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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190603043812N1

Enrollment

105

Registered

2019-09-08

Start date

2019-09-13

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: 1.Preparing Buzzy device, ice bag, and other necessary tools for vaccination. 2.Placing the ice bag under the device. 3.Selecting injection point. 4.Placing the Buz

Eligibility

Sex/Gender

All

Age

6 Years to 6 Years

Inclusion criteria

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

Exclusion criteria: No toleration the device by the child during the procedure

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Khoshqadam

Iran University of Medical Sciences

mary_khoshqadam@yahoo.com+98 25 3291 3346

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026