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

Tarsus University

Status: Completed

Conditions: Fear; Satisfaction; Pain

Treatments: Other: vibration and ice group; Other: vibration group; Other: cold application group

Study type: Interventional

Funder types: Other

Identifiers

NCT06611085

2024-8-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• To be between 7-12 years old
• Blood glucose monitoring of the child
• Measurement of blood glucose at least 4 times a day
• Volunteering to participate in the study

Exclusion criteria

• Having another chronic disease
• Use of painkillers
• Communication, mental or neurological problems
• Having a skin condition on the finger

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

cold application group

Experimental group

Description:

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.

Treatment:

Other: cold application group

vibration group

Experimental group

Description:

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.

Treatment:

Other: vibration group

vibration and ice group

Experimental group

Description:

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.

Treatment:

Other: vibration and ice group

Control

No Intervention group

Description:

After determining the hands for intervention and control, measurement 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.