the ClinSeq cohort within a randomized controlled trial. Participants received education and were randomized to receive counseling or not. Primary outcomes included risk worry, test-related positive experiences, attitudes, and decisional conflict. Secondary outcomes were satisfaction, preferences, and counseling value. There were no differences between participants who received counseling and those who did not in the primary outcomes. Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high. Most participants (92%) randomized to counseling preferred it and valued it because it provided validation of their reactions and an opportunity for interpersonal interaction. Web-based tools address the challenge of returning low-impact results, and these data provide empiric evidence that counseling, although preferred and satisfying, is not critical to achieving desired outcomes.
| S-EPMC5985358 | biostudies-literature
Project description:BackgroundThe potential benefit of eHealth interventions in patients with abdominal aortic aneurysm (AAA) is uncertain. The primary aim of this study was to investigate the effect of an eHealth intervention on anxiety in patients with AAA undergoing surgery.MethodsA single-centre randomized clinical trial of patients with AAA scheduled for surgical repair was undertaken. The intervention group received an eHealth tool and psychosocial support besides standard care. The control group received standard care. The analysis of treatment effects was performed as intention-to-treat and per protocol analysis. The primary outcome measure was anxiety mean score (Hospital Anxiety and Depression Scale Anxiety (HADS)-A). Secondary outcomes measures were HADS Depression and short-form 12-item health survey mean scores.ResultsSome 120 participants were randomized. No effect on anxiety mean scores was found in the intention-to-treat analysis (-1.21 versus -0.54, P = 0.330). Among those randomized to the intervention, only 30 of 60 participants used the eHealth tool (application (app) users). The app users were younger and had a higher educational level. A decrease in anxiety mean scores was noted in those who used the app in the per protocol analysis (-2.00 versus -0.54, P = 0.028). The intervention group stated a lower physical-component health-related quality of life (HRQoL) (-4.32 versus -1.16, P = 0.042) but mental-component HRQoL and depressive symptoms were unchanged.ConclusionsDelivery of an eHealth intervention in this RCT did not result in an improvement in anxiety scores in patients awaiting AAA surgery. Uptake of the eHealth tool was low, although it resulted in lower anxiety scores in those participants who actually used it.Clinical trial registration numberNCT03157973 (http://www.clinicaltrials.gov).
| S-EPMC10364917 | biostudies-literature
Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.
| S-EPMC2219825 | biostudies-other