Clinical Research Directory

Reducing Fear and Anxiety in Children Through Free Play

The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. The study population consisted of children aged 5-10 years and their parents who underwent planned surgical procedures in the pediatric surgery ward of a training and research hospital. Eligible child-parent dyads were recruited using a convenience sampling method and were then randomly assigned to the intervention and control groups. The data collection process in the study was conducted in two stages, with intervention and control groups: pretest and posttest. Tests for both groups were administered before the planned surgical procedure. A pretest for the children and their parents in the intervention group was administered approximately 2 hours before the surgical procedure, just before the start of the free-play intervention. At this stage, baseline data were obtained by measuring the children's fear and state anxiety levels and the parents' anxiety levels. Following this, the children participated in approximately 40 minutes of child-directed free play. A posttest was administered immediately after the free-play intervention, approximately 20 minutes before surgery. This measurement was used to evaluate the effect of free play on the dependent variables. In the control group, no study-related intervention was applied, and routine preoperative care continued. This group was also assessed with a pretest approximately 2 hours before surgery and a posttest after the corresponding 40-minute period, approximately 20 minutes before surgery, to evaluate the children's fear and state anxiety levels and parental anxiety. This allowed the differences between the two groups to be compared. This timing was selected to assess children's anxiety and fear during the period when preoperative distress was expected to be high and to evaluate the immediate effect of free play. Study Population: The study population consisted of children aged 5-10 years who underwent elective surgical procedures and their parents. Study Sample: The study included children aged 5-10 years who underwent surgical procedures and one accompanying parent for each child. The child-parent dyads were randomly assigned to the intervention and control groups. An a priori power analysis was performed using G\*Power version 3.1.9.7. Based on Cohen's d = 0.65, an α level of .05, statistical power of 80%, and a 1:1 allocation ratio, at least 39 child-parent dyads were required in each group. To account for potential attrition or missing data, 80 child-parent dyads were recruited, with 40 assigned to the intervention group and 40 assigned to the control group. The hypotheses of the study were: H1a: The posttest Children's Fear Scale scores of children in the free-play group are lower than their pretest scores. H1b: Children in the free-play group have lower posttest Children's Fear Scale scores than children in the control group. H2a: The posttest Children's Anxiety Meter-State scores of children in the free-play group are lower than their pretest scores. H2b: Children in the free-play group have lower posttest Children's Anxiety Meter-State scores than children in the control group. H3a: Parents in the free-play group have lower posttest anxiety scores than their pretest scores. H3b: Parents in the free-play group have lower posttest anxiety scores than parents in the control group. H4: There are positive associations among parental anxiety, children's state anxiety, and children's fear levels both before and after the intervention.

The Effect of Emotional Freedom Technique on Parents' Anxiety Level: Newborn Hearing Screening

Newborn hearing screening (NHS) is a standard procedure that often triggers acute anxiety in parents. While Emotional Freedom Technique (EFT) has demonstrated efficacy in reducing psychological distress across various clinical settings, its specific application to maternal anxiety during the neonatal screening period remains under-researched. This study addresses this gap by investigating the impact of a targeted EFT intervention on anxiety levels in mothers awaiting their newborns' first hearing tests. The primary objective is to determine if a brief, 15-minute EFT session reduces maternal anxiety more effectively than a standard waiting period. Participants were randomly assigned to either an intervention group, where they perform a structured acupoint tapping sequence, or a control group that received no active intervention. Anxiety was assessed using validated scales immediately before and after the 15-minute period to capture acute changes in distress. Due to clinical environment conditions and hospital accompaniment patterns, the study was completed with a final sample of 70 mothers.

Impact of Artificial Intelligence-Supported Educational Intervention on Mothers' Fever Management

This study aims to evaluate the effect of an artificial intelligence (AI)-based educational program on mothers' fever management practices and anxiety related to fever in children. Fever is a common symptom in pediatric patients, especially under the age of three, causing repeated health concerns for parents. Despite the prevalence of fever, parents often engage in inappropriate fever management practices, which may lead to unnecessary anxiety and improper care. The study was conducted as a pretest-posttest experimental design including 80 mothers of children who presented to the Pediatric Emergency Unit at Erciyes University, Fevzi Mercan-Mustafa Eraslan Children's Hospital. Participants were assigned to either an intervention group receiving AI-supported fever management education or a control group receiving standard care. Data were collected using validated scales to assess parental fever management practices and anxiety levels before and after the intervention. The educational material was developed using ChatGPT 4.0, a large language model AI platform, and reviewed by pediatric experts. The results of this study may improve fever management education and reduce anxiety among mothers, potentially leading to better health outcomes for children.

NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)

The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.