Clinical trial NCT05882929: The Effect of Distraction in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery
Official title: The Effect of Distraction Methods on Pain Level and Physiological Parameters in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Surgery
Child, Only
Keywords: Pain
Surgery
Pediatric
Postoperative
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a randomized controlled trial. In this parallel group study, there will be two intervention groups (watching cartoons and ball squeezing) and a control group.
Primary purpose: OTHER

Brief summary: The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p\<0.05 level were considered statistically significant.

Detailed description: The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p\<0.05 level were considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Children aged 6-12 years
* Children with day surgery surgery
* Children with American Society of Anesthesiologists classification (ASA) I-II (ASA score is given in the preoperative period by the anesthesiologist)
* Parents who volunteered to participate in the study
* Turkish speaking children

Exclusion Criteria:

* Children who have had previous surgery
* Children with the American Society of Anesthesiologists classification (ASA) III
* Children with congenital anomalies, psychiatric, neurological and chronic diseases

Primary outcomes:
measure: pain level of children
timeFrame: Just before the interventions and 5 minutes after the intervention
measure: physiological parametres of the child: body temperature level
timeFrame: Just before the interventions and 5 minutes after the intervention
measure: physiological parametres of the child: peak heart rate
timeFrame: Just before the interventions and 5 minutes after the intervention
measure: physiological parametres of the child: respiratory rate
timeFrame: Just before the interventions and 5 minutes after the intervention
measure: physiological parametres of the child: oxygen saturation (SpO2)
timeFrame: Just before the interventions and 5 minutes after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Fatma Tas Arslan, professor
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Mehmet Sarıkaya, Doctor
role: STUDY_CHAIR
References: