Trials / Completed
CompletedNCT04674982
Vibration and During Heel Lance Procedures in Newborns
The Effect of Vibration on Pain During Heel Lance Procedures in Newborns
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- University of Gaziantep · Academic / Other
- Sex
- All
- Age
- 1 Day – 30 Days
- Healthy volunteers
- Accepted
Summary
This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns. .
Detailed description
Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | a vibrating device | vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) |
Timeline
- Start date
- 2018-09-09
- Primary completion
- 2018-12-12
- Completion
- 2018-12-12
- First posted
- 2020-12-19
- Last updated
- 2020-12-22
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04674982. Inclusion in this directory is not an endorsement.