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