ClinicalTrials.gg
CompletedNCT07763730RCTUpdated Aug 19, 2026

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

An interventional study of Robotic Pet-Based Distraction and Video-Based Distraction in Procedural Pain, Anxiety and Procedural Fear in Children, sponsored by Akdeniz University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Akdeniz University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 78 studies in Pain, Procedural with a site in Turkey — 13 open to participants now, 13 under way, none of them phase 3. Pain, Procedural · Turkey.

Enrollment
45th of 76
90 · median 100
Started
2026
with 17 others
No phase
74 of 78
12 open now
Registered
67th of 78
by date
Lead sponsor
4 of 78
Akdeniz University

Among the 78 studies in Pain, Procedural with a site in Turkey, this one is the 45th largest by enrollment of the 76 interventional ones that give a count, is one of 18 that started in 2026, is one of 74 with no phase, and was the 67th registered.

Pain, Procedural

241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

Browse Pain, Procedural studies →

Open to participants now

13 of the 78 studies in Pain, Procedural with a site in Turkey are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 29 Pain, Procedural studies recruiting now, 13 (45%) set no upper age limit and 14 (48%) stop at 75 or younger; 14 take children under 18; 5 take healthy volunteers.

This study: 5 Years to 10 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 /assent, as applicable.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Robotic Pet Group

    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

  • Experimental
    Video-Based Distraction Group

    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

  • No intervention
    Control Group

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

Interventions

  • BehavioralRobotic Pet-Based Distraction

    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.

  • BehavioralVideo-Based Distraction

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.

  2. 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

    Time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.

  3. State Anxiety

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

    Time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.

07

Study locations

2 sites
  • Kepez State Hospital
    Antalya, Antalya 07000, Turkey (Türkiye)
  • Akdeniz University
    Kumluca, Antalya 07000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect the confidentiality and privacy of the child participants.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2026 to primary completion in Aug 2026, 0 months.

Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 0 months is below that.

Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2026
First posted
Aug 13, 2026
StartActual
Jul 13, 2026
Primary completionActual
Aug 7, 2026
CompletionActual
Aug 7, 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07763730
Lead sponsor
Akdeniz University
Responsible party
Bahar Aksoy (Assistant Professor, Akdeniz University) — Principal investigator
First posted
Aug 13, 2026
Start date
Jul 13, 2026
Primary completion
Aug 7, 2026
Completion
Aug 7, 2026
Last update
Aug 19, 2026

Study contacts

Bahar Aksoy, PhD
principal investigator · https://kumlucasbf.akdeniz.edu.tr/tr
Edanur Tar Bolacali, PhD
principal investigator · https://www.ahievran.edu.tr/

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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