Pain, Fear, Pain Management
Conditions
Brief summary
This study aims to compare the effects of Buzzy®, a device that applies cold and vibration, and a stress ball on pain and fear during intravenous catheter insertion in children aged 7-12 years. It seeks to answer whether one method is more effective than the other in reducing children's pain and fear during the procedure.
Interventions
BEHAVIORALBuzzy
Before intravenous catheter insertion, the Buzzy® device was placed approximately 5 cm above the insertion site on the child's arm. After 15 seconds of cold and vibration, a research nurse inserted the catheter. The device remained in place until 5 minutes after the procedure and was disinfected before and after each use.
BEHAVIORALStress Ball
Before intravenous catheter insertion, children were given a stress ball to hold in the hand opposite the insertion site. A few seconds after they began squeezing the ball, the procedure started. Children were asked to continue squeezing and releasing the ball until catheter insertion was complete. The stress ball was disinfected before and after each use.
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 7-12 years * No chronic illness or intellectual or neurological disability * No acute pain at hospital admission * No neurodevelopmental disorder or life-threatening condition, such as sepsis, shock, or respiratory or cardiac arrest * No analgesic medication within 6 hours before the procedure * Both the child and parent able to speak and understand Turkish * No intravenous catheter insertion within the previous year
Exclusion criteria
* Hearing, visual, or cognitive impairment * Not accompanied by a primary caregiver (mother or father) * Unconscious upon hospital admission * More than one attempt required for intravenous catheter insertion in the emergency department
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear-Children's Fear Scale (CFS) | The Children's Fear Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion. | Children's Fear Scale (CFS): Developed by McMurtry and colleagues in 2011 and adapted into Turkish by Özalp Gerçeker and colleagues in 2018, the scale measures children's fear and anxiety. It has five facial expressions scored from 0 (no fear) to 4 (severe fear). In this study, the scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion. |
| Pain-Wong-Baker FACES Pain Rating Scale | The Wong-Baker FACES Pain Rating Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion. | Wong-Baker FACES Pain Rating Scale: Developed by Donna Wong and Connie Baker in 1981 and revised in 2012, this scale uses six faces to help children rate their pain. Scores range from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain. In this study, children will use the scale to rate their pain during intravenous catheter insertion. |
Countries
Turkey (Türkiye)
Outcome results
None listed