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

NCT06611085 | Completed

• 1 other identifier: 2024-8-17
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fear; Pain; Satisfaction

Keywords

fear; pain; satisfaction

Outcome Measures

Primary Outcomes (3)

• fear level

  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

  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

  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

Study Arms (4)

cold application group

EXPERIMENTAL

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

vibration group

EXPERIMENTAL

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

vibration and ice group

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

cold application group OTHER

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.

cold application group

vibration group OTHER

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.

vibration group

vibration and ice group OTHER

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.

vibration and ice group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Tarsus, Turkey (Türkiye)

Location

Related Publications (6)

• Al Hayek, A. A., Robert, A. A., Babli, S., Almonea, K. ve Al Dawish, M. A. (2017). Fear of Self-Injectingand Self-TestingandtheRelated Risk Factors in AdolescentswithType 1 Diabetes: A Cross-SectionalStudy. DiabetesTherapy, 8(1). doi:10.1007/s13300-016-0221-8

  BACKGROUND

• Andersson V, Bergman S, Henoch I, Simonsson H, Ahlberg K. Pain and pain management in children and adolescents receiving hospital care: a cross-sectional study from Sweden. BMC Pediatr. 2022 May 5;22(1):252. doi: 10.1186/s12887-022-03319-w.

  PMID: 35513880 BACKGROUND

• Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.

  PMID: 29728296 BACKGROUND

• Hanberger L, Tallqvist E, Richert A, Olinder AL, Forsner M, Morelius E, Nilsson S. Needle-Related Pain, Affective Reactions, Fear, and Emotional Coping in Children and Adolescents With Type 1 Diabetes: A Cross-Sectional Study. Pain Manag Nurs. 2021 Aug;22(4):516-521. doi: 10.1016/j.pmn.2021.01.007. Epub 2021 Feb 25.

  PMID: 33640255 BACKGROUND

• Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.

  PMID: 36737707 BACKGROUND

• Yaz SB, Basdemir S, Gectan E. The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Jan-Feb;74:77-84. doi: 10.1016/j.pedn.2023.11.018. Epub 2023 Nov 28.

  PMID: 38029689 BACKGROUND

MeSH Terms

Conditions

Pain; Personal Satisfaction

Interventions

Vibration

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Randomised controlled study

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: October 17, 2024
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)