Effects of Robotic Pet and Video-Based Distraction on Pain, Fear, and Anxiety in Children During Venipuncture

Overview

The goal of this randomized controlled clinical trial is to evaluate the effects of robotic pet and video-based distraction on pain, fear, and anxiety in children aged 5-10 years undergoing venipuncture. The main questions it aims to answer are: * Does robotic pet distraction reduce pain, fear, and anxiety in children during venipuncture? * Does video-based distraction reduce pain, fear, and anxiety in children during venipuncture? * Are there differences in pain, fear, and anxiety among children receiving robotic pet distraction, video-based distraction, and routine care? Children who met the eligibility criteria were randomly assigned to one of three groups the robotic pet group, video-based distraction group, or control group using simple randomization. The randomization sequence was computer-generated using RANDOM.ORG and prepared by an independent statistician. The uploaded randomization record confirms that a random sequence of participant numbers from 1 to 81 was generated. Allocation concealment was maintained using sequentially numbered, sealed, opaque envelopes, which were opened after each participant was enrolled in the study. Participants: Robotic pet group: interacted with a robotic pet as a distraction intervention during venipuncture. Video-based distraction group: watched an animal video as a distraction intervention during venipuncture. Control group: received routine care during venipuncture without an additional distraction intervention. Researchers compared the three groups to determine the effects of robotic pet and video-based distraction on children's pain, fear, and anxiety during venipuncture.

Venipuncture is one of the most frequently encountered invasive procedures in pediatric healthcare and can be a significant source of pain, fear, and anxiety for children. Negative experiences associated with needle-related procedures may result in crying, distress, restlessness, avoidance, and difficulty cooperating with healthcare professionals. Therefore, effective management of children's physical and emotional responses during venipuncture is an important component of child-centered pediatric care. Non-pharmacological distraction strategies are commonly used to redirect children's attention away from painful or stressful medical procedures. Such approaches are particularly valuable in pediatric settings because they can be incorporated into routine clinical care without additional pharmacological exposure. Visual, auditory, and interactive stimuli may help children focus their attention on an engaging activity rather than on the venipuncture procedure. The study protocol therefore focuses on two different distraction approaches: an interactive robotic pet and video-based distraction. Robotic pets represent an emerging interactive approach to supporting children during stressful healthcare experiences. Unlike passive distraction strategies, interaction with a robotic pet may engage the child's attention through a tangible and responsive stimulus while also providing an emotionally supportive experience. Video-based distraction, in contrast, provides visual and auditory stimulation that may redirect the child's attention away from the medical procedure. Comparing these approaches within the same clinical procedure may provide useful evidence regarding different forms of non-pharmacological distraction in pediatric care. The rationale of the study is therefore not only to determine whether distraction is beneficial, but also to examine whether an interactive robotic approach differs from a video-based approach in children's procedural experiences. The study was conducted as a three-arm randomized controlled trial involving children undergoing venipuncture. Eligible children were randomly allocated to the robotic pet group, video-based distraction group, or routine care control group using simple randomization. A computer-generated randomization sequence was created using RANDOM.ORG by a statistician independent of the study. The generated randomization sequence included participant numbers from 1 to 81. To maintain allocation concealment, sequentially numbered, sealed, opaque envelopes were used and opened after enrollment of each participant. In the robotic pet group, children were introduced to the robotic pet and given an opportunity to interact with it in relation to the venipuncture procedure. The robotic pet was used as an interactive distraction stimulus. In the video-based distraction group, children were exposed to an animal video presented by the researcher as a visual-auditory distraction strategy. Children assigned to the control group underwent venipuncture according to routine clinical practice without an additional distraction intervention. Parents remained with their children during the procedure, and the venipuncture was performed by an experienced nurse. Children's responses were assessed in relation to the procedure according to the predefined study protocol, with assessments involving both the child and parent where applicable. By comparing an interactive robotic pet intervention, video-based distraction, and routine care within a randomized design, this study seeks to contribute evidence on practical, non-pharmacological approaches that may improve children's experiences during venipuncture. The findings may help inform the integration of developmentally appropriate and child-centered distraction strategies into pediatric nursing practice and support efforts to minimize negative procedural experiences in children.