Procedural PainRCTNCT07763730
Effects of Robotic Pet and Video-Based Distraction on Pain, Fear, and Anxiety in Children During Venipuncture
A study testing Robotic Pet-Based Distraction and Video-Based Distraction in people with Procedural Pain and Anxiety, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Anxiety, Procedural Fear in Children
- What is being tested?
- Robotic Pet-Based Distraction and Video-Based Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 Jul 2026to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kepez State Hospital
Antalya, Antalya, 07000
Akdeniz University
Kumluca, Antalya, 07000
About this study
Official title: Effects of Robotic Pet and Video-Based Distraction on Pain, Fear, and Anxiety in Children During Venipuncture: A Randomized Controlled Trial
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?
Read more
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.
- Conditions
- Procedural Pain, Anxiety, Procedural Fear in Children
- Being tested
- Robotic Pet-Based Distraction, Video-Based Distraction
- Keywords
- Venipuncture, Non-pharmacological Intervention, Pediatric Nursing, Procedural Anxiety, Procedural Fear, Procedural Pain, Distraction, Video Distraction, Robotic Pet, Children
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Pet-Based DistractionBehavioural
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.
Video-Based DistractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Video-Based Distraction |
| Control Group | No intervention | Children assigned to the control group received routine care during venipuncture without an additional distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before venipuncture, at needle insertion, and immediately after completion of 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
Measured: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.
State Anxiety
State anxiety was assessed using the Children's State Anxiety Scale (CSA). Higher scores indicate higher levels of state anxiety.
Measured: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start13 Jul 2026
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Aksoy, Akdeniz University
- Investigators
- Bahar Aksoy, PhD, Principal investigator, https://kumlucasbf.akdeniz.edu.tr/trEdanur Tar Bolacali, PhD, Principal investigator, https://www.ahievran.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763730
- Sponsor's protocol ID
- AKD-RPV-2026
- Acronym
- RCT
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the confidentiality and privacy of the child participants.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic Pet and Video-Based Distraction on Pain, Fear, and Anxiety in Children During Venipuncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07763730
- Acronym / sponsor ID
- RCT / AKD-RPV-2026
- Conditions
- Procedural Pain, Anxiety, Procedural Fear in Children
- Keywords
- Venipuncture, Non-pharmacological Intervention, Pediatric Nursing, Procedural Anxiety, Procedural Fear, Procedural Pain, Distraction, Video Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robotic Pet Group | Experimental | Behavioral: Robotic Pet-Based DistractionChildren 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. |
| Video-Based Distraction Group | Experimental | Behavioral: Video-Based DistractionChildren assigned to this group watched an video as a visual and auditory distraction intervention in relation to the venipuncture procedure. |
| Control Group | No intervention | –Children assigned to the control group received routine care during venipuncture without an additional distraction intervention. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Pet-Based DistractionChildren 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. | Behavioural | Robotic Pet Group |
| Video-Based DistractionChildren 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. | Behavioural | Video-Based Distraction Group |
Primary outcome
Pain Level During Venipuncture
Time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of 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.
Fear
Time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.
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
State Anxiety
Time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.
State anxiety was assessed using the Children's State Anxiety Scale (CSA). Higher scores indicate higher levels of state anxiety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the confidentiality and privacy of the child participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Aksoy, PhD principal investigator
https://kumlucasbf.akdeniz.edu.tr/tr
Edanur Tar Bolacali, PhD principal investigator
https://www.ahievran.edu.tr/
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Pet-Based Distraction and Video-Based Distraction in people with Procedural Pain and Anxiety, run by Akdeniz University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level During Venipuncture (time frame: Immediately before venipuncture, at needle insertion, and immediately after completion of venipuncture.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.