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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05882929
Enrollment
120
Registered
2023-05-31
Start date
2023-03-01
Completion date
2024-07-01
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Surgery, Child, Only

Keywords

Pain, Surgery, Pediatric, Postoperative

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.

Interventions

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.).

OTHERball 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.).

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Single (participant, outcomes assessor)

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain level of childrenJust before the interventions and 5 minutes after the interventionWong 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 levelJust before the interventions and 5 minutes after the interventionbody temperature change
physiological parametres of the child: peak heart rateJust before the interventions and 5 minutes after the interventionheart rate change
physiological parametres of the child: respiratory rateJust before the interventions and 5 minutes after the interventionrespiratory rate change
physiological parametres of the child: oxygen saturation (SpO2)Just before the interventions and 5 minutes after the interventionSpO2 level change

Countries

Turkey (Türkiye)

Contacts

Primary ContactSevinc Akkoyun, Phd
sevincakkoyun87@gmail.com+9003322231090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026