Prevalence of Perineal Tear Peripartum after Two Antepartum Perineal Massage Techniques: A Non-Randomised Controlled Trial

Perineal massage increases elasticity of myofascial perineal tissue and decreases the burning and perineal pain during labour, thus optimising child birth, although an application protocol has not been standardised yet. The objective of this study is to determine the efficiency of massage in perineal tear prevention and identification of possible differences in massage application. Total of 90 pregnant participants were divided into three groups: perineal massage and EPI-NO® device group, applied by an expert physiotherapist, self-massage group, where women were instructed to apply perineal massage in domestic household, and a control group, which received ordinary obstetric attention. Results: The results showed significant differences among the control group and the two perineal massage groups in perineal postpartum pain. Correlations in perineal postpartum pain, labour duration and the baby’s weight were not statistically significant. Lithotomy posture was significantly less prevalent in the massage group than in the other two; this variable is known to have a direct effect on episiotomy incidence and could act as a causal covariate of the different incidence of episiotomy in the groups. Perineal massage reduces postpartum perineal pain, prevalence and severity of perineal tear during delivery.

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A Randomised Controlled Trial to Evaluate Learning Effectiveness Using an Adaptive Serious Game to Teach SQL at Higher Education Level

Psychology, Pedagogy, and Assessment in Serious Games - Advances in Game-Based Learning ◽

10.4018/978-1-4666-4773-2.ch013 ◽

2013 ◽

pp. 270-291

Author(s):

Thomas Hainey ◽

Mario Soflano ◽

Thomas M. Connolly

Keyword(s):

Higher Education ◽

Randomised Controlled Trial ◽

Learning Style ◽

Computer Games ◽

Query Language ◽

Controlled Trial ◽

The Other ◽

Control Group ◽

Learning Effectiveness ◽

Randomised Controlled

The literature suggests that every learner has a particular Learning Style (LS) and it is beneficial for the teacher and the learning approach to adapt to and accommodate these differences. The traditional classroom fails to motivate some learners and to maintain their engagement level during learning, possibly because of lack of interactivity. Computer games on the other hand seem to be able to engage participants for prolonged periods of time and motivate them to replay the game repeatedly. Some educationalists consider games as a potential platform to support learning and the term Games-Based Learning (GBL) has been introduced into the curriculum to reflect this approach. While many GBL applications have been developed, there is still a lack of empirical evidence to support its validity. Furthermore, there are very few adaptive GBL applications developed and adaptive GBL frameworks proposed. Another issue with GBL is that games engage the learners differently compared to traditional teaching approaches or eLearning and learning styles may differ inside and outside of the game. For the purpose of this research, a game with three game modes was developed. The modes were 1) non-adaptivity mode, 2) a mode that customises the game according to the learner’s LS identified by a LS questionnaire, and 3) a mode with an in-game adaptive system based on a newly developed framework that can automatically adapt content according to the learner’s interactions with the game. GBL has been used to teach various disciplines; however, this research focuses on teaching Structured Query Language (SQL) at Higher Education (HE). A Randomised Controlled Trial (RCT) was conducted with 30 students for each of the above game modes and another 30 students in a control group who learned SQL using a traditional paper-based approach. The results show that the game developed, regardless of mode, produced better learning outcomes than those who learned from a textbook. Particularly for adaptive GBL, learning effectiveness was identified to be higher while the learning duration was shorter compared to the other modes of the game.

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A Randomised Controlled Trial to Evaluate Learning Effectiveness Using an Adaptive Serious Game to Teach SQL at Higher Education Level

Gamification ◽

10.4018/978-1-4666-8200-9.ch068 ◽

2015 ◽

pp. 1346-1367

Author(s):

Thomas Hainey ◽

Mario Soflano ◽

Thomas M. Connolly

Keyword(s):

Higher Education ◽

Randomised Controlled Trial ◽

Learning Style ◽

Computer Games ◽

Query Language ◽

Controlled Trial ◽

The Other ◽

Control Group ◽

Learning Effectiveness ◽

Randomised Controlled

The literature suggests that every learner has a particular Learning Style (LS) and it is beneficial for the teacher and the learning approach to adapt to and accommodate these differences. The traditional classroom fails to motivate some learners and to maintain their engagement level during learning, possibly because of lack of interactivity. Computer games on the other hand seem to be able to engage participants for prolonged periods of time and motivate them to replay the game repeatedly. Some educationalists consider games as a potential platform to support learning and the term Games-Based Learning (GBL) has been introduced into the curriculum to reflect this approach. While many GBL applications have been developed, there is still a lack of empirical evidence to support its validity. Furthermore, there are very few adaptive GBL applications developed and adaptive GBL frameworks proposed. Another issue with GBL is that games engage the learners differently compared to traditional teaching approaches or eLearning and learning styles may differ inside and outside of the game. For the purpose of this research, a game with three game modes was developed. The modes were 1) non-adaptivity mode, 2) a mode that customises the game according to the learner's LS identified by a LS questionnaire, and 3) a mode with an in-game adaptive system based on a newly developed framework that can automatically adapt content according to the learner's interactions with the game. GBL has been used to teach various disciplines; however, this research focuses on teaching Structured Query Language (SQL) at Higher Education (HE). A Randomised Controlled Trial (RCT) was conducted with 30 students for each of the above game modes and another 30 students in a control group who learned SQL using a traditional paper-based approach. The results show that the game developed, regardless of mode, produced better learning outcomes than those who learned from a textbook. Particularly for adaptive GBL, learning effectiveness was identified to be higher while the learning duration was shorter compared to the other modes of the game.

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Effect of perineum massage with olive oil on perineum integrity and duration of second period of delivery

Journal of Human Sciences ◽

10.14687/jhs.v18i2.6029 ◽

2021 ◽

Vol 18 (2) ◽

pp. 131-142

Author(s):

Evrim Bayraktar ◽

Mürüvvet Başer

Keyword(s):

Olive Oil ◽

Intervention Group ◽

Control Group ◽

Perineal Tear ◽

Second Stage Of Labor ◽

Second Stage ◽

Massage Group ◽

And Control ◽

Perineal Massage ◽

Second Period

Background: Perineal trauma that may occur during labor may pose a critical risk both for mother’s health and her quality of life. Childbirth and puerperium are of the most important periods in women’s lives and can affect different aspects of their lives. Aims and objectives: To determine the effect of perineal massage in the second stage of labor with olive oil on perineal lacerations, episiotomy, and perineum tears in multiparous women. Design: A randomized controlled trial. Method: Among women who applied to Maternity Hospital in Turkey 350 pregnant women were assigned to massage group while other 350 were to control group. The participants were selected through convenience sampling, and randomly assigned to two groups: intervention and control groups. The intervention group received perineal massage with olive oil during second stage of labor. Subsequently, we analyzed perineal laceration, episiotomy, and perineal tear among the two groups. All of them were taught about postpartum perineal tear and its severity, and the researcher followed them up 4 hours, and 1 days after childbirth. The data were analyzed using SPSS version 18. We used descriptive statistics and analytical statistics, including t test, Chi-square test, One-Simple Kolmogorov Smirnov test. Findings: Frequency of episiotomy was 34.3% in the intervention group and 48.6% in the control group, and the difference was statistically significant (p<0.05) Tear appeared in 17.7% of the massage group while in 38.0% of the controls. Percentage of tear formation in the massage group significantly decreased (p<0.05) No statistically significant difference was found between the second period of the delivery of massage and control group Conclusion: Regarding the results of this study and those of other studies, perineal massage during the second stage of labor can reduce the need for episiotomy, and avoid perineal injuries, and perineal pain.

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Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol03-i07/02 ◽

2018 ◽

Vol 3 (07) ◽

Author(s):

Ms. Sonam Yangchen Bhutia ◽

Dr. Sushma Kumari Saini ◽

Dr. Manmeet Kaur ◽

Dr. Sandhya Ghai

Keyword(s):

School Children ◽

Home Visit ◽

Controlled Trial ◽

Family Members ◽

Sampling Technique ◽

Control Group ◽

Food Hygiene ◽

Parent Communication ◽

Post Test ◽

Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members. After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

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Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

Human Reproduction Open ◽

10.1093/hropen/hoab001 ◽

2021 ◽

Vol 2021 (1) ◽

Author(s):

S van Wessel ◽

T Hamerlynck ◽

V Schutyser ◽

C Tomassetti ◽

C Wyns ◽

...

Keyword(s):

Live Birth ◽

Financial Support ◽

Controlled Trial ◽

Reproductive Age ◽

Fertility Treatment ◽

Control Group ◽

Women Of Reproductive Age ◽

Operative Hysteroscopy ◽

Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

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Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-021-06002-5 ◽

2021 ◽

Author(s):

Ruth E. Ashton ◽

Jonathan J. Aning ◽

Garry A. Tew ◽

Wendy A Robson ◽

John M Saxton

Keyword(s):

Randomised Controlled Trial ◽

Radical Prostatectomy ◽

Muscular Strength ◽

Controlled Trial ◽

Control Group ◽

Robot Assisted ◽

Resistance Exercise Training ◽

Home Based ◽

Aerobic Exercise Capacity ◽

Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00886-0 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Kristina Traxler ◽

Franz Schinabeck ◽

Eva Baum ◽

Edith Klotz ◽

Barbara Seebacher

Keyword(s):

Randomised Controlled Trial ◽

Ankle Joint ◽

Manual Therapy ◽

Controlled Trial ◽

Daily Activities ◽

Control Group ◽

Chronic Stage ◽

Post Stroke ◽

Randomised Controlled ◽

Task Oriented

Abstract Background Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. Methods This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients’ skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. Discussion Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. Trial registration German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.

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Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

Thorax ◽

10.1136/thoraxjnl-2020-215755 ◽

2021 ◽

pp. thoraxjnl-2020-215755

Author(s):

Petr Waldauf ◽

Natália Hrušková ◽

Barbora Blahutova ◽

Jan Gojda ◽

Tomáš Urban ◽

...

Keyword(s):

Electrical Stimulation ◽

Randomised Controlled Trial ◽

Functional Electrical Stimulation ◽

Controlled Trial ◽

Cycle Ergometry ◽

Control Group ◽

Mechanically Ventilated ◽

Icu Discharge ◽

Randomised Controlled

PurposeFunctional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.MethodsWe enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.ResultsWe randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.ConclusionEarly delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration numberNCT02864745.

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