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

NCT ID: NCT05882929

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-07-01

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.

Conditions

Pain, Postoperative; Surgery; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experiment 1: Watching Cartoons

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.

Group Type: EXPERIMENTAL

Watching Cartoons

Intervention Type: 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: ball spin

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.

Group Type: EXPERIMENTAL

ball spin

Intervention Type: 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.).

Control

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.).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Watching Cartoons

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

ball spin

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.).

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Sevinc Akkoyun

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Tas Arslan, professor

Role: STUDY_DIRECTOR

Selcuk University

Mehmet Sarıkaya, Doctor

Role: STUDY_CHAIR

Selcuk University

Locations

Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sevinc Akkoyun, Phd

Role: CONTACT

sevincakkoyun87@gmail.com

+9003322231090

Facility Contacts

Selcuk University

Role: primary

Other Identifiers

2021/45

Identifier Type: -

Identifier Source: org_study_id