Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:21 AM
Study NCT ID:
NCT04067206
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2019-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
The Effects Of White Noise, Recorded Mother's Voice, And Minimuffs (Earmuff) On Pain And Comfort In Premature Infants During Heel Lance: Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigated the effects of three interventions -recorded mother's voice, white noise, and MiniMuffs, muffs used to attenuate environmental sounds- applied during a heel lance on pain and comfort in premature infants. This randomized controlled research was conducted in a state hospital tertiary-level neonatal intensive care unit. Sixty-four premature neonates with a gestational age of 31-36 who were stable, didn't receive mechanic ventilation and has been started feeding participated. The infants were randomly assigned to four groups: i) white noise , ii) recorded mother's voice, iii) MiniMuffs (earmuff), and iv) control. Five minutes before the procedure the white noise and mother's voice played and MiniMuffs placed on babies' ears. The heel lance procedure was recorded on a camera. The camera recordings were evaluated for premature infants' pain and comfort according to the Neonatal Infant Pain Scale (NIPS) and the Comfort behavior (COMFORTneo) scale.
Detailed Description:
Auditory interventions are commonly used during procedural analgesic administration in premature neonates. This study investigated the effects of three interventions -recorded mother's voice, white noise, and MiniMuffs, muffs used to attenuate environmental sounds- applied during a heel lance on pain and comfort in premature infants. This experimental study is a randomized controlled research. The data for the research were collected between September 2017 - April 2019. The sample comprised 64 premature infants with gestational ages of 31-36 weeks, who had been hospitalized at the Neonatal Intensive Cate Units (NICU). All infants in the study were in their first postnatal week. The study routine included a heel lance procedure to determine the level of bilirubin and hematocrit. The heel lance was performed with a lancet and the blood was transferred to the hematocrit pipette. All heel lances were conducted by the same nurse. Power analysis was conducted to determine the number of samples needed. Predicting that the NIPS score would decrease by 30-35% and decrease from 6 to 4-4.5 with 0.05 error and 80% power, the intervention groups yielded 64 infants divided into four groups of 16 as the target sample number. 80 infants included in the study, taking into account the loss of sample. Sixteen infants were excluded from the study. Sixty-four premature infants submitted for heel lance were evaluated.The randomization list was prepared by a third person using R version 3.1.3 package program and considering the gender factor. The list was concealed from the researcher and the family of the baby, and it was given to the researcher only during the procedure. The infants were randomly assigned to four groups. The infants were randomly assigned to four groups: i) white noise , ii) recorded mother's voice, iii) MiniMuffs, and iv) control. Five minutes before the procedure the white noise and mother's voice played and MiniMuffs placed on babies' ears. Heel lance procedures were recorded with a camera. Camera recording started before the procedure and continued until the baby stopped crying. The videos evaluated independently by two scientists (observers) who were specialists in neonatal services and pain. Observers evaluated infants' comfort, pain, and distress based on NIPS and COMFORTneo. In order to evaluate the agreement between the observers for the total scores of NIPS and COMFORTneo, pain estimation, and distress estimation, intraclass correlation coefficient were determined.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: