NCT06571123

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

August 13, 2024

Last Update Submit

November 27, 2025

Conditions

Keywords

Postoperative painpediatric surgerynursing caretechnology-based approachmobilizationInteractive floor

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    1st, 2nd and 3rd postoperative mobilization of the child. Each mobilization will take an average of 5-15 minutes.

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group: group using interactive floor

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University Cerrahpaşa Cerrahpasa Faculty of Medicine

Bakırköy, Istanbul, 34295, Turkey (Türkiye)

Location

Istanbul Aydin University

Istanbul, Istanbul, 34295, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Huriye Karadede

    Istanbul Aydın University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 26, 2024

Study Start

October 7, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

December 5, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

I don't want to mislead you as I'm just starting my research.

Locations