Nonpharmacological Management of Postoperative Pain in Children
Condition: Orthopedic Disorder; Post Operative Pain
MeSH terms: Musculoskeletal Diseases; Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): Group to play online games; Group that received cold application; Group that received placebo (PHYSIOLOGICAL SALINE ISOTONIC 9 mg/ml AMPULE); Group that played an online game and received cold application at the same time
Intervention type(s): Other; Other; Drug; Other
Intervention description(s): 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
Other intervention name(s): PHYSIOLOGICAL SALINE ISOTONIC 9 mg/ml AMPULE
Allocation: Randomized
Intervention model: Factorial Assignment
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.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: postoperative pain; orthopedic and traumatology surgery; pediatri; cold application; placebo; online games