NCT06611085

Cold Application, Vibration and Vibrating Ice on Pain, Fear and Satisfaction Level in Children

The Effect of Cold Application, Vibration and Vibrating Ice on Pain, Fear and Satisfaction Level in Children Aged 7-12 Years Who Underwent Blood Glucose Level Measurement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tarsus University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to determine the effects of cold application, vibration and vibrating ice on pain, fear and satisfaction levels in children aged 7-12 years who underwent blood glucose level measurement.The population of the study will consist of children aged 7-12 years who receive treatment and care in the pediatric ward of the Ministry of Health, University of Health Sciences, Izmir Tepecik Training and Research Hospital between July 2024 and July 2025. Descriptive Information Form, Child Fear Scale, Numerical Pain Scale and Child Satisfaction Scale will be used to collect the research data.

Detailed description

Pain and painful experiences make the child more vulnerable to pain. Since it is not possible to eliminate the feeling of pain in pediatric patients, effective pain management has an important place . This study aimed to determine the effects of cold application, vibration and vibrating ice on pain, fear and satisfaction levels in children aged 7-12 years who underwent blood glucose level measurement.The population of the study will consist of children aged 7-12 years who receive treatment and care in the pediatric ward of the Ministry of Health, University of Health Sciences, Izmir Tepecik Training and Research Hospital between July 2024 and July 2025. Collection of Research Data The study will be started after ethics committee approval and written institutional authorisation. Data will be collected before blood glucose measurement according to the clinical routine and the time of blood glucose measurement of the child. In the collection of data, pediatric patients admitted to the paediatric ward and their parents who meet the inclusion criteria of the study and agree to participate in the study will be informed about the purpose of the study and the study and their verbal and written permissions will be obtained. * Data collection forms (Descriptive Information Form, Fear Scale) will be applied to the children and parents in the sample group. Fear assessment of the child will be done by the child, nurse and parent. * The hand to be used for intervention will be determined by lottery. Cards labelled right and left will be prepared and the child will be asked to draw from the envelope in a closed manner. * After determining the hands for intervention and control, measurements will be made according to the clinical routine for the first control. In clinical routine practice, in the measurement of blood glucose level, a puncture is performed with a lancet pen, then the first blood is wiped off and the second blood is measured with a glucometer. * Intervention: * The index finger of the child will be used in the cold application group. In this group, cold application will be performed by placing the index finger of the designated hand on a 10 x 10 cm ice pack for 30 seconds and then removing the ice pack immediately. * In the vibration group, the middle finger of the child will be used. In this group, vibration was applied by targeting the tip of the middle finger area using a vibrator device measuring 2x1x3 cm. The insertion of the needle will coincide with the application of the vibration stimulation. * In the vibration and ice group, cold and vibration stimulation will be applied to the child simultaneously. The ring finger of the designated hand was placed on a 10x10 cm ice pack for 30 seconds and subjected to cold application. Simultaneously, vibration stimulation will be applied to the tip of the middle finger area using a vibrator device with dimensions of 3x1 cm and 2x1 cm. After 30 seconds, the ice bag will be removed and the lancet pen will be adjusted for drilling from the fingertip while vibration stimulation continues. After blood glucose measurement, Fear Scale, Numerical Pain Scale and Child Satisfaction Scale will be applied after each non-pharmacological intervention. Fear and pain assessment of children will be done by the child, nurse and parent.

Conditions

• Fear
• Pain
• Satisfaction

Interventions

Type	Name	Description
OTHER	cold application group	The index finger of the child will be used in the cold application group. In this group, cold application will be performed by placing the index finger of the designated hand on a 10 x 10 cm ice pack for 30 seconds and then removing the ice pack immediately.
OTHER	vibration group	The middle finger of the child will be used in the vibration group. In this group, vibration was applied by targeting the tip of the middle finger area using a vibrator device measuring 2x1x3 cm. The insertion of the needle will coincide with the application of the vibration stimulation.
OTHER	vibration and ice group	In the vibration and ice group, cold and vibration stimulation will be applied to the child simultaneously. The ring finger of the designated hand was placed on a 10x10 cm ice pack for 30 seconds and subjected to cold application. Simultaneously, vibration stimulation will be applied to the tip of the middle finger area using a vibrator device with dimensions of 3x1 cm and 2x1 cm. After 30 seconds, the ice bag will be removed and the lancet pen will be adjusted for drilling from the fingertip while vibration stimulation continues.

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-04-11
• Completion: 2025-04-11
• First posted: 2024-09-24
• Last updated: 2025-04-15

Locations

1 site across 1 country: Turkey (Türkiye)