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result(s) for
"Lacerations - psychology"
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Anxiolysis for laceration repair in children: study protocol for an open-label multicenter adaptive trial (ALICE)
by
Gravel, Jocelyn
,
Tran, Nam Anh
,
Sabhaney, Vikram
in
Adaptive Clinical Trials as Topic
,
Administration, Intranasal
,
Anesthesia
2025
Lacerations are the most common traumatic reason for children to visit an emergency department (ED), accounting for almost half of all procedures performed. Children experience considerable distress during laceration repair, despite routine application of local anesthetic. Pharmacologic anxiolysis may mitigate the negative practice of forcefully restraining a child, however, evidence for the most effective agent is lacking. We aim to determine the most effective anxiolytic agent for laceration repair in children.
This is a multicentre, phase III, three-arm, adaptive, randomized, open-label, trial. We will include children 2-12 years with a single laceration requiring suture repair in the ED. Participants will be randomized to receive intranasal dexmedetomidine (IND) 3 mcg/kg, intranasal midazolam (INM) 0.4 mg/kg, or inhaled 50% nitrous oxide (N2O). The primary outcome is the weighted mean anxiolysis score using the Observational Scale of Behavioral Distress - Revised (OSBD-R) from initial positioning to tying of the last suture. Secondary outcomes include need for additional anxiolytic, need for physical restraint, adverse events (AEs), and delayed maladaptive behaviors. The primary analysis will be conducted by intention-to-treat. Results will report posterior means, standard deviations (SDs), and 95% high density posterior credible intervals for Total Distress Score on the OSBD-R. We will rank interventions based on the probability that an intervention is superior (Pbest) and the Surface Area Under the Cumulative Ranking Curve (SUCRA) to indicate relative anxiolytic efficacy. The mean difference in Total Distress Score and secondary outcomes will be estimated using Bayesian models.
Ethics approval will be obtained from institutional review boards of the participating sites. Informed consent will be obtained from guardians of all participants in addition to assent from all participants. Study data will be submitted for publication.
Clinicaltrials.gov NCT05383495.
Journal Article
Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE)
by
Jiang, Arlene
,
Arthur-Hayward, Vinolia
,
Heath, Anna
in
Adaptive Clinical Trials as Topic
,
Administration, Inhalation
,
Administration, Intranasal
2025
Background
Laceration repairs are a common, yet distressing procedure in children. While a range of strategies is used to treat this distress, there is currently no standard of care. The Anxiolysis for Laceration Repair in Children (ALICE) trial aims to identify the most effective pharmacological agent to manage laceration repair-associated distress. This paper outlines the statistical analysis plan for the ALICE trial.
The ALICE trial is a phase III, Bayesian, open-label trial that will identify the optimal agent for reducing distress among intranasal dexmedetomidine (IND), intranasal midazolam (INM), and inhaled nitrous oxide (N
2
O). The primary outcome, distress, will be measured by the Observational Scale of Behavioural Distress – Revised (OSBD-R). Scores from the OSBD-R will be analyzed using a Bayesian mixed effects model with data-driven prior distributions. Samples from the model’s posterior distributions will be used to calculate the probability of being best statistic (P
best
), which will effectively rank the interventions. The trial will also evaluate delayed maladaptive behaviours, need for additional physical restraint, adverse events, and need for additional sedation as secondary outcomes. Furthermore, the trial will determine the costs associated with achieving adequate sedation in each treatment arm.
Discussion
This statistical analysis plan specifies the outcomes and analyses for the ALICE trial. The ALICE trial will provide evidence for the most effective agent for reducing distress in children receiving laceration repairs.
Trial registration
ClinicalTrials.gov
NCT05383495
. Registered on May 16, 2022.
Journal Article
Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a nested qualitative study
by
Waterfield, J
,
Dudley, L
,
Kettle, C
in
Activities of Daily Living
,
Adult
,
Body Image - psychology
2017
ObjectiveTo explore women's lived experiences of a dehisced perineal wound following childbirth and how they felt participating in a pilot and feasibility randomised controlled trial (RCT).DesignA nested qualitative study using semistructured interviews, underpinned by descriptive phenomenology.Participants and settingA purposive sample of six women at 6–9 months postnatal who participated in the RCT were interviewed in their own homes.ResultsFollowing Giorgi's analytical framework the verbatim transcripts were analysed for key themes. Women's lived experiences revealed 4 emerging themes: (1) Physical impact, with sub-themes focusing upon avoiding infection, perineal pain and the impact of the wound dehiscence upon daily activities; (2) Psychosocial impact, with sub-themes of denial, sense of failure or self-blame, fear, isolation and altered body image; (3) Sexual impact; and (4) Satisfaction with wound healing. A fifth theme ‘participating in the RCT’ was ‘a priori’ with sub-themes centred upon understanding the randomisation process, completing the trial questionnaires, attending for hospital appointments and acceptability of the treatment options.ConclusionsTo the best of our knowledge, this is the first qualitative study to grant women the opportunity to voice their personal experiences of a dehisced perineal wound and their views on the management offered. The powerful testimonies presented disclose the extent of morbidity experienced while also revealing a strong preference for a treatment option.Trial registration numberISRCTN05754020; results.
Journal Article
Women’s experiences of wound dehiscence of a second-degree perineal tear and choice of treatment in Denmark: a qualitative interview study
by
Hegaard, Hanne Kristine
,
Moestrup, Lærke Vinberg
,
Høgh, Stinne
in
Adult
,
Body mass index
,
Childbirth & labor
2026
ObjectiveThis study aimed to describe women’s experiences of perineal wound dehiscence of a second-degree perineal tear and choice of resuturing or conservative treatment in the first two months after birth.DesignA qualitative descriptive study using individual semistructured interviews was conducted. Data were analysed using Braun and Clarke’s reflexive thematic analysis approach to explore women’s experiences and perspectives on dehisced perineal wounds of a second-degree perineal tear. Interviews were audio-recorded, transcribed verbatim and analysed concurrently with data collection.SettingPerineal clinics at the Department of Obstetrics and Gynaecology at two large University Hospitals in Copenhagen, Denmark.Participants17 women with dehisced perineal wound of a second-degree perineal tear.ResultsThree main themes were identified: (1) The unforeseen troubles: for the women with perineal wound dehiscence, the pain intensified immensely after the birth. It was an unexpected complication, and it affected the women negatively in various ways. (2) The emotional turmoil: it was a crisis for the women that their lower bodies were not intact. They were terrified, and they wondered if they had themselves to blame. Most women emphasised that choosing between resuturing or conservative treatment was a difficult and lonely decision. (3) Living with changes: regardless of treatment approach, women in both groups reported gradually managing their complicated healing and pain, but were concerned about their genitals and future births.ConclusionsThe findings indicate that wound dehiscence was related to a painful postpartum period and an altered body image, and that the women generally found choosing between resuturing or conservative treatment difficult.
Journal Article
Women’s experiences following severe perineal trauma: a qualitative study
by
Schmied, Virginia
,
Priddis, Holly
,
Dahlen, Hannah
in
Adaptation, Psychological
,
Adult
,
Attitude of Health Personnel
2014
Background
Literature reports that the psychological impact for women following severe perineal trauma is extensive and complex, however there is a paucity of research reporting on women’s experience and perspective of how they are cared for during this time. The aim of this study was to explore how women experience and make meaning of living with severe perineal trauma.
Methods
A qualitative interpretive approach using a feminist perspective guided data collection and analysis. Data were collected through semi-structured face to face interviews with twelve women in Sydney, Australia, who had experienced severe perineal trauma during vaginal birth. Thematic analysis was used to analyse the data.
Results
Three main themes were identified:
The Abandoned Mother
describes how women feel vulnerable, exposed and disempowered throughout the labour and birth, suturing, and postpartum period and how these feelings are a direct result of the actions of their health care providers.
The Fractured Fairytale
explores the disconnect between the expectations and reality of the birth experience and immediate postpartum period for women, and how this reality impacts upon their ability to mother their newborn child and the sexual relationship they have with their partner.
A Completely Different Normal
discusses the emotional pathway women travel as they work to rediscover and redefine a new sense of self following severe perineal trauma.
Conclusion
How women are cared for during their labour, birth and postnatal period has a direct impact on how they process, understand and rediscover a new sense of self following severe perineal trauma. Women who experience severe perineal trauma and associated postnatal morbidities undergo a transition as their maternal body boundaries shift, and the trauma to their perineum results in an extended physical opening whereby the internal becomes external, and that creates a continual shift between self and other.
Journal Article
Midwives’ lived experience of a birth where the woman suffers an obstetric anal sphincter injury - a phenomenological study
by
Lindgren, Helena
,
Edqvist, Malin
,
Lundgren, Ingela
in
Adaptation, Psychological
,
Anal Canal - injuries
,
Annan medicin och hälsovetenskap
2014
Background
The occurrence of obstetric anal sphincter injuries (OASIS) has increased in most high-income countries during the past twenty years. The consequences of these injuries can be devastating for women and have an impact on their daily life and quality of health. The aim of this study was to obtain a deeper understanding of midwives’ lived experiences of attending a birth in which the woman gets an obstetric anal sphincter injury.
Methods
A qualitative study using phenomenological lifeworld research design. The data were collected through in-depth interviews with 13 midwives.
Results
The essential meaning of the phenomenon was expressed as a deadlock difficult to resolve between a perceived truth among midwives that a skilled midwife can prevent severe perineal trauma and at the same time a coexisting more complex belief. The more complex belief is that sphincter injuries cannot always be avoided. The midwives tried to cope with their feelings of guilt and wanted to find reasons why the injury occurred. A fear of being exposed and judged by others as severely as they judged themselves hindered the midwives from sharing their experience. Ultimately the midwives accepted that the injury had occurred and moved on without any definite answers.
Conclusions
Being caught between an accepted truth and a more complex belief evoked various emotions among the midwives. Feelings of guilt, shame and the midwife’s own suspicion that she is not being professionally competent were not always easy to share. This study shows the importance of creating a safe working environment in which midwives can reflect on and share their experiences to continue to develop professionally. Further research is needed to implement and evaluate the effect of reflective practices in relation to midwifery care and whether this could benefit women in childbirth.
Journal Article
Ingested cylindrical batteries in an incarcerated male: a caustic tale
2015
A 37-year-old incarcerated man presented to the accident and emergency department following the deliberate ingestion of eight cylindrical batteries. He also admitted to inserting a razor blade wrapped in cling-film into his rectum; in addition, he sustained a self-inflicted laceration to his left antecubital fossa, using the metal casing from a battery. His medical history included a borderline and emotionally unstable personality disorder. He had ingested several batteries 12 months previously and required an emergency laparotomy to retrieve them. On the present admission, as there was no clinical evidence of small bowel obstruction, he was treated conservatively with serial radiographs. Following conservative management, the batteries failed to progress through the gastrointestinal tract, hence a laparotomy was performed and all the batteries were extricated. This paper discusses the management and associated sequelae of patients presenting following the intentional ingestion of a battery.
Journal Article
Assessment of Disparities in the Use of Anxiolysis and Sedation Among Children Undergoing Laceration Repair
by
Grupp-Phelan, Jacqueline
,
Iyer, Srikant
,
Brodzinski, Holly
in
Anti-Anxiety Agents - therapeutic use
,
Anxiety - prevention & control
,
anxiolysis
2010
The aim of this study was to determine if race/ethnicity and socioeconomic status (SES) were associated with the provision of anxiolysis and/or sedation among children undergoing laceration repair.
A 1-year cross-sectional sample of children undergoing laceration repair in an urban tertiary-care pediatric emergency department was analyzed. Primary outcomes included the use of nonpharmacologic anxiolysis (presence of a child life specialist), pharmacologic anxiolysis, and procedural sedation. Predictors included race/ethnicity (Caucasian vs minority) and SES (represented by insurance status: private vs none/public). Bivariable analyses provided unadjusted odds ratios (ORs) for the association between predictors and outcomes, and logistic regression was used to obtain adjusted ORs for the provision of anxiolysis and sedation (adjusted for age, gender, acuity, provider type, length of laceration, complexity of repair, time of day, use of a topical anesthetic, and body site of laceration).
In the unadjusted analysis, a higher proportion of Caucasian children than minority children received nonpharmacologic anxiolysis and sedation, and a higher proportion of children with high SES received nonpharmacologic anxiolysis compared with children of low SES. However, these associations were not statistically significant once potential confounders were controlled in the adjusted analysis.
A very small proportion of children undergoing laceration repair at this single institution received pharmacologic anxiolysis and/or procedural sedation. We did not demonstrate racial/ethnic or socioeconomic disparities with respect to the management of procedure-related anxiety in children.
Journal Article
Laceration repair in children
2014
Issues faced in the management of lacerations in children include control of pain and distress, wound cleaning and closure, referral decisions, awareness of potential associated injuries and strategies to prevent complications and optimise cosmetic outcome. The possibility of non-accidental injury may also require exploration. This update will attempt to offer a current, evidence-informed approach to management of the most commonly seen lacerations, and discuss when specialist referral is appropriate. Successful laceration repair in children is a procedure that blends the arts of anaesthesia, distraction and reassurance with the mechanics of tissue repair itself. Although each laceration and each child deserves an individualised approach, certain principles remain consistent and provide the backbone of a decision-making structure in this therapeutic area.
Journal Article
Honoring body wisdom
2005
During my midwifery education, I was taught that there are a variety of \"techniques\" and \"remedies\" that midwives should use to prevent tearing: \"small\" episiotomies, prenatal perineal massage, hot compresses with herbs during pushing, warm oil, creative hand maneuvers, four-handed catches, counterpressure on the occiput, slow delivery of the head, etc. Because the mother has to push so much harder, she is often unaware of the messages her body sends to slow down and allow the tissues to stretch around the baby's head each step of the way.
Magazine Article