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Completed NCT07763730

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

Conditions: Procedural Pain, Anxiety, Procedural Fear in Children

Sex: All
Ages: 5 Years – 10 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 90
Sponsor: Akdeniz University

Location: Kepez State Hospital Antalya Antalya

Summary

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.

Eligibility Criteria

Inclusion Criteria: Children aged 5-10 years. * Children who had not received analgesic medication within the previous 6 hours. * Children and their parents who were able to read and understand Turkish. * Children with no hearing or auditory problems. * Children whose cognitive and motor development was sufficient to interact with the robotic pet and participate in the video-based intervention. * Children and their parents who voluntarily agreed to participate in the study and provided written informed consent/assent, as applicable. Exclusion Criteria: * Children who did not meet the inclusion criteria. * Children who did not wish to continue participating in the study. * Children whose parents withdrew consent during the study. * Children who were unable to complete the study procedures or assessments.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07763730). StuddyBuddy aggregates publicly available trial information.