Clinical trial NCT06571123: The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children
Official title: The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain Management
Keywords: Postoperative pain
pediatric surgery
nursing care
technology-based approach
mobilization
Interactive floor
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain Score
timeFrame: 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:
measure: Mobilization Time
timeFrame: 1st, 2nd and 3rd postoperative mobilization of the child. Each mobilization will take an average of 5-15 minutes.
Other outcomes:
Locations:
city: Bakırköy
country: Turkey
facility: Istanbul University Cerrahpaşa Cerrahpasa Faculty of Medicine
state: İ̇stanbul
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
affiliation: Istanbul Aydın University
name: Huriye Karadede
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.