Nonpharmacological Management of Postoperative Pain in Children
Comparison of the Effects of Online Games, Cold Applications and Placebo in Reducing Pain in Children Undergoing Orthopedic and Traumatology Surgery
1 other identifier
interventional
160
1 country
1
Brief Summary
The 3 non-pharmacological methods of online gaming, cold application, and placebo were chosen to reduce postoperative pain in children undergoing orthopedic and traumatology surgery. The effect of these 3 non-pharmacological methods on pain reduction was measured and compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2022
CompletedFirst Submitted
Initial submission to the registry
April 8, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedJune 22, 2023
June 1, 2023
5 months
April 8, 2023
June 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Statistical analysis
The data will be analyzed by deciding on the relevant statistical method by evaluating whether the assumptions of parametric tests are met. The analysis results will be interpreted, and the relevant data will be recorded.
8 months
Secondary Outcomes (6)
Body weight
8 months
Height
8 months
pulse
8 months
respiration
8 months
body temperature
8 months
- +1 more secondary outcomes
Other Outcomes (1)
pain assessment
8 months
Study Arms (4)
Group to play online games
EXPERIMENTALThe child's pain was evaluated 4 hours after the surgery, and then he/she was allowed to play an online game that he/she knew, loved, and wanted to play for 20 minutes.
Group that received cold application
EXPERIMENTALThe child's pain was evaluated 4 hours after the surgery, and then a clean gauze wrapped cold gel pack was applied to the surgical site for 20 minutes.
Group that received placebo
PLACEBO COMPARATORThe child in the relevant group had their pain evaluated 4 hours after the surgery, and then was given 2 cc of 0.9% saline (isotonic) solution intravenously, while being told that it was a painkiller administered to both the child and the parent.
"Group that played an online game and received cold application at the same time
ACTIVE COMPARATORPain assessment was performed on the child in the relevant group 4 hours after surgery, and then while playing an online game that the child knew, liked, and wanted to play, a clean gauze-wrapped cold gel pack was applied to the surgical site for cold therapy. The interventions lasted for 20 minutes.
Interventions
Playing games in children is one of the non-pharmacological pain relief methods. In this study, the effect of playing an online game on pain level in children who underwent orthopedic surgery for pain management after the surgery was measured.
Previous studies have demonstrated that cold application has anti-inflammatory, muscle spasm reducing, and pain relieving properties. In this study, the effect of cold application on pain level in children who underwent orthopedic surgery was investigated.
The placebo effect has been demonstrated in various studies today. Some of these studies describe placebo analgesia. In this study, the placebo analgesic effect was investigated, and the child and parent were told that an analgesic was applied, but instead 2 cc of PF 0.9% ISOTONIC SODIUM CHLORIDE solution was intravenously administered.
To investigate the combined effect of online gaming and cold application as two separate non-pharmacological interventions, both interventions were applied together in this group
Eligibility Criteria
You may qualify if:
- Being in the 7-12 age group
- Having undergone lower or upper extremity surgery
- Receiving general anesthesia during surgery
- Having a body temperature not higher than 37.5°C
- Those who are hospitalized in the orthopedic service and agree to participate along with their parents.
You may not qualify if:
- After the surgery, children who had intense pain in the first 4 hours and were given analgesics, children under 7 or over 12 years old, children with a fracture in the active arm for the online game group, children with a fever above 37.5°C, patients who were not fully recovered at 4 hours after the surgery and could not communicate, patients with mental motor development retardation, patients with plaster treatment for the cold application group, patients who received botulinum toxin injection during surgery and patients who underwent biopsy will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- İlke Karabıyıklead
Study Sites (1)
Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital.
Istanbul, Istanbul/Sarıyer, 34470, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
İlke Karabıyık
İstanbulUC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
April 8, 2023
First Posted
June 8, 2023
Study Start
August 4, 2021
Primary Completion
January 5, 2022
Study Completion
April 5, 2022
Last Updated
June 22, 2023
Record last verified: 2023-06