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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • İzmir, Turkey, 35100
        • Ege University Faculty of Nursing

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: RECORDED MOTHER'S VOICE
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.
Other: 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.
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.
Other: MiniMuff
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
During procedure
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.
during procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
Crying time
Time Frame: during procedure
Crying duration was noted by watching video recordings.
during procedure
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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