Changes in the cortisol and oxytocin levels of first-time pregnant women during interaction with an infant: a randomized controlled trial

Abstract Background During pregnancy, physiological, psychological, and social changes affect pregnant women’s childcare anxiety and childrearing behavior. However, there are scarce reports on hormonal evaluation related to such anxiety and behavior. Herein, we evaluated changes in salivary cortisol (primary outcome) and oxytocin (secondary outcome) levels of first-time pregnant women when interacting with an infant and discussed the relation of these changes to the women’s stress level. Methods This was a two-arm randomized controlled trial. Participants were randomly assigned using a web-based randomization system. The experimental group involved interaction with an infant for 30 min. The control group involved watching a DVD movie of an infant for 30 min. Saliva samples were collected at preintervention and postintervention. Saliva samples were assayed, and all data were compared between and within the groups using independent t-test and paired t-test with a two-sided 5% significance level. This study was approved by the Research Ethics Committee of St. Luke’s International University. Results A total of 102 women were randomly assigned to the experimental (n = 51) and control (n = 51) groups. Finally, 38 women in the experimental group and 42 women in the control group were analyzed. The salivary cortisol level significantly decreased after the interventions in both groups (t = 4.57, p = 0.00; t = 5.01, p = 0.00). However, there were no significant differences in the salivary cortisol (t = 0.349, p = 0.73) and oxytocin (t = − 1.945, p = 0.58) levels between the two groups. Conclusions The salivary cortisol level of first-time pregnant women significantly decreased in the experimental and control groups postintervention, although no significant difference was found between the two groups. Such decrease indicates stress reduction and release among these women. The absence of a significant increase in salivary oxytocin level in both groups may be related to the limitations of an insufficient number of samples that could be analyzed owing to the small saliva volume in some samples and the lack of adequate tactile stimulation of the intervention protocol. These results and procedural limitations provide useful insights into approaching subsequent studies aiming at continuously optimizing detection procedures. Trial registration UMIN000028471 (Clinical Trials Registry of University Hospital Information Network. July 31, 2017- Retrospectively registered.

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The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

10.21203/rs.2.12387/v2 ◽

2019 ◽

Author(s):

Esther Steenaart ◽

Rik Crutzen ◽

Math JJM Candel ◽

Nanne K de Vries

Keyword(s):

Randomized Controlled Trial ◽

Organ Donation ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Cluster Randomized ◽

And Control ◽

Experimental Group

Abstract Background: Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e. the primary outcome in the study at hand) and beliefs regarding organ donation. Methods: The effectiveness was investigated in a post-test only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for intermediate vocational education who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-minute lessons. Results: A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR=1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B=.62; 95%CI [.23-1.01]) and they had higher intentions to talk to family members (B=.68; 95%CI [.28-1.08]) and friends (B=.36; 95%CI [.07-.66]) about organ donation. There were no effects on the choice students intended to register (OR=1.08; 95%CI [.67-1.73]). Conclusions: Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration: The Dutch Trial Register, NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

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Contributions of auriculotherapy in smoking cessation: a pilot study

Revista da Escola de Enfermagem da USP ◽

10.1590/s0080-6234201400005000015 ◽

2014 ◽

Vol 48 (5) ◽

pp. 883-890

Author(s):

Roberta de Paiva Silva ◽

Erika de Cássia Lopes Chaves ◽

Sandra Cristina Pillon ◽

Andréia Maria Silva ◽

Denis da Silva Moreira ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Pilot Study ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Future Studies ◽

Randomized Controlled ◽

And Control ◽

Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

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A randomized controlled trial of the effects of antenatal milk expression on breastfeeding among first-time mothers in China

10.21203/rs.3.rs-42871/v1 ◽

2020 ◽

Author(s):

yan chen ◽

Li-Ping Meng ◽

Jiao-Jiao Zhang ◽

Hong-Hua Guo ◽

hongyu zhang

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Exclusive Breastfeeding ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

First Time Mothers ◽

First Time

Abstract Background Limited research outside China suggest that antenatal milk expression in late pregnancy (AME) may promote breastfeeding. A few studies have evaluated the safety and efficacy of AME in women with diabetes in pregnancy, little or no evidence exists to explore its effects on breastfeeding self-efficacy and early breastfeeding, particularly in first-time mothers. The objective of this study was to explore the effect of AME on breastfeeding for the first-time mothers during the postpartum hospitalization. Methods A randomized controlled trial was conducted in a tertiary hospital in Haikou, Hainan. We recruited pregnant women who had completed 37 weeks of gestation and randomly assigned them to either the intervention group (n = 45) or the control group (n = 45). The pregnant women in the intervention group were advised to rhythmic self-massage of breasts three times daily at any time. The control group was given routine midwifery and obstetric care. The breastfeeding self-efficacy scale(BSES)was used to measure the self-efficacy of breastfeeding at 37 weeks, 38 weeks and the third day postpartum. The time to lactogenesis II and the rate of exclusive breastfeeding was measured three times every day by the researcher in the ward. Results Compared with the control group, the intervention group had higher breastfeeding self-efficacy scores measured by the scale of BSES(P < 0.05), the intervention group had higher exclusive breastfeeding rate on the first day, second day, third-day postpartum, and the difference was statistically significant༈P < 0.05). The time to lactogenesis II in the intervention group was earlier than that in the control group(P < 0.05). Conclusions Antenatal breast milk expression at term improved the confidence in the ability to breastfeed and produce milk postpartum, thus significantly improving the behavior of exclusive breastfeeding, and increasing the percentage of breastfed infants during their hospital stay, these infants were able to avoid infant formula milk in this important early period.

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The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

Trials ◽

10.1186/s13063-019-3882-6 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Esther Steenaart ◽

Rik Crutzen ◽

Math J. J. M. Candel ◽

Nanne K. de Vries

Keyword(s):

Randomized Controlled Trial ◽

Organ Donation ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Cluster Randomized ◽

And Control ◽

Experimental Group

Abstract Background Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e., the primary outcome in the study at hand) and beliefs regarding organ donation. Materials and methods The effectiveness was investigated in a post-test-only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for Intermediate Vocational Education who taught a course on Citizenship delivered three intervention elements (i.e., video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-min lessons. Results A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR = 1.81; 95%CI [1.10–2.96]), their perceived knowledge was higher (B = 0.62; 95%CI [0.23–1.01]) and they had higher intentions to talk to family members (B = 0.68; 95%CI [0.28–1.08]) and friends (B = 0.36; 95%CI [0.07–0.66]) about organ donation. There were no effects on the choice students intended to register (OR = 1.08; 95%CI [0.67–1.73]). Conclusions Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger-scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration The Dutch Trial Register, ID: NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

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Reducing Pain after Second Trimester Genetic Amniocentesis by Postprocedural Cryotherapy: A Randomized Controlled Trial

Journal of the Medical Association of Thailand ◽

10.35755/jmedassocthai.2021.08.12338 ◽

2021 ◽

Vol 104 (8) ◽

pp. 1235-1240

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Pain Perception ◽

Controlled Trial ◽

University Hospital ◽

Control Group ◽

Second Trimester ◽

Randomized Controlled ◽

Genetic Amniocentesis ◽

And Control

Objective: To evaluate the effectiveness of cryotherapy on pain reducing after the second trimester genetic amniocentesis. Materials and Methods: A prospective randomized controlled trial was performed at Maternal-Fetal-Medicine (MFM) Unit at Thammasat University Hospital, Thailand between December 2019 and March 2020. The participants were pregnant women who underwent amniocentesis for genetic evaluation during the study period were divided into two groups, study and control. After finishing amniocentesis, study and control groups received jelly pack at temperature 4-degree Celsius and room temperature, respectively. The pain measurement was 10-cm visual analog scale (VAS) before, during, and 15 and 30 minutes after amniocentesis. Demographic characters and VAS score were recorded and evaluated. Results: Two hundred forty pregnant women between 15 and 22 weeks of gestation were recruited and equally allocated into two groups. There were no differences between the two group in demographic data, indication, anticipated, and actual pain scores (p=0.327 and 0.401, respectively). Median pain score at 15 and 30 minutes after the procedure in the study group were 1 and 0 (p=0.202) while in the control group it was 2 and 1 (0.039). Patients’ satisfaction after finishing the procedure was not significantly different. Conclusion: Cryotherapy was effective in decreasing maternal pain perception after amniocentesis. Keywords: Pregnancy; Amniocentesis; Cold pack; Cryotherapy; Pain

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Metabolic resuscitation therapy in critically Ill patients with sepsis and septic shock: A Prospective Randomized Controlled Trial

10.21203/rs.3.rs-140461/v1 ◽

2021 ◽

Author(s):

Fang Feng ◽

Huyong Yang ◽

Weiwei Yang ◽

Min Li ◽

Yu Chen

Keyword(s):

Septic Shock ◽

Randomized Controlled Trial ◽

Mortality Rate ◽

Controlled Trial ◽

Control Group ◽

Icu Mortality ◽

Randomized Controlled ◽

Sepsis And Septic Shock ◽

And Control ◽

Experimental Group

Abstract ObjectiveTo further clarify the effectiveness and potential pathophysiological principles of metabolic resuscitation therapy in critically ill patients with sepsis and septic shock.MethodsProspective randomized controlled trial. Patients with sepsis and septic shock who were admitted to the ICU from Sep. 2019 to Mar. 2020 were prospectively enrolled. According to the computerized random sequence table, patients were randomly divided into the experimental group and the control group. All patients with sepsis were included in the research of cluster of initial therapy. The experimental group received metabolic resuscitation: vitamin C (1.5 g in an intravenous infusion q6h for 3 days), vitamin B1 (200 mg in an intramuscular injection q12h for 3 days), and hydrocortisone (50 mg in an intravenous infusion q6h for 7 days).ResultsOne hundred thirty-six patients with sepsis and septic shock were included in our study. Pneumonia was the main cause of sepsis and septic shock, including 33 (49%) and 41 (60%) patients in the experimental group and control group, respectively, and gram-negative bacilli were the main pathogenic bacteria (112/136, 82.4%). The ICU length of stay for the experimental group and the control group was 9 (7–12) and 11 (9–14) days, respectively, P = 0.002. The duration of vasoactive drugs (hours) was 20.8 ± 9.9 and 46.7 ± 12.8, respectively, P༜0.001. The 6-hour lactate clearance rate was 66.2% (55.5, 76.7) and 30.1% (15.6, 50) in the experimental group and control group, respectively, P = 0.000. The 72-hour PCT clearance rate was 70% (57.5, 80.3) and 40.7% (24.8, 52.2), respectively, P = 0.001. The ICU mortality rate was 8.8% (6/68) and 15% (15/68), respectively, P = 0.033.ConclusionsMetabolic resuscitation therapy is beneficial for patients with sepsis and septic shock, shortening the length of ICU stay, reducing the duration of vasopressor use, and reducing the ICU mortality rate of patients with sepsis and septic shock. However, large, multi-center, prospective randomized controlled trials are needed to further verify these results.Trial registrationChiCTR, ChiCTR1900026084. Registered 20 September 2019 - prospective registered, http://www.chictr.org.cn/edit.aspx?pid=40910&htm=4

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

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Asieh Mehdipour ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Maryam Dastoorpoor

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Moderate Depression ◽

Before And After ◽

The Mean ◽

And Control

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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The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.98256 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Maryam Montazeri ◽

Khalil Esmaeilpour ◽

Sakineh Mohammad-Alizadeh-Charandabi ◽

Sevda Golizadeh ◽

Mojgan Mirghafourvand

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Block Design ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Writing Therapy ◽

Randomized Block Design ◽

Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

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Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

Journal of the Medical Association of Thailand ◽

10.35755/jmedassocthai.2021.06.12341 ◽

2021 ◽

Vol 104 (6) ◽

pp. 887-894

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Adjuvant Chemotherapy ◽

Energy Conservation ◽

Cancer Patients ◽

Controlled Trial ◽

Control Group ◽

Breast Cancer Patients ◽

Randomized Controlled ◽

Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

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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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