The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in childre

Not Applicable

• Conditions: The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children.

• Registration Number: IRCT20190603043812N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

The child should be conscious and not have any identified problem in mental, hearing, sight, and verbal abilities.
No presence of scar, wound or damage in the point the device is put
No usage of painkillers or anxiety-reducing medications in the past 8 hours
No presence of cold sensitive diseases like Reynolds and local neural anesthesia.
6-year-old children who were clients of selected clinic which is under supervision of Qom University of Medical Sciences for vaccination and were qualified and eager to take part in the research.

Exclusion Criteria

No toleration the device by the child during the procedure

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The score of pain in Wong-Baker Faces Pain Rating Scale. Timepoint: After vaccination, the child is asked to choose the smiley which corresponds to the severity of the pain they experienced. Supervising nurse also chooses the smiley corresponding to severity of child’s pain with a certain tool. Method of measurement: Questioner.;The score of anxiety in The Children Emotional Manifestation Scale. Timepoint: This scale is completed in two steps by the supervising nurse (researcher). After choosing the group randomly and before entering the vaccination room, child’s anxiety is measured and recorded based on their emotional demonstration scale. Then the anxiety is measured and recorded immediately after disinfecting the injection point and during injection of the vaccine. Method of measurement: Questioner.