The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children

NCT ID: NCT06571123

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2025-07-30

Brief Summary

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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

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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

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Postoperative Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental Group: group using interactive floor

Postoperative mobilization of children in this group will be provided on the interactive floor installed in the relevant ward.

Group Type EXPERIMENTAL

İnteractive floor

Intervention Type OTHER

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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İnteractive floor

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Aydın University

OTHER

Sponsor Role lead

Responsible Party

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Huriye Karadede

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huriye Karadede

Role: PRINCIPAL_INVESTIGATOR

Istanbul Aydın University

Locations

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Istanbul University Cerrahpaşa Cerrahpasa Faculty of Medicine

Bakırköy, Istanbul, Turkey (Türkiye)

Site Status

Istanbul Aydin University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 36437131 (View on PubMed)

Other Identifiers

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IstanbulAU Nursing Department

Identifier Type: -

Identifier Source: org_study_id

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