Clinical trial NCT05893680: Nonpharmacological Management of Postoperative Pain in Children
Official title: Comparison of the Effects of Online Games, Cold Applications and Placebo in Reducing Pain in Children Undergoing Orthopedic and Traumatology Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Post Operative Pain
Keywords: postoperative pain
orthopedic and traumatology surgery
pediatri
cold application
placebo
online games
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study was designed as a randomized controlled experiment to compare the effects of cold application, online gaming, and placebo on postoperative pain in children. Participants who met the selection criteria were randomly assigned to the "online gaming," "cold application," "placebo," and "online gaming and cold application" groups through a pre-determined lottery. Subsequently, the pain-reducing intervention specific to the assigned group was applied to the child who was randomized to that group.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study was designed as a randomized controlled trial to compare the effects of cold application, online gaming, and placebo on postoperative pain in children.

The sample size of the study was determined as 160 children, considering a 5% alpha error rate, 90% power, and the probability of loss of data during data collection, using G\*Power program (3.1.9.2.) According to this result, the population of the study is planned to be formed with 160 child patients, aged between 7-12, who are hospitalized in the Palace Lower Floor Orthopedics Service of Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital. The 160 children who make up the sample will be randomly assigned to "online game and cold application", "online game", "cold application", and "placebo" groups, previously sorted as group 1, group 2, group 3, and group 4 by the lottery method. In the study, the intervention of the relevant group will be applied to each child during pain control in each group.

A randomization list consisting of 40 blocks of four, based on age, gender, and the extremity region where the operation was performed, was created (https://www.randomizer.org/#randomize) to assign the children participating in the study to the groups randomly.

After the children were assigned to the intervention groups homogeneously and randomly, the study was started.

Before applying any pain-reducing interventions to all children in all the intervention groups, pain assessment was conducted using the visual analog scale (VAS) at 4 hours after surgery. The child's parent was also asked to evaluate the child's pain independently using the same scale. In this way, pre-intervention pain assessment was performed. Later, the pain-reducing intervention specific to the group in which the child was randomized was applied to the child.

The cold application group received a 20-minute application of cold gel that had been kept in the freezer for at least 2 hours on the surgical site of the children.

The children in the online game group were allowed to play a game they knew and wanted to play beforehand. This intervention lasted for 20 minutes.

The children in the group receiving both cold application and online game intervention were provided with the opportunity to play a previously known and desired online game while applying cold gel that had been kept in the freezer for at least 2 hours to the surgical site for 20 minutes. The intervention lasted for 20 minutes.

The children in the placebo group were administered 2 ml dose of sterile %0.9 saline solution (isotonic) intravenously. The mother and child were informed that the intervention administered during the procedure was a pain reliever.

After starting the pain-reducing interventions in all groups, pain assessment using VAS was repeated at 10 and 20 minutes with a double-blind technique by asking both the child and the parent. The cold application and online game interventions were stopped after the pain assessment at 20 minutes. Then, pain measurement with VAS was repeated at 40 minutes after the start of the pain-reducing interventions, and the measurement results were recorded to end the study.

In all groups, routine monitoring of fever, pulse, respiration, and saturation, which are already part of the clinic's standard practice, has been performed.

The assumptions of parametric tests for the obtained data will be evaluated to determine the appropriate statistical method, and data analysis will be performed. The results of the analysis will be interpreted, and the relevant data will be recorded.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Statistical analysis
timeFrame: 8 months
Secondary outcomes:
measure: Body weight
timeFrame: 8 months
measure: Height
timeFrame: 8 months
measure: pulse
timeFrame: 8 months
measure: respiration
timeFrame: 8 months
measure: body temperature
timeFrame: 8 months
measure: saturation
timeFrame: 8 months
Other outcomes:
measure: pain assessment
timeFrame: 8 months
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital.
state: Istanbul/Sarıyer
Study officials:
affiliation: İstanbulUC
name: İlke Karabıyık
role: PRINCIPAL_INVESTIGATOR
References: