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The Effect of Distraction in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery

Primary Purpose

Pain, Postoperative, Surgery, Child, Only

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Watching Cartoons
ball spin
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring Pain, Surgery, Pediatric, Postoperative

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Selcuk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experiment 1: Watching Cartoons

Experiment 1: ball spin

Control

Arm Description

Watching Cartoon Movies will be performed after the child comes to the service after the operation and prepares for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). 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.

ball squeezing will be applied after the child comes to the service after the operation and the postoperative period preparation is made (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.). 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 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.).

Outcomes

Primary Outcome Measures

pain level of children
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
body temperature change
physiological parametres of the child: peak heart rate
heart rate change
physiological parametres of the child: respiratory rate
respiratory rate change
physiological parametres of the child: oxygen saturation (SpO2)
SpO2 level change

Secondary Outcome Measures

Full Information

First Posted
December 3, 2022
Last Updated
September 4, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05882929
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Surgery, Child, Only
Keywords
Pain, Surgery, Pediatric, Postoperative

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Single (participant, outcomes assessor)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment 1: Watching Cartoons
Arm Type
Experimental
Arm Description
Watching Cartoon Movies will be performed after the child comes to the service after the operation and prepares for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). 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.
Arm Title
Experiment 1: ball spin
Arm Type
Experimental
Arm Description
ball squeezing will be applied after the child comes to the service after the operation and the postoperative period preparation is made (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.). 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, the 10th and 20th minute physiological parameters and 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.).
Intervention Type
Other
Intervention Name(s)
Watching Cartoons
Intervention Description
The cartoon will be watched after the child comes to the service after the operation and the postoperative period is prepared (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.).
Intervention Type
Other
Intervention Name(s)
ball spin
Intervention Description
ball squeezing will be applied after the child comes to the service after the operation and after the postoperative period preparation is made (taking the vital signs, dressing the clothes, controlling the bleeding, telling the feeding time, etc.).
Primary Outcome Measure Information:
Title
pain level of children
Description
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.
Time Frame
Just before the interventions and 5 minutes after the intervention
Title
physiological parametres of the child: body temperature level
Description
body temperature change
Time Frame
Just before the interventions and 5 minutes after the intervention
Title
physiological parametres of the child: peak heart rate
Description
heart rate change
Time Frame
Just before the interventions and 5 minutes after the intervention
Title
physiological parametres of the child: respiratory rate
Description
respiratory rate change
Time Frame
Just before the interventions and 5 minutes after the intervention
Title
physiological parametres of the child: oxygen saturation (SpO2)
Description
SpO2 level change
Time Frame
Just before the interventions and 5 minutes after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevinc Akkoyun, Phd
Phone
+9003322231090
Email
sevincakkoyun87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Tas Arslan, professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mehmet Sarıkaya, Doctor
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42060
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selcuk University

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The effect of distraction methods on the postoperative period of pediatric patients undergoing outpatient surgery
IPD Sharing Time Frame
December 2022-July 2023 (7 months)

Learn more about this trial

The Effect of Distraction in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery

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