Parents and procedures: a randomized controlled trial

INTRODUCTION: Previous work has shown that parents prefer to be present when their children undergo common invasive procedures, although physicians are ambivalent about parental presence. PURPOSE: To determine the effect of a parent-focused intervention on the pain and performance of the procedure, anxiety of parents and clinicians, and parental satisfaction with care. POPULATION: Children younger than 3 years old undergoing venipuncture, intravenous cannulation, or uretheral catheterization. SETTING: Pediatric emergency department of Boston City Hospital. DESIGN: Randomized controlled trial with three groups; parents present and given instructions on how to help their children; parents present, but no instructions given; and parents not present. INTERVENTION: The parents were instructed to touch, talk to, and maintain eye contact during the procedure. RESULTS: A total of 431 parents was randomized to the intervention (N = 153), present (N = 147), and not present (N = 131) groups. The groups were equivalent with respect to measured sociodemographic variables and parents' previous experience in the pediatric emergency department. No differences emerged with respect to pain (3-point scale measured by parent and clinician, and analysis of cry); performance of the procedure (number of attempts, completion of procedure by first clinician, time); clinician anxiety; or parental satisfaction with care. Parents who were present were more likely to rate the pain of the children as extreme/severe (52%) in comparison to clinicians (15%, kappa .07, poor agreement) and were significantly less anxious than parents who were not present. CONCLUSION: Overall, the intervention was not effective in reducing the pain of routine procedures. Parental presence did not negatively affect performance of the procedure or increase clinician anxiety. Parents who were present were less anxious than those who were not present. CLINICAL IMPLICATION: In general, parents have indicated that they want to be present when their children undergo procedures. The results of this study challenge the traditional belief that parental presence negatively affects our ability to successfully complete procedures. We should encourage parents who want to be present to stay during procedures.     

A randomized controlled trial of hypnosis for burn wound care.

Purpose/Objective: There have been few randomized controlled studies on the effectiveness of clinical hypnotic analgesia. The authors' goal was to improve on previous methodologies and gain a better understanding of the effects of hypnosis on different components of pain in a clinical setting. Research Method/Design: This study used a randomized controlled design in which the nurses and data collectors were unaware of treatment condition to compare hypnotic analgesia with an attention-only placebo for burn pain during wound debridements. Data were analyzed on a total of 46 adult participants. Results: The authors found that the group receiving hypnosis had a significant drop in pain compared with the control group when measured by the McGill Pain Questionnaire but not when measured by other pain rating scales. Conclusion: The McGill Pain Questionnaire total score reflects multiple pain components, such as its affective component and various qualitative components, and is not merely a measure of pain intensity. Thus, the findings suggest that hypnosis affects multiple pain domains and that measures that assess these multiple domains may be more sensitive to the effects of hypnotic analgesia treatments. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized clinical trial of two surgical techniques for cesarean section

The Joel-Cohen incision followed by nonclosure of pelvic and parietal peritoneum has been advocated as an alternative method to the Pfannenstiel incision with peritonealization at cesarean section. A randomized trial was designed to compare intra- and postoperative morbidity between the two techniques. Women to undergo a cesarean section were randomly allocated to have either the Joel-Cohen incision with the parietal and pelvic peritoneum left open (group 1) or to have the Pfannenstiel incision with both peritoneal layers sutured (group 2). The myometrium was closed with 1-0 polyglactin 910 suture using a continuous single-layer nonlocking technique. Patients in group 2 had the peritoneum approximated with 2-0 polyglactin 910 suture. The fascia was sutured with continuous 1-0 polyglactin 910 suture in all cases. Opening time was defined as the interval from skin incision to the opening of the uterine cavity. Febrile morbidity was defined as a temperature > or =38 degrees C on two occasions 4 hours (hr) apart excluding the first postoperative day. Endometritis was defined as postpartum temperature > or =38 degrees C on two occasions 4 hr apart, with uterine tenderness and/or foul-smelling lochia. One hundred forty-nine and 150 patients were allocated to group 1 and to group 2, respectively. A shorter median (range) opening time [4 min (2-21) vs. 6 min (2-19), respectively, p < 0.01] and a shorter median (range) operative time [30 min (10-65) vs. 40 min (20-110), respectively, p < 0.01] were observed in group 1. No difference was found in terms of intraoperative complications, proportion of patients who required transfusion, endometritis, sepsis, febrile morbidity, and urinary tract infections. A higher rate of wound infections was found in group 2 than in group 1 [14 of 150 (9.3%) vs. 2 of 149 (1.3%), respectively, p < 0.01]. The Joel-Cohen incision without peritonealization resulted in a shorter opening and total operative time than the Pfannenstiel laparotomy with peritonealization. This was accomplished with a reduction of wound infections.     

Preventing perinatal depression in low-income home visiting clients: A randomized controlled trial.

Objective: To assess the efficacy of a 6-week cognitive-behavioral intervention in preventing the onset of perinatal depression and reducing depressive symptoms among low-income women in home visitation programs. Method: Sixty-one women who were pregnant or who had a child less than 6 months of age and who were assessed as at risk for perinatal depression were randomized to a 6-week, group-based cognitive-behavioral intervention or usual home visiting services. Study participants were predominately African American, unmarried, and unemployed. Intervention sessions were led by a licensed clinical social worker or clinical psychologist. Home visitors provided 1-on-1 reinforcement of key intervention messages between group sessions. Depressive symptoms were measured with the Beck Depression Inventory–II (Beck, Steer, & Brown, 1996), and major depressive episodes were measured with the Maternal Mood Screener (MMS; Le & Mu?oz, 1998). Outcomes were assessed at baseline and at 1 week and 3 months postintervention. Results: Repeated measures analysis of variance indicated that there was a significant Time × Condition interaction, F(2, 112) = 4.1, p = .02. At 3 months postintervention, 9 of 27 (33%) women receiving usual care reported levels of depressive symptoms that met clinical cutoff for depression on the MMS compared with 3 of 32 (9%) women in the intervention condition, χ2(1, N = 59) = 5.18, p     

A randomized controlled trial of fluoxetine and cognitive behavioral therapy for bulimia nervosa: short-term outcome

This study compared and combined fluoxetine and individual cognitive behavioral therapy in the treatment of bulimia nervosa. Participants were 76 women who sought treatment at the Eating Disorders Program of the Toronto Hospital and who met DSM-III-R criteria for bulimia nervosa. Subjects were randomly assigned to receive fluoxetine alone, cognitive behavior therapy alone, or the two in combination and were treated over 16 weeks. Short-term outcome revealed that all three treatment conditions were associated with clinical improvement across a wide range of parameters. The combination of pharmacotherapy and psychotherapy was superior to pharmacotherapy alone on specific parameters and there was no statistically significant advantage to the combination over psychotherapy alone. Limitations to the study include the absence of a placebo pill group and a waiting list control group as well as a substantial dropout rate across all three treatment conditions.     

Abstinence or controlled drinking goals for problem drinkers: A randomized clinical trial.

24 adult problem drinkers were assigned to brief behavioral treatment with either an abstinence (AB) or a controlled drinking (CD) goal. Self-report and collateral report data reflect significant overall reduction in alcohol consumption and projected blood alcohol peaks at 3-mo and at 3.5-yr follow-up intervals. AB and CD Ss did not differ significantly from each other on outcome variables at any point before or after treatment. At 3.5 yrs, 4 Ss had been abstinent for at least 12 mo, 3 had been moderate and asymptomatic drinkers for at least 12 mo, 5 were improved but still somewhat impaired, 8 were unimproved, 3 refused to be interviewed, and 1 could not be located. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Multicenter randomized clinical trial of home uterine activity monitoring: pregnancy outcomes for all women randomized

OBJECTIVE: Our purpose was to evaluate the impact of home uterine activity monitoring on pregnancy outcomes among women at high risk for preterm labor and delivery. STUDY DESIGN: Women at high risk for preterm labor at three centers were randomly assigned to receive high-risk prenatal care alone (not monitored) or to receive the same care with twice-daily home uterine activity monitoring without increased nursing support (monitored). There were 339 women with singleton gestations randomized with caregivers blinded to group assignment. The two groups were medically and demographically similar at entry into the study. RESULTS: Women in the monitored group had prolonged pregnancy survival (p = 0.02) and were less likely to experience a preterm delivery (relative risk 0.59; p = 0.04). Infants born to monitored women with singleton gestations were less likely to be of low birth weight (< 2500 gm; relative risk 0.47, p = 0.003), and were less likely to be admitted to a neonatal intensive care unit (relative risk 0.5, p = 0.01). CONCLUSION: These data show, among women with singleton gestations at high risk for preterm delivery, that the use of home uterine activity monitoring alone, without additional intensive nursing care, results in improved pregnancy outcomes, including prolonged gestation, decreased risk for preterm delivery, larger-birth-weight infants, and a decreased need for neonatal intensive care.     

Octreotide: effective treatment for hyperparathyroidism? A prospective, randomized, controlled clinical trial

Although clinical and electrophysiological evidence indicates that the amygdaloid body plays an important role in the pathogenesis of temporal lobe epilepsy, there are very few detailed data on histopathological changes in this nucleus in epilepsy patients. In the present study we have examined the lateral nucleus of the amygdaloid body in 70 surgical specimens from patients with temporal lobe epilepsy and in 10 control specimens with respect to neuronal density and gliosis. The results were compared to the neuronal loss in the hippocampal formation. Our goal was to examine the pathological alterations of the amygdaloid body and their correlation with other morphological changes in temporal lobe epilepsy. In epilepsy patients with Ammon's horn sclerosis or focal lesions of the temporal lobe, the neuronal density of the lateral amygdaloid nucleus was significantly decreased as compared to normal controls (P < 0.001). Overall, the mean volumetric density in epilepsy patients was reduced to 59% of that in normal individuals. There was no correlation between the neuronal density in the lateral amygdaloid nucleus and that in the different segments of the hippocampal formation or to the age at onset or the duration of epilepsy. The neuronal loss of the amygdaloid nucleus correlated well with the presence of fibrillary gliosis. Our findings demonstrate that the amygdaloid body is severely altered in most patients with temporal lobe epilepsy and that these changes are independent of those in the hippocampus. The presence of neuronal loss and gliosis in the amygdaloid nucleus of patients with focal lesions but no Ammon's horn sclerosis is compatible with an involvement of the amygdala in secondary epileptogenesis.     

A randomized controlled trial of exercise therapy for dizziness and vertigo in primary care

BACKGROUND: 'Vestibular rehabilitation' (VR) is an increasingly popular treatment option for patients with persistent dizziness. Previous clinical trials have only evaluated the effects of specialist therapy programmes in small, selective, or uncontrolled patient samples. AIM: To determine the benefits of VR compared with standard medical care, using a brief intervention for dizzy patients in primary care. METHOD: Adults consulting their general practitioner (GP) with dizziness or vertigo were randomly assigned to treatment or control groups. Patients in both groups received the same evaluation at baseline, six-week follow-up, and six-month follow-up, comprising examination of nystagmus, postural control, and movement-provoked dizziness, and a questionnaire assessment of subjective status, symptoms, handicap, anxiety, and depression. At baseline and six weeks later, the treatment group also received an individualized 30-minute therapy session, in which they were taught head, eye, and body exercises designed to promote vestibular compensation and enhance skill and confidence in balance. RESULTS: The treatment group (n = 67) improved on all measures, whereas the control group (n = 76) showed no improvement, resulting in a significant difference between the two groups on physical indices of balance and subjective indices of symptoms and distress. Odds ratios for improvement in treated patients relative to untreated patients were 3.1:1 at six weeks (95% CI = 1.4-6.8) and 3.8:1 at six months (95% CI = 1.6-8.7). CONCLUSION: VR is a simple, inexpensive, and beneficial treatment, and may be an appropriate first stage of management for many dizzy patients in primary care.     

Enhancing home-based child care quality through video-feedback intervention: A randomized controlled trial.

In the present randomized controlled trial, the effectiveness of video-feedback intervention to promote positive parenting–child care (VIPP-CC) was tested in home-based child care. Forty-eight caregivers were randomly assigned either to the intervention group or to the control group. Global child care quality improved in the intervention group but not in the control group. The program did not change observed caregiver sensitivity. After the intervention however, caregivers in the intervention group reported a more positive attitude toward sensitive caregiving than caregivers in the control group. The study shows that the family-based intervention can be applied with some minor modifications in a professional group setting as well. The brief VIPP-CC program is an important tool for enhancing quality of home-based child care. (PsycINFO Database Record (c) 2011 APA, all rights reserved)     

A randomized controlled clinical trial of increased dietary iron in breast-fed infants

Six-month-old breast-fed infants were randomly allocated to a high iron (8.2 +/- 2.9 mg/day, n = 36) weaning diet or a control group (5.2 +/- 3.4 mg/day, n = 26). We could detect no effect of increased iron intake from weaning foods on iron status of these iron-sufficient infants at 12 months.     

Re: A randomized controlled trial of Intravenous clodronate

Pancoast's syndrome arises from neoplasms in 95% of cases but infection is a rare cause. We describe a patient with Pancoast's tumor secondary to tuberculosis. Pain caused by plexopathy and lack of diagnosis by noninvasive means led to the need for open biopsy.     

Predicting outcome in computerized cognitive behavioral therapy for depression in primary care: A randomized trial.

Objective: To explore pretreatment and short-term improvement variables as potential moderators and predictors of 12-month follow-up outcome of unsupported online computerized cognitive behavioral therapy (CCBT), usual care, and CCBT combined with usual care for depression. Method: Three hundred and three depressed patients were randomly allocated to (a) unsupported online CCBT, (b) treatment as usual (TAU), or (c) CCBT and TAU combined (CCBT&TAU). Potential predictors and moderators were demographic, clinical, cognitive, and short-term improvement variables. Outcomes were the Beck Depression Inventory–II score at 12 months of follow-up and reliable change. Results: Those with higher levels of extreme (positive) responding had a better outcome in CCBT compared with TAU, whereas those having a parental psychiatric history or a major depressive disorder diagnosis had a better outcome in CCBT&TAU compared with TAU. Predictors regardless of treatment type included current employment, low pretreatment illness severity, and short-term improvement on clinical variables. Conclusions: Optimistic patients, holding approach-oriented coping strategies, might benefit most from CCBT, whereas CCBT&TAU might be the most suitable option for those with more severe vulnerability characteristics. Those with the least impairment improve the most, regardless of treatment type. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effectiveness of an ambulatory care clinical pharmacist: a controlled trial

Medical therapy for duodenal or gastric ulcer disease has traditionally involved gastric acid antisecretory therapy for 4 to 8 weeks to promote initial healing and indefinitely to prevent recurrences of ulcer. The discovery of Helicobacter pylori in most patients with peptic ulcer disease has led to a change in this approach. Therapy designed to eradicate H pylori may facilitate ulcer healing with acid antisecretory agents and, more important, may greatly reduce the incidence of ulcer recurrence, obviating the need for maintenance antisecretory therapy. Regimens designed to eradicate H pylori are difficult to comply with, however, and are associated with adverse effects in some patients. In this article we review the diagnosis and treatment of H pylori infection in patients with peptic ulcer disease and make recommendations regarding the use of conventional ulcer therapies and therapies designed to eradicate H pylori.     

A randomized controlled trial of early physiotherapy for high-risk infants

The potential therapeutic applications of encapsulated cells are enormous. In the US alone, it has been estimated that nearly half-a-trillion dollars are spent each year to care for patients who suffer tissue loss or dysfunction. Over 6 million patients suffer from neurodegenerative disorders such as Alzheimer's disease and Parkinson's disease, over 14 million patients suffer from diabetes, and millions more from liver failure, hemophilia, and other diseases caused by the loss of specific vital cellular functions. It appears likely that by the end of the decade clinical trials of encapsulated cells to treat many of these diseases will become a reality. The Food and Drug Administration has already authorized studies to evaluate the safety and biological activity of several types of systems. A number of issues will have to be addressed, including the sourcing of raw materials, the design and building of manufacturing facilities, the scale-up and optimization process, storage and distribution of the product, and quality control.     

Computerized behavior therapy for opioid-dependent outpatients: A randomized controlled trial.

The authors evaluated the efficacy of an interactive, computer-based behavioral therapy intervention, grounded in the community reinforcement approach (CRA) plus voucher-based contingency management model of behavior therapy. Our randomized, controlled trial was conducted at a university-based research clinic. Participants comprised 135 volunteer adult outpatients who met DSM-IV criteria for opioid dependence. All participants received maintenance treatment with buprenorphine and were randomly assigned to one of three treatments: (a) therapist-delivered CRA treatment with vouchers, (b) computer-assisted CRA treatment with vouchers, or (c) standard treatment. The therapist-delivered and computer-assisted CRA plus vouchers interventions produced comparable weeks of continuous opioid and cocaine abstinence (M = 7.98 and 7.78, respectively) and significantly greater weeks of abstinence than the standard intervention (M = 4.69; p     

Brief cognitive therapy for panic disorder: A randomized controlled trial.

Cognitive therapy (CT) is a specific and highly effective treatment for panic disorder (PD). Treatment normally involves 12–15 1-hr sessions. In an attempt to produce a more cost-effective version, a briefer treatment that made extensive use of between-sessions patient self-study modules was created. Forty-three PD patients were randomly allocated to full CT (FCT), brief CT (BCT), or a 3-month wait list. FCT and BCT were superior to wait list on all measures, and the gains obtained in treatment were maintained at 12-month follow-up. There were no significant differences between FCT and BCT. Both treatments had large (approximately 3.0) and essentially identical effect sizes. BCT required 6.5 hr of therapist time, including booster sessions. Patients' initial expectation of therapy success was negatively correlated with posttreatment panic-anxiety. Cognitive measures at the end of treatment predicted panic-anxiety at 12-month follow-up. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Treatment of deep and shallow intrabony defects. A multicenter randomized controlled clinical trial

This prospective multicenter intra-individual randomized controlled clinical trial was designed to compare the efficacy of guided tissue regeneration (GTR) with bioresorbable barrier membranes versus access flap surgery, in intrabony defects. 2 similar defects were selected in each of 23 patients and randomly assigned to 1 of the 2 treatments. Surgery consisted of an identical procedure except for the omission of the barrier membrane in the flap control sites. At 1-year, probing pocket depth reductions were 4.3+/-2.3 mm in GTR treated sites and 3.0+/-1.5 mm in the flap control sites (p=0.02, paired t-test). Clinical attachment level (CAL) gains were 3.0+/-1.7 mm in the GTR sites and 1.6+/-1.8 mm in the control sites (p=0.009, paired t-test). A subset analysis, performed according to the initial depth of the intrabony component of the defects (INFRA), indicated that in shallow defects (INFRA < or =3 mm) treated with the access flap alone, CAL gains were 1+/-1.5 mm, while in deep ones (INFRA > or =4 mm) they were consistently greater (1.9+/-1.9 mm). The % CAL gains, calculated as the % of the baseline intrabony component depth, however, were almost identical in the 2 subpopulations (45.8+/-64.7% in shallow and 43.8+/-37.6% in deep defects). Similarly, in the GTR sites, linear CAL gains were greater in deep (3.7+/-1.7 mm) than in shallow defects (2.2+/-1.3 mm), but no differences were observed in terms of % CAL gains (76.7+/-27.7% and 75.8+/-45%, respectively). The frequency distribution of CAL changes expressed as %s of the baseline INFRA indicates that most of the sites treated with GTR (73% in shallow and 92% in deep defects) gained 50% or more CAL. Furthermore, many defects (64% of shallow and 33% of deep defects) reached 100% of CAL gain. The present study demonstrated that: (i) GTR with bioresorbable barrier membranes resulted in a significant added benefit in comparison with access flap alone; (ii) the linear amounts of CAL gains were greater in deep than in shallow defects; (iii) CAL gains expressed as %s of the baseline depths of the intrabony component, were similar in shallow and deep defects; (iii) the regenerative procedure tested in the present study resulted in CAL gains equal to the depth of the intrabony component of the defect in some, but not in most of the instances.     

A randomized controlled trial of brief interventions for body dissatisfaction.

The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction induction procedure, which significantly decreased levels of weight and appearance satisfaction. Participants were then randomized, 20 to each of 5 groups: control, ruminative attention control, acceptance, distraction, and cognitive dissonance. With the exception of the control group, participants were briefly trained in their assigned technique and were asked to practice this over the next 5 min while repeated measures of weight and appearance satisfaction were recorded. Acceptance, cognitive dissonance, and distraction were superior to both control conditions in increasing weight satisfaction and were superior to a control condition in improving appearance satisfaction. Only acceptance was superior in improving appearance satisfaction compared to a ruminative attention control. The evidence suggests that acceptance is a promising approach to investigate further with respect to its efficacy for reducing body dissatisfaction. (PsycINFO Database Record (c) 2010 APA, all rights reserved)