Postoperative Pain ManagementNCT06571123
The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children
A study testing İnteractive floor in people with Postoperative Pain Management, run by Istanbul Aydın University at 2 sites in Turkey (Türkiye).
Trial summary
This research is planned to examine the effect of "interactive floor" on post-operative pain and mobilization in children within the scope of diversion method. Research Question: Does the interactive floor affect children's post operative pain and mobilization? Hypotheses of the Study: H0: There is no difference… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- İnteractive floor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Oct 2024to 30 Jul 2025
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Speak and understand Turkish
- Children whose parents agreed to participate in the study,
- Between 3 and 6 years old,
- Mobilization for the first time after surgical intervention
- No previous experience with other surgical procedures
- Ability to walk independently
- Children with vesico-uretero renal reflux, torsion of the ovarian pedicle of the ovary and fallopian tube, hypospadias, hirschsprung's disease, undescended testis, persistent cloaca, hydronephrosis, ureteropelvic junction obstruction, appendicitis, anus atresia/stenosis/fistula, biliary atresia, circumcision, phimosis and paraphimosis, post-traumatic surgery
Who cannot join
- Daily surgical procedures performed
- Having a health problem that prevents him/her from walking
- Serious complications after the operation
- Having any visual, auditory and mental problems
- The physician reports a problem that may prevent him/her from walking
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University Cerrahpaşa Cerrahpasa Faculty of Medicine
Bakırköy, Istanbul, 34295
Istanbul Aydin University
Istanbul, Istanbul, 34295
About this study
Official title: The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children; Randomized Controlled Trial
This research is planned to examine the effect of "interactive floor" on post-operative pain and mobilization in children within the scope of diversion method.
Research Question: Does the interactive floor affect children's post operative pain and mobilization?
Read more
Hypotheses of the Study:
H0: There is no difference between the postoperative pain score and mobilization time of children mobilized on the interactive floor and children mobilized with routine applications.
H1: Children mobilized on the interactive floor have lower pain scores than children in the control group.
H2: Children mobilized on the interactive floor have longer mobilization times than children in the control group.
H3: Children mobilized on the interactive floor have lower peak heart rate than children in the control group.
H4: Oxygen saturation of children mobilized on the interactive floor is higher than children in the control group.
Read the detailed description
Pre-Mobilization:
The data for the child and family in the Interactive floor group and the control group who agreed to participate in the study and whose consent was obtained will be recorded by the researcher in the 'Child and Family Introductory Information Form' before mobilization with the patient file and face-to-face interview technique. Immediately before the 1st, 2nd and 3rd mobilizations of the child participating in the study in the postoperative period, pain score, peak heart rate and oxygen saturation values will be recorded without the child getting out of bed (while resting in bed).
During Mobilization:
Experimental group: Mobilization of children in this group will be provided on the interactive floor installed in the relevant ward. During the 1st, 2nd and 3rd mobilization, the child will be accompanied by the parent, nurse and researcher. In addition, during the 1st, 2nd and 3rd mobilization (the mobilization time will be evaluated by taking into account the time from the child getting out of bed to returning to bed), the mobilization time of the children will be measured with a stopwatch by an observer nurse who is not involved in the study and recorded in the data collection form. The mobilization time will depend on the child's own will and no restrictive intervention will be made by the researcher. In addition, pain scores, peak heart rate and oxygen saturation values will be recorded during the 1st, 2nd and 3rd mobilization (after the child has finished walking and before/while standing on the bed).
Control group: Mobilization of children in this group will be provided in the corridor, which is the routine of the relevant service, and they will be prevented from seeing the interactive floor before mobilization. Children in this group will be allowed to use the interactive floor in their mobilization after their 3rd mobilization.
During mobilization, the child will be accompanied by his/her parent, nurse and researcher. During the 1st, 2nd and 3rd mobilization, the child will be accompanied by his/her parent, nurse and researcher. In addition, during the 1st, 2nd and 3rd mobilization (the mobilization time will be evaluated by considering the time from the time the child gets out of bed to the time the child returns to bed), the mobilization time of the children will be measured with a stopwatch by an observer nurse who is not involved in the study and recorded in the data collection form. The mobilization time will depend on the child's own will and no restrictive intervention will be made by the researcher. In addition, pain score, peak heart rate and oxygen saturation values will be recorded during the 1st, 2nd and 3rd mobilization (after the child has finished walking and before/while standing on the bed).
After Mobilization: Immediately after the 1st, 2nd and 3rd mobilizations of the children in both groups, pain scores, peak heart rate and oxygen saturation values of the children will be recorded when the child sits/ lies down on the bed and after the children rest in the bed for 15 minutes.
- Conditions
- Postoperative Pain Management
- Being tested
- İnteractive floor
- Keywords
- Postoperative pain, pediatric surgery, nursing care, technology-based approach, mobilization, Interactive floor
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İnteractive floorOther
Interactive floor The interactive floor system includes a computer, camera and projection. With the projection, videos that are ready on the computer are projected on the floor, image processing is done with the camera and it detects whether there is an object on the floor or not and creates effects on the video. For example, on the floor containing colored balloons, the balloons burst with the movement of the child. With this visual mobility, it is aimed to draw the child's attention to another direction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: group using interactive floor | Experimental | Postoperative mobilization of children in this group will be provided on the interactive floor installed in the relevant ward. Receives: Other: İnteractive floor |
| Control Group | No intervention | The postoperative mobilization of children in this group will be provided in the corridor, which is the routine of the relevant service, and they will be prevented from seeing the interactive floor before mobilization. Children in this group will be allowed to use the interactive floor in their mobilization after their 3rd mobilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Wong-Baker FACES Pain Rating Scale The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit". The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst". This pain scale was originally developed for children.
Measured: The child will be asked to rate the Wong-Baker FACES Pain Rating Scales 3 times: immediatelybefore mobilization, during mobilization and immediately after the mobilization.
Secondary outcomes (1)
Mobilization Time
Duration of the child's 1st, 2nd and 3rd postoperative mobilization The study is planned to be conducted at the first (approximately 8 hours after surgery), second (approximately 9 hours after surgery) and third (approximately 10 hours after surgery) postoperative mobilization of the children.
Measured: 1st, 2nd and 3rd postoperative mobilization of the child. Each mobilization will take an average of 5-15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start7 Oct 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huriye Karadede, Istanbul Aydın University
- Investigators
- Huriye Karadede, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571123
- Sponsor's protocol ID
- IstanbulAU Nursing Department
- Status last verified
- Dec 2024
- First submitted
- 13 Aug 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't want to mislead you as I'm just starting my research.
Publications
Topcu SY, Semerci R, Kostak MA, Guray O, Sert S, Yavuz G. The effect of an interactive robot on children's post-operative anxiety, mobilization, and parents' satisfaction; randomized controlled study. J Pediatr Nurs. 2023 Jan-Feb;68:e50-e57. doi: 10.1016/j.pedn.2022.11.009. Epub 2022 Nov 24.
PubMed 36437131
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06571123
- Acronym / sponsor ID
- IstanbulAU Nursing Department
- Conditions
- Postoperative Pain Management
- Keywords
- Postoperative pain, pediatric surgery, nursing care, technology-based approach, mobilization, Interactive floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Aug 2024 (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.
This research is planned to examine the effect of "interactive floor" on post-operative pain and mobilization in children within the scope of diversion method.
Research Question: Does the interactive floor affect children's post operative pain and mobilization?
Hypotheses of the Study:
H0: There is no difference between the postoperative pain score and mobilization time of children mobilized on the interactive floor and children mobilized with routine applications.
H1: Children mobilized on the interactive floor have lower pain scores than children in the control group.
H2: Children mobilized on the interactive floor have longer mobilization times than children in the control group.
H3: Children mobilized on the interactive floor have lower peak heart rate than children in the control group.
H4: Oxygen saturation of children mobilized on the interactive floor is higher than children in the control group.
Detailed description
Pre-Mobilization:
The data for the child and family in the Interactive floor group and the control group who agreed to participate in the study and whose consent was obtained will be recorded by the researcher in the 'Child and Family Introductory Information Form' before mobilization with the patient file and face-to-face interview technique. Immediately before the 1st, 2nd and 3rd mobilizations of the child participating in the study in the postoperative period, pain score, peak heart rate and oxygen saturation values will be recorded without the child getting out of bed (while resting in bed).
During Mobilization:
Experimental group: Mobilization of children in this group will be provided on the interactive floor installed in the relevant ward. During the 1st, 2nd and 3rd mobilization, the child will be accompanied by the parent, nurse and researcher. In addition, during the 1st, 2nd and 3rd mobilization (the mobilization time will be evaluated by taking into account the time from the child getting out of bed to returning to bed), the mobilization time of the children will be measured with a stopwatch by an observer nurse who is not involved in the study and recorded in the data collection form. The mobilization time will depend on the child's own will and no restrictive intervention will be made by the researcher. In addition, pain scores, peak heart rate and oxygen saturation values will be recorded during the 1st, 2nd and 3rd mobilization (after the child has finished walking and before/while standing on the bed).
Control group: Mobilization of children in this group will be provided in the corridor, which is the routine of the relevant service, and they will be prevented from seeing the interactive floor before mobilization. Children in this group will be allowed to use the interactive floor in their mobilization after their 3rd mobilization.
During mobilization, the child will be accompanied by his/her parent, nurse and researcher. During the 1st, 2nd and 3rd mobilization, the child will be accompanied by his/her parent, nurse and researcher. In addition, during the 1st, 2nd and 3rd mobilization (the mobilization time will be evaluated by considering the time from the time the child gets out of bed to the time the child returns to bed), the mobilization time of the children will be measured with a stopwatch by an observer nurse who is not involved in the study and recorded in the data collection form. The mobilization time will depend on the child's own will and no restrictive intervention will be made by the researcher. In addition, pain score, peak heart rate and oxygen saturation values will be recorded during the 1st, 2nd and 3rd mobilization (after the child has finished walking and before/while standing on the bed).
After Mobilization: Immediately after the 1st, 2nd and 3rd mobilizations of the children in both groups, pain scores, peak heart rate and oxygen saturation values of the children will be recorded when the child sits/ lies down on the bed and after the children rest in the bed for 15 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: group using interactive floor | Experimental | Other: İnteractive floorPostoperative mobilization of children in this group will be provided on the interactive floor installed in the relevant ward. |
| Control Group | No intervention | –The postoperative mobilization of children in this group will be provided in the corridor, which is the routine of the relevant service, and they will be prevented from seeing the interactive floor before mobilization. Children in this group will be allowed to use the interactive floor in their mobilization after their 3rd mobilization. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Speak and understand Turkish
- Children whose parents agreed to participate in the study,
- Between 3 and 6 years old,
- Mobilization for the first time after surgical intervention
- No previous experience with other surgical procedures
Key exclusion criteria (5 listed)
- Daily surgical procedures performed
- Having a health problem that prevents him/her from walking
- Serious complications after the operation
- Having any visual, auditory and mental problems
- The physician reports a problem that may prevent him/her from walking
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 |
|---|---|---|
| İnteractive floorInteractive floor The interactive floor system includes a computer, camera and projection. With the projection, videos that are ready on the computer are projected on the floor, image processing is done with the camera and it detects whether there is an object on the floor or not and creates effects on the video. For example, on the floor containing colored balloons, the balloons burst with the movement of the child. With this visual mobility, it is aimed to draw the child's attention to another direction. | Other | Experimental Group: group using interactive floor |
Primary outcome
Postoperative Pain Score
Time frame: The child will be asked to rate the Wong-Baker FACES Pain Rating Scales 3 times: immediatelybefore mobilization, during mobilization and immediately after the mobilization.
Wong-Baker FACES Pain Rating Scale The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit". The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst". This pain scale was originally developed for children.
1 secondary outcome
Mobilization Time
Time frame: 1st, 2nd and 3rd postoperative mobilization of the child. Each mobilization will take an average of 5-15 minutes.
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 5 Dec 2025.
- Results publication: PubMed 36437131Topcu SY, Semerci R, Kostak MA, Guray O, Sert S, Yavuz G. The effect of an interactive robot on children's post-operative anxiety, mobilization, and parents' satisfaction; randomized controlled study. J Pediatr Nurs. 2023 Jan-Feb;68:e50-e57. doi: 10.1016/j.pedn.2022.11.009. Epub 2022 Nov 24.
- Individual participant dataSharing planned: No. I don't want to mislead you as I'm just starting my research.
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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.
Huriye Karadede principal investigator
Istanbul Aydın University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İnteractive floor in people with Postoperative Pain Management, run by Istanbul Aydın 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 7 inclusion and 5 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 5 Dec 2025. 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?
Postoperative Pain Score (time frame: The child will be asked to rate the Wong-Baker FACES Pain Rating Scales 3 times: immediatelybefore mobilization, during mobilization and immediately after the mobilization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06571123, which also lists 1 linked publication.
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 5 Dec 2025.