Nonpharmacological Management of Postoperative Pain in Children

NCT ID: NCT05893680

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2022-04-05

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.

Conditions

Orthopedic Disorder; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group to play online games

The 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 Type: EXPERIMENTAL

Group to play online games

Intervention Type: OTHER

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.

Group that received cold application

The 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 Type: EXPERIMENTAL

Group that received cold application

Intervention Type: OTHER

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.

Group that received placebo

The 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 Type: PLACEBO_COMPARATOR

Group that received placebo (PHYSIOLOGICAL SALINE ISOTONIC 9 mg/ml AMPULE)

Intervention Type: DRUG

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.

"Group that played an online game and received cold application at the same time

Pain 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.

Group Type: ACTIVE_COMPARATOR

Group that played an online game and received cold application at the same time

Intervention Type: OTHER

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

Interventions

Group to play online games

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.

Intervention Type: OTHER

Group that received cold application

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.

Intervention Type: OTHER

Group that received placebo (PHYSIOLOGICAL SALINE ISOTONIC 9 mg/ml AMPULE)

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.

Intervention Type: DRUG

Group that played an online game and received cold application at the same time

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

Intervention Type: OTHER

Other Intervention Names

PHYSIOLOGICAL SALINE ISOTONIC 9 mg/ml AMPULE

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

İlke Karabıyık

OTHER

Sponsor Role: lead

Responsible Party

İlke Karabıyık

Nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

İlke Karabıyık

Role: PRINCIPAL_INVESTIGATOR

İstanbulUC

Locations

Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital.

Istanbul, Istanbul/Sarıyer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1122

Identifier Type: -

Identifier Source: org_study_id