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

NCT05882929 | Recruiting

• 1 other identifier: 2021/45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Surgery; Child, Only

Keywords

Pain; Surgery; Pediatric; Postoperative

Outcome Measures

Primary Outcomes (5)

• 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.

  Just before the interventions and 5 minutes after the intervention

• physiological parametres of the child: body temperature level

  body temperature change

  Just before the interventions and 5 minutes after the intervention

• physiological parametres of the child: peak heart rate

  heart rate change

  Just before the interventions and 5 minutes after the intervention

• physiological parametres of the child: respiratory rate

  respiratory rate change

  Just before the interventions and 5 minutes after the intervention

• physiological parametres of the child: oxygen saturation (SpO2)

  SpO2 level change

  Just before the interventions and 5 minutes after the intervention

Study Arms (3)

Experiment 1: Watching Cartoons

EXPERIMENTAL

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.

Other: Watching Cartoons

Experiment 1: ball spin

EXPERIMENTAL

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.

Other: ball spin

Control

NO INTERVENTION

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.).

Interventions

Watching Cartoons OTHER

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.).

Experiment 1: Watching Cartoons

ball spin OTHER

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.).

Experiment 1: ball spin

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fatma Tas Arslan, professor

  Selcuk University

  STUDY DIRECTOR

• Mehmet Sarıkaya, Doctor

  Selcuk University

  STUDY CHAIR

Central Study Contacts

Sevinc Akkoyun, Phd

CONTACT

+9003322231090; sevincakkoyun87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (participant, outcomes assessor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: May 31, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: December 2022-July 2023 (7 months)

Locations

TU (1)