Premature Birth Clinical Trial
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
Verified date | January 2020 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 256 |
Est. completion date | April 13, 2019 |
Est. primary completion date | June 21, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 31 Weeks to 36 Weeks |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University Faculty of Nursing | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain (Neonatal Infant Pain Scale-NIPS) | Neonatal Infant Pain Scale: The Neonatal Infant Pain Scale (NIPS), developed by Lawrence et al. (1993), is a behavioral scale and can be used with both full-term and preterm infants. The Cronbach's alpha coefficients of the scale were 0.95, 0.87, and 0.88 before, during, and after the procedure, respectively. In NIPS, five behavioral indicators (facial expression, cry, arms, legs, and state of arousal) and one physiological parameter (breathing pattern) are assessed. Each behavioral indicator is scored with 0 or 1 except "cry", which has three descriptors (scored with a 0, 1, or 2). The total pain score ranges between 0 and 7 with 0-2 points indicating mild to no pain, 3-4 indicating mild to moderate pain, and >4 indicating severe pain. | During procedure | |
Primary | COMFORT (COMFORTneo Scale) | The COMFORTneo scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. As well as determining comfort, the COMFORTneo scale is a tool that includes the Numerical Assessment Scales, which allow nurses to assess the pain and distress of the baby. "Respiratory response" and "crying" scores were recorded from the infants connected to mechanical ventilators and spontaneously breathing infants, respectively. The lowest score on the scale is 6 and the highest is 30. If the total score of the scale is between 14-30, the baby has pain or distress, is uncomfortable, and needs intervention to provide comfort. In addition, 4-6 points from the Numerical Assessment Scales indicates moderate and 7-10 points indicates severe pain and distress.The validity and reliability study of the Turkish version of the scale was conducted. Cronbach's alpha coefficient of the scale was 0.82-0.92. | during procedure | |
Secondary | Heart rates | Heart rates were monitored using Pulse Oximetry and were video-recorded. | heart rate values recorded 5 minutes and 1 minute before the procedure, during the procedure, and 1 minute and 5 minutes after the procedure. | |
Secondary | Crying time | Crying duration was noted by watching video recordings. | during procedure | |
Secondary | the oxygen saturation | oxygen saturation was monitored using Pulse Oximetry and were video-recorded. | oxygen saturation values recorded 5 minutes and 1 minute before the procedure, during the procedure, and 1 minute and 5 minutes after the procedure. |
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