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Clinical Trials/NCT05882929
NCT05882929
Recruiting
Not Applicable

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

Selcuk University1 site in 1 country120 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Selcuk University
Enrollment
120
Locations
1
Primary Endpoint
physiological parametres of the child: respiratory rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sevinc Akkoyun

assistant professor

Selcuk University

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

Outcomes

Primary Outcomes

physiological parametres of the child: respiratory rate

Time Frame: Just before the interventions and 5 minutes after the intervention

respiratory rate change

physiological parametres of the child: oxygen saturation (SpO2)

Time Frame: Just before the interventions and 5 minutes after the intervention

SpO2 level change

physiological parametres of the child: peak heart rate

Time Frame: Just before the interventions and 5 minutes after the intervention

heart rate change

pain level of children

Time Frame: Just before the interventions and 5 minutes after the intervention

Wong Baker Pain Faces Scale mean score Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It is measured before, at the 10th minute and after the intervention.

physiological parametres of the child: body temperature level

Time Frame: Just before the interventions and 5 minutes after the intervention

body temperature change

Study Sites (1)

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