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

April 11, 2025 updated by: Atiye Karakul, Tarsus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tarsus, Turkey
        • Tarsus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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.
Experimental: 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 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.
Experimental: 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.
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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fear level
Time Frame: 1 day
Fear Scale: It was developed by Thurillet et al. to evaluate children's fears based on self-report of children aged 4-12 years. Turkish validity and reliability study was conducted by Tavşan et al. The scale consists of six facial expressions. The scale grades fear with a score ranging from 0 to 10 (gradually graded two by two) consistent with pain rating scales. The first facial expression indicates that there is no fear, the fear increases from right to left, and the sixth facial expression indicates that the level of fear is the highest.
1 day
pain level
Time Frame: 1 day
Numerical Pain Scale, this method, which aims to determine the severity of pain, aims to explain the patient's pain with numbers. In numerical scales, absence of pain (0) is evaluated as unbearable pain.
1 day
Satisfaction level
Time Frame: 1 day
The Child Satisfaction Scale was developed by the researchers in line with the literature in a way that pediatric patients can easily understand. The numbers between 0 and 10 were placed on a horizontal line by circling the point corresponding to the satisfaction of the children with the education given. In the scale, 0 points means 'not satisfied at all' and 10 points means 'extremely satisfied'.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Actual)

April 11, 2025

Study Completion (Actual)

April 11, 2025

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-8-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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