Video colposcopy improves adherence to follow-up compared to regular colposcopy: a randomized trial

Objective To assess and compare rates of adherence to follow-up in women undergoing video or regular colposcopy.Method Sixty patients with abnormal Pap smears were randomized to undergo video or regular colposcopy. All participants were given the same instructions and a follow-up appointment. If a patient did not keep her appointment and did not reschedule, this was considered a failure. Multivariate logistic regression was used for assessment of predictors of follow-up.Results The follow-up rate was significantly higher in the video colposcopy group compared to the regular colposcopy group (80 vs. 50%, p=0.014). After adjusting for results of previous and referral Pap smears, and previous treatment, multivariate analyses indicated that women undergoing video colposcopy were almost five times more likely to return for follow-up than women undergoing regular colposcopy (odds ratio=4.9, 95% confidence interval=[1.24, 19.39]).Conclusion Colposcopy clinics with patient population similar to ours may consider the use of video colposcope.     

The effect of hand reflexology on anxiety in patients undergoing coronary angiography: A single-blind randomized controlled trial

BackgroundThis study aimed to evaluate effects of hand reflexology on anxiety level in coronary angiography patients.Materials and methodsThis clinical trial recruited 80 eligible patients >6 months. The patients were randomly assigned to receive routine care plus either hand reflexology or a simple hand massage. Data were collected using the Spielberger State-Trait Anxiety Inventory. Both groups' anxiety levels were measured before (T0) and 30 min (T1) and 1 h after the intervention (T2).FindingsThe mean anxiety level in the intervention group decreased from 57.54 at baseline to 55.47 after the intervention (P = 0.0001). The values in the control group were 54.27 and 51.4, respectively. The two groups had statistically significant differences in the mean scores of anxiety at T0 and T1 (P = 0.003), T1 and T2, and T0 and T2 (P = 0.0001).ConclusionHand reflexology could effectively decrease anxiety in coronary angiography patients.     

The effect of music in gynaecological office procedures on pain,anxiety and satisfaction: a randomized controlled trial

Background

Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures.

Methods

A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients’ level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients’ level of pain after the procedure, anxiety and satisfaction of patient and doctor.

Results

No positive effect of music on patients’ perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups.

Conclusions

This study showed no positive effect of music on patients’ level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music.

Trial registration

Dutch Trial Register, NTR4924

     

Unsatisfactory colposcopy and the response to orally administered oestrogen: a randomized double blind placebo controlled trial

Summary. Thirty-six women with dyskaryotic cervical smears and unsatisfactory colposcopy were randomly allocated to receive either 30 μg ethinyl oestradiol or placebo daily by mouth for 10 days. Thirty-four women were available for review (17 women in each of the two groups), full colposcopic inspection of the transformation zone was possible in a significantly greater proportion of the oestrogen treated group (70% versus 23%, P <0.01). As most diagnostic conizations are currently performed on the basis of unsatisfactory colposcopy, the use of oestrogen medication followed by colposcopic reassessment should permit a reduction in the number of patients subject to operation.     

Unsatisfactory colposcopy and the response to orally administered oestrogen: a randomized double blind placebo controlled trial

Thirty-six women with dyskaryotic cervical smears and unsatisfactory colposcopy were randomly allocated to receive either 30 micrograms ethinyl oestradiol or placebo daily by mouth for 10 days. Thirty-four women were available for review (17 women in each of the two groups), full colposcopic inspection of the transformation zone was possible in a significantly greater proportion of the oestrogen treated group (70% versus 23%, P less than 0.01). As most diagnostic conizations are currently performed on the basis of unsatisfactory colposcopy, the use of oestrogen medication followed by colposcopic reassessment should permit a reduction in the number of patients subject to operation.     

The use of intrauterine lidocaine to minimize pain during hysterosalpingography: a randomized trial

OBJECTIVE: A hysterosalpingogram is an integral part of the evaluation of infertility but is often painful. Intrauterine anesthesia may help to alleviate the discomfort associated with this procedure. METHODS: We conducted a randomized, double-blinded, placebo-controlled trial of intrauterine lidocaine in women undergoing hysterosalpingography (HSG). All women were instructed to take a nonsteroidal analgesic before the hysterosalpingogram. Patients received 3 mL of buffered 2% lidocaine solution or 0.9% normal saline instilled into the uterus before HSG. The primary outcome was the degree of pain experienced documented via 10-cm visual analogue pain scales. Systematic assessments of discomfort were also collected by the attending physician, radiology technician, and radiology physician. RESULTS: Sixty-four patients were randomly assigned to placebo and 63 women were randomly assigned to the lidocaine group. There were no differences in mean age, race, parity, or history of dysmenorrhea or chronic pelvic pain. There were no differences in the pain scores at baseline, during, or after the study procedure between the 2 groups. Peak pain scale scores associated with the procedure were 5.3 +/- 0.4 in both the placebo and study groups. In addition, assessments of patient discomfort revealed no significant differences between the 2 groups. CONCLUSION: We found no difference in pain between the intrauterine-lidocaine and placebo groups. Intrauterine lidocaine does not appear to be effective in decreasing pain in women undergoing HSG. LEVEL OF EVIDENCE: I     

A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial

OBJECTIVE: To estimate the efficacy of a simple clinical maneuver that facilitates removal of residual abdominal carbon dioxide (CO2) after laparoscopic surgery to reduce shoulder pain. METHODS: A total of 116 female outpatients who were scheduled for elective gynecologic laparoscopic surgery were randomly allocated to either the current standard (control group) or to additional efforts to remove residual CO2 at the end of surgery. In the control group, CO2 was removed by passive deflation of the abdominal cavity through the cannula. In the intervention group, CO2 was removed by means of Trendelenburg position (30 degrees) and a pulmonary recruitment maneuver consisting of five manual inflations of the lung. Postoperative shoulder pain was assessed before discharge and 12, 24, 36, and 48 hours later using a visual analog scale (VAS, 0-100). In addition, positional characteristics of the shoulder pain and incidence of postdischarge nausea and vomiting were recorded until 48 hours after discharge. RESULTS: Pain scores in the control and intervention groups were 30.3+/-4.5 compared with 15.6+/-3.0, 25.7+/-4.7 compared with 10.8+/-2.4, and 21.7+/-4.3 compared with 9.1+/-2.5 at 12, 24 and 36 hours after discharge, respectively (all P<.05). The intervention reduced positional pain from 63% to 31% (P<.05) and the incidence of postoperative nausea and vomiting from 56.5% to 20.4% (P<.001). CONCLUSION: This simple clinical maneuver at the end of surgery reduced shoulder pain as well as postoperative nausea and vomiting after laparoscopic surgery by more than half. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, ClinicalTrials.gov, NCT00575237 LEVEL OF EVIDENCE: I.     

Role of misoprostol in overcoming an unsatisfactory colposcopy: a randomized double-blind placebo-controlled clinical trial

OBJECTIVE: To assess the effectiveness of vaginal misoprostol in overcoming an unsatisfactory colposcopy and to analyse the factors that might influence the response to misoprostol, i.e. age, menopausal status, duration of menopause and cervical characteristics. STUDY DESIGN: A randomized double-blind placebo-controlled clinical trial. METHODS: Forty patients with unsatisfactory colposcopy were recruited from the colposcopy clinic and were randomly allocated to receive either 400 microg misoprostol or similar-looking placebo tablets vaginally. Repeat colposcopy was performed after 6 h noting the side effects, if any. RESULTS: One patient was excluded from the misoprostol group because postdrug colposcopic examination could not be done due to a technical fault. Of the 19 patients in the misoprostol group, 15 (78.9%) had satisfactory examination compared to only 6 of the 20 (30%) patients in the placebo group. This effect of misoprostol was statistically significant (p = 0.004). Misoprostol in the present study averted 3 cone biopsies and 12 endocervical curettages. The side effects of misoprostol were comparable in both groups. The slit-like external os and the posterior cervical lip as the site of unsatisfactory colposcopy had better conversion rates compared to pinhole os (66.6 vs.81.2%) and anterior lip involvement (85.7 vs.100%). CONCLUSION: Four hundred micrograms of intravaginal misoprostol is an effective and safe method to convert an unsatisfactory colposcopy into a satisfactory one.     

A double-blind randomized controlled trial on the use of prophylactic antibiotics in patients undergoing elective caesarean section

Summary. In a double-blind randomized controlled study 232 patients undergoing elective lower segment caesarean section were randomly allocated to receive a pre-operative prophylactic dose of a combination of crystalline penicillin and chloramphenicol or a placebo. The two groups were comparable in terms of patient characteristics and operation variables. The group receiving antibiotics had significantly fewer febrile and infectious morbid events and thus spent fewer days in hospital than the group receiving the placebo.     

A double-blind randomized controlled trial on the use of prophylactic antibiotics in patients undergoing elective caesarean section

In a double-blind randomized controlled study 232 patients undergoing elective lower segment caesarean section were randomly allocated to receive a pre-operative prophylactic dose of a combination of crystalline penicillin and chloramphenicol or a placebo. The two groups were comparable in terms of patient characteristics and operation variables. The group receiving antibiotics had significantly fewer febrile and infectious morbid events and thus spent fewer days in hospital than the group receiving the placebo.     

Effects of prenatal music stimulation on state/trait anxiety in full-term pregnancy and its influence on childbirth: a randomized controlled trial

Background: Many researchers have pointed out the strong relationship between maternal psychological well-being and fetal welfare during pregnancy. The impact of music interventions during pregnancy should be examined in depth, as they could have an impact on stress reduction, not only during pregnancy but also during the course of delivery, and furthermore induce fetal awareness.

Objective: This study aimed to investigate the effect of music on maternal anxiety, before and after a non-stress test (NST), and the effect of music on the birthing process.

Material and method: The four hundred and nine pregnant women coming for routine prenatal care were randomized in the third trimester to receive either music (n?=?204) or no music (n?=?205) stimulation during an NST. The primary outcome was considered as the maternal state anxiety score before and after the NST, and the secondary outcome was the birthing process.

Results: Before their NST, full-term pregnant women who had received music intervention were found to have a similar state-trait anxiety score to those from the control group, with 38.10?±?8.8 and 38.08?±?8.2, respectively (p?=?.97). After the NST, the mean state-trait anxiety score of each group was recorded, with results of 30.58?±?13.2 for those with music intervention, and 43.11?±?15.0 for those without music intervention (p?p?p?p?p?Conclusions: Prenatal music intervention could be a useful and effective tool to reduce anxiety in full-term pregnant women during an NST and improve the delivery process by reducing the first stage of labor in nulliparous women.     

Variables influencing anxiety of patients with abnormal cervical smears referred for colposcopy

The state anxiety scores of women with abnormal cervical smears referred for colposcopy were investigated to identify causes of anxiety, factors influencing anxiety and emotions involved with anxiety, in order to define strategies to reduce this anxiety. Forty-seven women were interviewed and completed a questionnaire and the Spielberger State and Trait Anxiety Inventory (STAI): 22 women prior to their intake consultation at the colposcopy clinic of the University Medical Center St Radboud, Nijmegen, and 25 women during their second visit before the actual colposcopy. The mean State anxiety score was 48.2, without significant differences between the intake and colposcopy consultation. The majority experienced anxiety because of a fear of cancer and/or the colposcopy. The mean State anxiety score was significantly higher in women who considered the level of information provided by the gynecologist/family practitioner insufficient, who experienced a long waiting time, who did not have a partner, and who experienced additional emotions like anger and sadness. In conclusion, patients referred for colposcopy after an abnormal cervical smear result have high levels of anxiety. High levels of anxiety may be reduced by uniform and explicit information about cervical smear results and colposcopy, by reduction of clinic waiting times, by stimulating social support, and by attention to emotions like anger and sadness.     

Metformin treatment in patients with polycystic ovary syndrome undergoing in vitro fertilization: a prospective randomized trial

In the present study, we investigated the impact of metformin therapy on in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes in patients with polycystic ovary syndrome (PCOS). Metformin does not lead to any improvement in IVF/ICSI outcomes among patients with PCOS.     

Music for anxiety reduction in patients undergoing cardiac catheterization: A systematic review and meta-analysis of randomized controlled trials

BackgroundMedical diagnostic procedures, such as cardiac catheterization, can cause significant patient anxiety. Patient anxiety can have negative implications for compliance with healthcare visits, medical tests, and treatments. Music interventions may have a role in reducing anxiety related to cardiac catheterization procedures.ObjectiveTo perform a comprehensive systematic review and meta-analysis evaluating whether musical interventions reduce anxiety in patients undergoing cardiac catheterization.Data sourcesMEDLINE, EMBASE, CENTRAL, AMED, and PsychINFO from inception to May 2015. Reference lists of included articles were further hand searched for additional eligible studies.Study selectionRandomized controlled trials evaluating the effectiveness of music interventions for anxiety reduction in patients undergoing cardiac catheterization.Data extraction and synthesisData on trial design, baseline characteristics and outcomes was extracted using a data extraction table. Study quality and risk of bias were assessed using the JADAD scale.Main outcomes and measuresThe main outcome was the effectiveness of music interventions in reducing anxiety in this patient population. Meta-analysis was pursued using data from studies that had used the Spielberger state anxiety inventory (STAI-S) to measure anxiety reduction. Other outcomes qualitatively reported include the use of anxiolytic medications and effect on physiological parameters such as blood pressure and heart rate.ResultsA total of 15 studies were found to be eligible for inclusion (14 published trials and one conference abstract) in this review. Two-thirds of these studies showed statistically significant reduction in measures of patient anxiety or well-being with musical interventions. Meta-analysis included six studies (n = 695) and showed statistically significant reduction in mean STAI-S scores with music (−3.95 points; 95% confidence −5.53 and −2.37; p value less than 0.005).Conclusion and relevanceIn conclusion, music is a safe and easily administered intervention that can be used for anxiety reduction among patients undergoing cardiac catheterization. Further research is needed to better evaluate the clinical implications associated with the anxiolytic effects of music interventions during cardiac catheterization.     

A randomized controlled trial of prophylactic maneuvers to reduce head-to-body delivery time in patients at risk for shoulder dystocia

OBJECTIVE: To assess whether prophylactic use of the McRoberts maneuver and suprapubic pressure decreased the head-to-body time, as a proxy for shoulder dystocia, in at-risk patients. METHODS: Patients with estimated fetal weights over 3800 g were randomized to undergo the McRoberts maneuver and suprapubic pressure before delivery of the fetal head (prophylactic maneuvers) or to undergo maneuvers only after delivery of the head, if necessary (controls). A total of 185 patients were enrolled in the study. After exclusions (eg, abdominal delivery), there were 128 evaluable vaginal deliveries. The study had the power to detect a 30% difference in head-to-body time between groups. RESULTS: Head-to-body delivery times did not differ between the prophylactic and control patients (24 +/- 18 seconds versus 27 +/- 20 seconds, P =.38). In addition, the two groups did not differ in rates of admission of the infant to the special care nursery or in birth injuries. There was a significant increase in the risk of delivering by cesarean for patients randomized to the use of prophylactic maneuvers. CONCLUSION: This study does not support the hypothesis that prophylactic use of the McRoberts maneuver and suprapubic pressure speeds delivery in a population of patients at increased risk for shoulder dystocia.