- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067206
The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants
January 22, 2020 updated by: Ayşe Kahraman, Ege University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
256
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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İzmir, Turkey, 35100
- Ege University Faculty of Nursing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recorded mothers' voice group.
The mothers of the babies were given voice recorders and asked to record their voice in a comfortable room saying whatever they wanted to their baby.
Each mother recorded her voice for 3-5 minutes.
The voice recorder was placed at the baby's foot five minutes before the procedure and then played to the baby during the procedure.The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.
|
The mothers of the babies were given voice recorders and asked to record their voice in a comfortable room saying whatever they wanted to their baby.
Each mother recorded her voice for 3-5 minutes.
The voice recorder was placed at the baby's foot five minutes before the procedure and then played to the baby during the procedure.The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.
|
Experimental: White Noise
The white noise was started five minutes before the heel lance and was played to the baby during the procedure.
Dr. Harvery Karp's "The Happiest Baby," which consists of only intrauterine sounds, was used.
The speakers were placed at a distance of about 30 cm from the foot of the neonate.
The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.
|
The white noise was started five minutes before the heel lance and was played to the baby during the procedure.
Dr. Harvery Karp's "The Happiest Baby," which consists of only intrauterine sounds, was used.
The speakers were placed at a distance of about 30 cm from the foot of the neonate.
The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.
|
Experimental: MiniMuffs
MiniMuffs placed on their ears five minutes before the procedure to reduce the environmental noise.
Latus MiniMuffs - Neonatal Noise Attenuators have been developed for newborns and premature babies.
MiniMuffs protect the sensitive ears of the premature and provide a safe environment for healthy development.
|
MiniMuffs placed on their ears five minutes before the procedure to reduce the environmental noise.
Latus MiniMuffs - Neonatal Noise Attenuators have been developed for newborns and premature babies.
MiniMuffs protect the sensitive ears of the premature and provide a safe environment for healthy development.
|
No Intervention: Control Group
The control group who were administered standard care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Neonatal Infant Pain Scale-NIPS)
Time Frame: During procedure
|
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.
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During procedure
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COMFORT (COMFORTneo Scale)
Time Frame: during procedure
|
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.
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during procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rates
Time Frame: heart rate 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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Heart rates were monitored using Pulse Oximetry and were video-recorded.
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heart rate 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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Crying time
Time Frame: during procedure
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Crying duration was noted by watching video recordings.
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during procedure
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the oxygen saturation
Time Frame: 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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oxygen saturation was monitored using Pulse Oximetry and were video-recorded.
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zümrüt Başbakkal, Professor, Ege University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2017
Primary Completion (Actual)
June 21, 2018
Study Completion (Actual)
April 13, 2019
Study Registration Dates
First Submitted
August 21, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 26, 2019
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17HEF001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data sharing plans for the current study are unknown and will be made available at a later date.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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