scholarly journals Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

2020 ◽  
Author(s):  
Margrete Mangset ◽  
Gabriele Kitzmüller ◽  
Anne Evju ◽  
Sanne Angel ◽  
Lena Aadal ◽  
...  
Keyword(s):  
Intervention Group ◽  
Well Being ◽  
Safety Net ◽  
Adjustment Process ◽  
Control Group ◽  
Structured Interviews ◽  
Control Group Design ◽  
Design Assessment ◽  
Stroke Treatment ◽  
Critical Components

Abstract Background The use of a control group is one of the most critical components of an RCT. The control conditions may change over time and include assessment interviews and standard stroke treatment. Therefore, the control group should be monitored and described in as much detail as the intervention group. It is important to find ways to reduce the risk of study-induced influence on the members of the control group. The aim of this study was to explore the possible influence of the assessment interviews on the adjustment of the members of a control group in an RCT exploring psychosocial well-being following stroke. Methods Fifteen participants in the control group of the RCT, six women and nine men, aged 29-88 years, were interviewed in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived influence of the assessment interviews on the control group varied considerably. Two different themes with subthemes were identified, describing the influence of the assessment interviews in the control group. Theme one described how participants emphasized the perceived influence of the assessment interviews that served as a safety net, enhanced their awareness and understanding, facilitated their adjustment after stroke, encouraged them to seek support, and allowed them to vent their disappointment of having been allocated to the control group. Theme two described participants’ experiences of handling their adjustment process on their own without describing any influence of the assessment interviews on their condition. These participants highlighted mild strokes, spontaneous recovery, setting own goals, support from family and friends and supporting research. Conclusions In view of the design challenges in RCTs, it seems important to explore in depth how to design assessment interviews with control group members without introducing risk of bias, and to uphold rigor and stringency in the trials.

scholarly journals Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Margrete Mangset ◽  
Gabriele Kitzmüller ◽  
Anne S. Evju ◽  
Sanne Angel ◽  
Lena Aadal ◽  
...  
Keyword(s):  
Usual Care ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Well Being ◽  
Safety Net ◽  
Adjustment Process ◽  
Control Group ◽  
Structured Interviews ◽  
Rehabilitation Research ◽  
Main Challenge

Abstract Background A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is “usual care.” The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants’ reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. Methods Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants’ feelings of control and their ability to cope. Other participants’ statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. Conclusions RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. Trial registration ClinicalTrials.gov NCT02338869. Registered on October 4, 2014

scholarly journals The Influence of Forest Activities in a University Campus Forest on Student’s Psychological Effects

2021 ◽  
Vol 18 (5) ◽  
pp. 2457
Author(s):  
Jin Gun Kim ◽  
Jinyoung Jeon ◽  
Won Sop Shin
Keyword(s):  
Stress Response ◽  
Mood State ◽  
Intervention Group ◽  
Well Being ◽  
Psychological Effects ◽  
Control Group ◽  
Subjective Well Being ◽  
Control Group Design ◽  
Post Test ◽  
Forest Activities

This study aimed to examine the psychological effects of forest activities in a campus forest. A pre-test and post-test control group design was employed to evaluate the psychological effect of forest activities in a campus forest. A total of 38 participants participated in this study (19 in the forest activities group; 19 in the control group). The Profile of Mood State (POMS) questionnaire, the Concise Measure of Subjective Well-Being (COMOSWB), and the modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects. This study revealed that participants in the forest activities intervention group had significantly positive increases in their mood, stress response, and subjective well-being, comparing with those of control group participants who did not partake in any forest activities. In conclusion, the implementation of forest activities in a campus forest is an efficient strategy to provide psychological well-being benefits to college students.

Clowns in Paediatric Surgery: Less Anxiety and More Oxytocin? A Pilot Study

2017 ◽  
Vol 229 (05) ◽  
pp. 274-280
Author(s):  
Tabea Scheel ◽  
Dorothea Hoeppner ◽  
Anne Grotevendt ◽  
Winfried Barthlen
Keyword(s):  
Pilot Study ◽  
Positive Impact ◽  
Intervention Group ◽  
Well Being ◽  
Ward Round ◽  
Control Group ◽  
Hospitalized Children ◽  
Paediatric Surgery ◽  
Control Group Design ◽  
Positive Effects

Abstract Background Hospital stays and medical interventions are accompanied by worries and anxiety in children and parents. Recent studies show that hospital clowns may reduce anxiety and enhance well-being. However, so far studies are based solely on subjective measures and clowns are usually not integrated in medical routine. With this pilot study, we aim to provide both psychological and physiological evidence of positive effects of clowns’ interventions in hospitalized children. Patients/Method In a consecutive randomized intervention-control group design with 31 children aged 4 to 13 years, 17 patients were accompanied by a clown prior to surgery or during ward round (intervention group) and 14 were not (control group). Saliva samples for oxytocin measurement were taken from all patients before hospitalization (T1) and prior to surgery or after ward round (T2). Self- and parents-reports were obtained at T1, T2 as well as at time of discharge from hospital (T3) regarding children’s anxiety (STAI), worries and well-being. Clowns evaluated their success in cheering up the child. Health professionals were asked for their acceptance of clowns in hospitals. Results Children in the intervention group had lower anxiety ratings and a higher oxytocin concentration at T2 as compared with T1; the control group showed no changes. Parents rated the well-being of their children higher if their child had clown’s contact and were more willing to recommend the hospital. The staff judged the clowns as helpful for patients. Discussion Consistent psychological and physiological results suggest the positive impact of a clown’s intervention in hospitalized children.

scholarly journals EFEK RELAKSASI AUTOGENIC TRAINING TERHADAP KEBERHASILAN MASA AWAL LAKTASI PADA IBU POSTPARTUM

2021 ◽  
Vol 5 (2) ◽  
pp. 48
Author(s):  
Iis Sri Hardiati
Keyword(s):  
Relaxation Training ◽  
Assessment Tool ◽  
Intervention Group ◽  
Self Care ◽  
Well Being ◽  
T Test ◽  
Autogenic Training ◽  
Control Group ◽  
Control Group Design ◽  
Group Design

Salah satu penyebab kegagalan menyusui pada ibu antara lain kurangnya kepercayaan diri pada ibu. Relaksasi autogenic training (RAT) merupakan metode untuk meningkatkan rasa percaya diri dan membangun pikiran positif ibu.  Hal ini sesuai dengan teori keperawatan self-care dari Orem yang bertujuan membantu ibu mencapai kemandirian untuk mempertahankan hidup, kesehatan, perkembangan, dan kesejahteraan. Tujuan penelitian: Penelitian ini bertujuan untuk mengetahui efek RAT terhadap keberhasilan menyusui pada ibu postpartum.  Metode: Desain penelitian ini menggunakan quasi experiment dengan rancangan nonequivalent control group design.  Sampel terdiri dari masing-masing 15 responden untuk kelompok intervensi dan kelompok kontrol.  RAT diberikan melalui media audio voice selama 10-15 menit sebanyak 2-3 kali sehari selama 7 hari.  Posttest dilakukan dengan cara observasi melalui kunjungan pada hari ketujuh. Instrumen Via Christi Breastfeeding Assessment Tool yang telah valid dan reliabel digunakan untuk menilai keberhasilan menyusui. Analisis data menggunakan t-test. Hasil: ibu yang melakukan RAT bisa menyusui lebih efektif dibanding kelompok kontrol (p=0,000). Diskusi: RAT memberikan ketenangan dan kemudahan kepada responden dalam membantu meningkatkan keberhasilan menyusui karena memiliki efek relaksasi. Kesimpulan: RAT efektif terhadap keberhasilan menyusui. Oleh karena itu RAT dapat digunakan oleh perawat sebagai sebuah asuhan keperawatan dalam program dukungan ibu menyusui di rumah sakit atau fasilitas kesehatan.Kata Kunci: autogenic training, menyusui, relaksasi Relaxation Effects of Autogenic Training on Lactation Success in Post Partum Mothers ABSTRACTOne of the causes of failure to breastfeed, among others, is a lack of confidence in mothers. Autogenic relaxation training (RAT) is a method to increase self-confidence and build positive thoughts for mothers. This is in accordance with Orem's self-care nursing theory, which aims to help mothers achieve independence to maintain life, health, development, and well-being. Objective: This research aims to reveal the effect of RAT on breastfeeding success in postpartum mothers. Methods: This research employed a quasi-experimental design with a nonequivalent control group design. The samples consisted of an intervention group and a control group, with 15 respondents for each. RAT was given through audio voice media for 10-15 minutes 2-3 times a day for 7 days. The posttest was conducted using observation through visits on the seventh day. A valid and reliable instrument of the Via Christi Breastfeeding Assessment Tool was used to assess breastfeeding success. Data were analyzed using a t-test. Results: Mothers who did RAT could breastfeed more effectively than the control group (p=0.000). Discussion: RAT provides comfort and convenience to respondents in helping to increase breastfeeding success because it has a relaxing effect. Conclusion: RAT is effective for breastfeeding success. Therefore, nurses can use RAT as nursing care in breastfeeding mother support programs in hospitals or health facilities.Keywords: autogenic training, breastfeeding, relaxation

scholarly journals The effect of an online individualized program to prevent nurse burnout – a mixed method study

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Nina Geuens ◽  
Erik Franck ◽  
Peter Vlerick ◽  
Peter Van Bogaert
Keyword(s):  
Mixed Method ◽  
Intervention Group ◽  
Well Being ◽  
Personal Accomplishment ◽  
Mixed Method Study ◽  
Control Group ◽  
Preventive Program ◽  
Control Group Design ◽  
Content Type ◽  
Nurse Burnout

PurposePreventing burnout and promoting psychological well-being in nurses are of great importance. In this study the effect of an online, stand-alone individualized preventive program for nurse burnout based on cognitive behavioral therapy (CBT) is described and explained.Design/methodology/approachA mixed method study with an explanatory sequential design was applied. Quantitative data were collected from September 2015 to March 2016 during an intervention study with a pretest-posttest wait-list control group design within a population of hospital nurses in the Dutch speaking part of Belgium. Consecutively, 13 nurses from the intervention group who fully completed the program were interviewed.FindingsAll interviewed participants experienced some sort of effect due to working with the program. Emotional exhaustion remained stable in the intervention group and increased in the control group. However, this difference was not significant. Personal accomplishment decreased significantly within the intervention group when compared to the control group. This might be explained by the self-awareness that was created through the program, which confronted participants with their weaknesses and problems.Originality/valueThis study adds to the understanding of online individual burnout prevention. The results suggest the feasibility of an online program to prevent nurse burnout. This could be optimized by complementing it with organizational interventions, introducing refresher courses, reminders and follow-up. Furthermore, additional attention should be devoted to preparing the implementation in order to minimize attrition rates.

A Pilot Study on the Efficacy of Volunteer Mentorship for Young Adults With Self-Harm Behaviors Using a Quasi-Experimental Design

Crisis ◽  
2016 ◽  
Vol 37 (6) ◽  
pp. 415-426 ◽  
Author(s):  
Yik-Wa Law ◽  
Paul S. F. Yip ◽  
Carmen C. S. Lai ◽  
Chi Leung Kwok ◽  
Paul W. C. Wong ◽  
...  
Keyword(s):  
Experimental Design ◽  
Suicide Ideation ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Treatment As Usual ◽  
Prevention Services ◽  
Quasi Experimental ◽  
Self Harm ◽  
Volunteer Support

Abstract. Background: Studies have shown that postdischarge care for self-harm patients is effective in reducing repeated suicidal behaviors. Little is known about whether volunteer support can help reduce self-harm repetition and improve psychosocial well-being. Aim: This study investigated the efficacy of volunteer support in preventing repetition of self-harm. Method: This study used a quasi-experimental design by assigning self-harm patients admitted to the emergency departments to an intervention group with volunteer support and treatment as usual (TAU) for 9 months and to a control group of TAU. Outcome measures include repetition of self-harm, suicidal ideation, hopelessness, and level of depressive and anxiety symptoms. Results: A total of 74 cases were recruited (38 participants; 36 controls). There were no significant differences in age, gender, and clinical condition between the two groups at the baseline. The intervention group showed significant improvements in hopelessness and depressive symptoms. However, the number of cases of suicide ideation and of repetition of self-harm episodes was similar for both groups at the postintervention period. Conclusion: Postdischarge care provided by volunteers showed significant improvement in hopelessness and depression. Volunteers have been commonly involved in suicide prevention services. Further research using rigorous methods is recommended for improving service quality in the long term.

SUPPORTIVE EDUCATIVE SYSTEM DALAM MENINGKATKAN KEMANDIRIAN MERAWAT KAKI PADA PASIEN DIABETES MELLITUS TIPE II

2019 ◽  
Vol 9 (2) ◽  
pp. 63-72
Author(s):  
Nova Nurwinda Sari ◽  
Herlina Herlina
Keyword(s):  
Diabetes Mellitus ◽  
Health Center ◽  
Intervention Group ◽  
T Test ◽  
Control Group ◽  
P Value ◽  
Type Ii ◽  
Foot Care ◽  
Control Group Design ◽  
Patients With Diabetes

Diabetes mellitus dapat menyebabkan cukup banyak komplikasi seperti kelainan mata, kelainan ginjal, kelainan pembuluh darah dan kelainan pada kaki. Penderita diabetes mellitus yang mengalami komplikasi kronis perlu diberikan upaya preventif untuk mencegah komplikasi, salah satunya adalah kemampuan perawatan kaki. Penelitian ini dilakukan untuk menguji efektivitas supportive educative system dalam meningkatkan kemandirian perawatan kaki pada pasien dengan diabetes mellitus Tipe II di Puskesmas Permata Sukarame, Bandar Lampung. Penelitian ini menggunakan metode quasy eksperimen dengan desain pretest-posttest with control group dengan total masing-masing kelompok sebanyak 18 responden. Pengumpulan data dilakukan dengan menyebarkan kuesioner kepada responden yang memenuhi kriteria inklusi penelitian. Penelitian ini diuji menggunakan analisis univariat, bivariat dan uji T-test. Hasil penelitian menunjukkan bahwa terdapat perbedaan rata-rata dalam kemandirian perawatan kaki pada kelompok intervensi dan kelompok kontrol dengan p-value 0,000. Pendidikan dan praktik perawatan kaki harus diberikan sejak dini sebagai upaya pencegahan untuk komplikasi.   Kata kunci : Supportive educative system, kemandirian perawatan kaki   SUPPORTIVE EDUCATIVE SYSTEM IN IMPROVING INDEPENDENCE OF FOOT CARE IN PATIENTS WITH DIABETES MELLITUS TYPE II   ABSTRACT Diabetes mellitus can cause quite a lot of complications such as eye disorders, kidney disorders, vascular disorders and abnormalities in the legs. Patients with diabetes mellitus who have chronic complications need to be given a preventive effort to prevent complications, one of which is foot care ability. This research was conducted to examine the effectiveness of supportive educative systems in increasing the independence of foot care in patients with Type II diabetes mellitus in the Permata Sukarame Health Center Bandar Lampung Working Area. This study used a quasi-experimental method with pretest-posttest with control group design with a total of 18 respondents each. Data collection is done by distributing questionnaires to respondents who meet the research inclusion criteria. This study was tested using univariate, bivariate, T-Test analysis. The results showed that the mean differences in the independence of foot care in the intervention group and the control group in the Permata Sukarame Community Health Center work area with a p-value of 0,000. Education and practice of foot care should be given early as a preventative effort for complications.   Keywords: Supportive educative system, independence of foot care

PENGARUH PELATIHAN PENGENDALIAN VEKTOR DEMAM BERDARAH TERHADAP MAYA INDEX PADA SISWA SEKOLAH DASAR DI MAJALENGKA

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Wawan Kurniawan
Keyword(s):  
Vector Control ◽  
Dengue Fever ◽  
Dengue Hemorrhagic Fever ◽  
Intervention Group ◽  
Hemorrhagic Fever ◽  
Control Group ◽  
Control Group Design ◽  
Group Design ◽  
Quasi Experimental ◽  
Dengue Vector Control

ABSTRAK  Latar belakang: Demam Berdarah Dengue (DBD) disebabkan oleh virus Dengue dapat menyebabkan kematian. Pencegahan DBD yang dianggap paling tepat adalah Pemberantasan Sarang Nyamuk (PSN). Penelitian ini bertujuan untuk mengetahui pengaruh pelatihan pengendalian vektor Demam Berdarah pada siswa sekolah dasar terhadap Maya Index di Majalengka. Metode: Penelitian ini menggunakan desain quasi experiment (pretest-posttest control group design). Sebanyak 4 sekolah terpilih sebagai kelompok intervensi dan 4 sekolah lainnya sebagai kontrol. Subyek penelitian adalah siswa kelas IV-VI yang terdiri dari 171 siswa pada kelompok intervensi dan 163 pada kelompok kontrol. Instrumen yang digunakan adalah formulir pemantauan jentik berkala. Hasil: Jumlah rumah dengan kategori Maya Index tinggi berkurang dari 27,5% menjadi 9,4%. Terjadi penurunan angka BRI kategori tinggi pada kelompok intervensi dari 20,5% menjadi 1,8%. Pada kelompok kontrol tidak terjadi penurunan angka BRI kategori tinggi (22,1%), sebaliknya terjadi penurunan kategori rendah dari 34,4% menjadi 3,7%. Tidak terjadi penurunan angka HRI pada kelompok intervensi maupun kontrol. Kesimpulan: Pelatihan pengendalian vektor Demam Berdarah dapat menurunkan nilai BRI dan Maya Index, tetapi tidak berpengaruh terhadap nilai HRI. Tidak adanya perubahan nilai HRI menunjukkan bahwa kebersihan dan sanitasi lingkungan merupakan faktor yang berpengaruh terhadap probabilitas kejadian demam berdarah. Kata Kunci : Demam Berdarah, Maya Index, pelatihan, pengendalian vektor   ABSTRACT Background: Dengue Hemorrhagic Fever (DHF) caused by Dengue virus could cause death. The most appropriate prevention of Dengue is eradication of mosquito nests (PSN). This study aims to determine the effect of Dengue vector control training on elementary students towards Maya Index in Majalengka. Method: This study used quasi-experimental design (pretest-posttest control group design). A total of 4 schools were selected as intervention groups and 4 other schools as controls. The subjects were students in grades IV-VI consisting of 171 students in the intervention group and 163 in the control group. The instrument used was periodic larva monitoring form. Results: The number of houses with a high Maya Index category in the intervention group decreased from 27.5% to 9.4%. There was a decrease in the high BRI category in the intervention group from 20.5% to 1.8%. In the control group, there was no decrease in the high BRI category (22.1%), on the contrary, there was a decrease in the low category from 34.4% to 3.7%. There was no decrease in HRI rates both of intervention or control groups. Conclusion: Dengue Fever vector control training could decrease the value of BRI and Maya Index, but does not affect the value of HRI. The absence of changes in HRI  indicate that environmental hygiene and sanitation are factors that influence the probability of dengue fever occurrence. Keywords: Dengue Hemorrhagic Fever, Maya Index, training, vector control

scholarly journals Educational Intervention to Improve Citizen’s Healthcare Participation Perception in Rural Japanese Communities: A Pilot Study

2021 ◽  
Vol 18 (4) ◽  
pp. 1782
Author(s):  
Ryuichi Ohta ◽  
Yoshinori Ryu ◽  
Jun Kitayuguchi ◽  
Chiaki Sano ◽  
Karen D. Könings
Keyword(s):  
Rural Communities ◽  
Self Efficacy ◽  
Cognitive Theory ◽  
Health Management ◽  
Intervention Group ◽  
Educational Interventions ◽  
Medical Professionals ◽  
Control Group ◽  
Structured Interviews ◽  
Japanese Elderly

In this mixed-methods study, we hypothesized that social cognitive theory (SCT)-based educational interventions for healthcare participation can improve the self-efficacy of older rural citizens in participating in their health management without any difficulties. Quasi-experimental study before and after SCT-based educational interventions and semi-structured interviews were conducted. Participants were Japanese elderly (>65 years) from rural communities. Propensity score matching was performed to estimate the effectiveness of educational interventions on participants’ perception (intervention: n = 156; control: n = 121). Interview contents were transcribed verbatim and analyzed based on thematic analysis. The intervention group scored significantly higher than the control group for participation in planning and managing self-care. Interviews revealed three themes: ability to manage health conditions, relationship with medical professionals, and relationship among citizens. Participants reported difficulties in judging symptoms and communicating with medical professionals. Hierarchy and low motivation to participate in healthcare hindered collaboration. The findings suggest that SCT-based educational interventions can positively impact rural citizens’ self-efficacy in healthcare participation.

scholarly journals Assessing the impact of the European resilience curriculum in preschool, early and late primary school children

2021 ◽  
pp. 014303432110250
Author(s):  
Celeste Simões ◽  
Anabela C. Santos ◽  
Paula Lebre ◽  
João R. Daniel ◽  
Cátia Branquinho ◽  
...  
Keyword(s):  
Mental Health ◽  
Intervention Group ◽  
Well Being ◽  
Primary School Children ◽  
Control Group ◽  
Physical And Mental Health ◽  
Quasi Experimental ◽  
Mental Health Difficulties ◽  
Prosocial Behaviours ◽  
The Impact

Resilience is an individual’s ability to adapt successfully to and persevere during and after significant challenges. Resilience programmes based on a socioemotional learning approach have been associated with an increase in protextive factors (e.g., prosocial competencies), improvements in physical and mental health, and a decrease in internalised and externalised symptoms. The present study aimed to evaluate the impact of the RESCUR curriculum implemented in Portuguese schools on students’ academic, behavioural, and socioemotional outcomes, based on child and teacher reports. Participants included 1,084 children (53.2% male) aged 3-15 ( M = 7.24, SD = 2.31). A quasi-experimental study compared outcomes for an experimental intervention group (AIG) with a waiting list control group (WG). The results showed the RESCUR programme decreased mental health difficulties while increasing both prosocial behaviours and well-being. In addition, academic performance increased for those in preschool after implementation. Both teachers and children consistently reported positive behavioural changes in resilience-related competencies after implementing RESCUR. Our findings contribute to the recent research on the potential of RESCUR to address key socioemotional competencies and improve relevant protextive factors. Study limitations and future recommendations are addressed.

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