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

NCT07763730 | Completed

• 1 other identifier: AKD-RPV-2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Procedural Pain; Anxiety; Procedural Fear in Children

Keywords

Venipuncture; Non-pharmacological Intervention; Pediatric Nursing; Procedural Anxiety; Procedural Fear; Procedural Pain; Distraction; Video Distraction; Robotic Pet; Children

Outcome Measures

Primary Outcomes (3)

• Pain Level During Venipuncture

  Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces representing increasing levels of pain and is scored from 0 (no pain) to 10 (worst pain). Higher scores indicate greater pain intensity. Pain was evaluated by the child and parent.

  Before, during, and immediately after venipuncture

• Fear

  Fear was assessed using the Children's Fear Scale (CFS). The scale consists of five facial expressions and is scored from 0 (no fear) to 4 (extreme fear). Higher scores indicate greater fear. Fear was evaluated by the child and parent

  Before, during, and immediately after venipuncture

• State Anxiety

  State anxiety was assessed using the Children's State Anxiety Scale (CSA). Higher scores indicate higher levels of state anxiety.

  Before, during, and immediately after venipuncture

Study Arms (3)

Robotic Pet Group

EXPERIMENTAL

Children assigned to this group received robotic pet-based distraction in relation to the venipuncture procedure. The child was introduced to the robotic pet and allowed to interact with it as a non-pharmacological distraction intervention.

Behavioral: Robotic Pet-Based Distraction

Video-Based Distraction Group

EXPERIMENTAL

Children assigned to this group watched an video as a visual and auditory distraction intervention in relation to the venipuncture procedure.

Behavioral: Video-Based Distraction

Control Group

NO INTERVENTION

Children assigned to the control group received routine care during venipuncture without an additional distraction intervention.

Interventions

Robotic Pet-Based Distraction BEHAVIORAL

Children assigned to the robotic pet group interacted with a robotic pet as a non-pharmacological distraction intervention during the venipuncture procedure. The robotic pet was introduced to the child before the procedure, and the child was allowed to interact with it before, during, and immediately after venipuncture. The intervention was designed to redirect the child's attention from the procedure and reduce procedure-related pain, fear, and anxiety.

Robotic Pet Group

Video-Based Distraction BEHAVIORAL

Children assigned to the video-based distraction group watched an animal video as a non-pharmacological visual and auditory distraction intervention. The video was presented before, during, and immediately after the venipuncture procedure to redirect the child's attention from the procedure and reduce procedure-related pain, fear, and anxiety.

Video-Based Distraction Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (2)

Kepez State Hospital

Antalya, Antalya, 07000, Turkey (Türkiye)

Location

Akdeniz University

Kumluca, Antalya, 07000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Bahar Aksoy, PhD

  https://kumlucasbf.akdeniz.edu.tr/tr

  PRINCIPAL INVESTIGATOR

• Edanur Tar Bolacali, PhD

  https://www.ahievran.edu.tr/

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study used a three-arm parallel randomized controlled design. Eligible children were randomly allocated to the robotic pet, video-based distraction, or routine care control group using a computer-generated simple randomization sequence. The randomization sequence was generated using RANDOM.ORG by an independent statistician. Allocation concealment was maintained using sequentially numbered, sealed, opaque envelopes that were opened after participant enrollment.

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: July 13, 2026
• Primary Completion: August 7, 2026
• Study Completion: August 7, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)