Clinical trial NCT04067206: The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Premature Infant
Keywords: Premature
Pain
Comfort
Auditory Interventions
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 256
Sex: ALL
Minimum age (years): 31
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This experimental study is a randomized controlled research. The infants were randomly assigned to four groups. Three interventions, each alone and in combination, are evaluated in parallel against a control group
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Born by cesarean section
* Non-supported by a mechanical ventilator or NCPAP
* Started to feed
* Within the first 10 days of postnatal

Exclusion Criteria:

* Had a major congenital malformation,
* Apgar score was less than 5 in the 1st-minute and less than 7 in the 5th-minute
* Received a sedative, muscle relaxant, corticosteroid, or analgesic therapy,
* First blood sampling attempt was unsuccessful
* MiniMuffs moved from their ears during the procedure
* Mothers who had problems recording their voice.

Primary outcomes:
measure: Pain (Neonatal Infant Pain Scale-NIPS)
timeFrame: During procedure
measure: COMFORT (COMFORTneo Scale)
timeFrame: during procedure
Secondary outcomes:
measure: Heart rates
timeFrame: heart rate values recorded 5 minutes and 1 minute before the procedure, during the procedure, and 1 minute and 5 minutes after the procedure.
measure: Crying time
timeFrame: during procedure
measure: the oxygen saturation
timeFrame: oxygen saturation values recorded 5 minutes and 1 minute before the procedure, during the procedure, and 1 minute and 5 minutes after the procedure.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Nursing
Study officials:
affiliation: Ege University
name: Zümrüt Başbakkal, Professor
role: STUDY_DIRECTOR
References:
citation: Chirico G, Cabano R, Villa G, Bigogno A, Ardesi M, Dioni E. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit. Acta Paediatr. 2017 Oct;106(10):1564-1568. doi: 10.1111/apa.13944. Epub 2017 Jul 5.
citation: Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.