scholarly journals Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

2018 ◽  
Author(s):  
Mie de Wolff ◽  
Marianne Johansen ◽  
Anne Schoedt Ersboell ◽  
Susanne Rosthoej ◽  
Anne Brunsgaard ◽  
...  
Keyword(s):  
Chronic Disease ◽  
Pregnant Women ◽  
Chronic Diseases ◽  
Maternity Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Well Being ◽  
Randomized Controlled ◽  
Care Intervention

Abstract Background: The number of women of childbearing age with chronic diseases is rising. The risk of obstetric complications and poor psychological well-being is higher among these women, and research is needed to investigate how to meet the obstetric and psychological needs of this group during pregnancy and in the postpartum period. Previous research has shown that care coordination, continuity of care, woman-centered care and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes, pregnancy outcomes, and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases. Methods: This two-arm parallel group RCT study will be conducted from October 2018 – June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; 274 women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: 1. Coordinated and individualized care, 2. Additional ante- and postpartum consultations, and 3. Specialized midwives. The primary outcome is length of hospital stay (LOS) during pregnancy and in the postpartum period and secondary outcomes are: psychological well-being (the five-item World Health Organization Well-being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (the 12-Item Short Form Survey), patient satisfaction (The Pregnancy and Childbirth Questionnaire), and number of antenatal visits. Explorative outcomes will be pregnancy and delivery outcomes. Data is collected via patient-administered questionnaires and from medical records. Discussion: This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra- and postpartum care for women with chronic disease is founded. Trial Registration: ClinicalTrials.gov: NCT03511508. Registered June 22, 2018 Keywords: Pregnancy, chronic disease, midwifery, maternity care, antenatal care, psychological well-being, complex intervention

scholarly journals Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

2019 ◽  
Author(s):  
Mie de Wolff ◽  
Marianne Johansen ◽  
Anne Schoedt Ersboell ◽  
Susanne Rosthoej ◽  
Anne Brunsgaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Chronic Diseases ◽  
Maternity Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Pregnancy And Postpartum

Abstract Background and objectives: The number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes, pregnancy outcomes, and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases. Methods/design: This two-arm parallel group RCT study will be conducted from October 2018 – June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: 1. Coordinated and individualized care, 2. Additional ante- and postpartum consultations, and 3. Specialized midwives. The primary outcome is length of hospital stay (LOS) during pregnancy and postpartum period and secondary outcomes are: psychological well-being (the five-item World Health Organization Well-being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (the 12-Item Short Form Survey), patient satisfaction (The Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data is collected via patient-administered questionnaires and medical records. Discussion: This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra- and postpartum care for women with chronic disease is founded.

scholarly journals Effects of a Midwife-Coordinated Maternity Care Intervention (ChroPreg) vs. Standard Care in Pregnant Women with Chronic Medical Conditions: Results from a Randomized Controlled Trial

2021 ◽  
Vol 18 (15) ◽  
pp. 7875
Author(s):  
Mie G. de Wolff ◽  
Julie Midtgaard ◽  
Marianne Johansen ◽  
Ane L. Rom ◽  
Susanne Rosthøj ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Maternity Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Chronic Medical Conditions ◽  
Medical Conditions ◽  
Randomized Controlled ◽  
Individualized Care ◽  
Care Intervention

The proportion of childbearing women with pre-existing chronic medical conditions (CMC) is rising. In a randomized controlled trial, we aimed to evaluate the effects of a midwife-coordinated maternity care intervention (ChroPreg) in pregnant women with CMC. The intervention consisted of three main components: (1) Midwife-coordinated and individualized care, (2) Additional ante-and postpartum consultations, and (3) Specialized known midwives. The primary outcome was the total length of hospital stay (LOS). Secondary outcomes were patient-reported outcomes measuring psychological well-being and satisfaction with maternity care, health utilization, and maternal and infant outcomes. A total of 362 women were randomized to the ChroPreg intervention (n = 131) or Standard Care (n = 131). No differences in LOS were found between groups (median 3.0 days, ChroPreg group 0.1% lower LOS, 95% CI −7.8 to 7%, p = 0.97). Women in the ChroPreg group reported being more satisfied with maternity care measured by the Pregnancy and Childbirth Questionnaire (PCQ) compared with the Standard Care group (mean PCQ 104.5 vs. 98.2, mean difference 6.3, 95% CI 3.0–10.0, p < 0.0001). In conclusion, the ChroPreg intervention did not reduce LOS. However, women in the ChroPreg group were more satisfied with maternity care.

scholarly journals The Influence of Connectedness to Nature on Psychological Well-Being: Evidence from the Randomized Controlled Trial Play&Grow

Challenges ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 12
Author(s):  
Tanja Sobko ◽  
Gavin T. L. Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Young Children ◽  
Psychological Health ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Path Model ◽  
Psychological Well Being ◽  
Connectedness To Nature ◽  
Randomized Controlled

Urbanized children today have fewer opportunities to interact with nature which may lead to a greater risk of mental health problems. The objective of this randomized controlled trial was to investigate which particular changes in connectedness to nature (CN) would improve psychological well-being (PW) in young children. Six hundred and thirty-nine preschoolers (52.0% boys, age 34.9 ± 9.5 months) participated in Play&Grow, an early environmental education intervention. Children’s CN and PW were evaluated by parents before and after the program with validated measures; the CNI-PPC (four factors) and the SDQ, Strength and Difficulties questionnaire (five factors), respectively. The effectiveness of the intervention on the primary outcomes (CN, PW) as well as the relationship between them was analyzed in a repeated measures path model with intervention status as a causal predictor. Specific CN factors consistently increased ProSocial behavior and reduced Hyperactivity and Emotional problems. In summary, this study showed that the previously reported impact shifted from the total CN score to the specific CN factors. The Play&Grow intervention positively increased children’s CN and improved some aspects of psychological well-being in children which is a preliminary evidence of developmental benefits of connecting young children with nature. Our results indicate promising direction of action for the improvement of families’ psychological health.

scholarly journals Effects of self-conditioning techniques in promoting weight loss in patients with severe obesity: a randomized controlled trial protocol

2017 ◽  
Vol 4 (1) ◽  
pp. 20 ◽  
Author(s):  
Simona Bo ◽  
Farnaz Rahimi ◽  
Bice Properzi ◽  
Giuseppe Regaldo ◽  
Ilaria Goitre ◽  
...  
Keyword(s):  
Weight Loss ◽  
Standard Care ◽  
Traditional Approach ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Rapid Induction ◽  
Conditioning Approach

<p><strong>Background:</strong> Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesity</p><p><strong>Methods: </strong>This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m<sup>2</sup>), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.</p><p>Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.</p><p><strong>Conclusions: </strong>The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.<strong></strong></p>

Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 938-947 ◽  
Author(s):  
Mehdi Zemestani ◽  
Sharmin Mozaffari
Keyword(s):  
Emotion Regulation ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Psychological Flexibility ◽  
Well Being ◽  
Control Group ◽  
Psychological Well Being ◽  
Randomized Controlled ◽  
Acceptance And Commitment ◽  
Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

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