The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants

NCT04067206 | Completed

• 1 other identifier: 17HEF001
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Premature Infant

Keywords

Premature; Pain; Comfort; Auditory Interventions

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Heart rates

  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

  during procedure

• the oxygen saturation

  oxygen saturation values recorded 5 minutes and 1 minute before the procedure, during the procedure, and 1 minute and 5 minutes after the procedure.

Study Arms (4)

Recorded mothers' voice group.

EXPERIMENTAL

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

White Noise

EXPERIMENTAL

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

MiniMuffs

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group who were administered standard care.

Interventions

RECORDED MOTHER'S VOICE OTHER

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.

Recorded mothers' voice group.

White Noise OTHER

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.

White Noise

MiniMuff OTHER

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

Eligibility Criteria

• Age: 31 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Nursing

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28580602 BACKGROUND

• 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.

  PMID: 27751753 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zümrüt Başbakkal, Professor

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The infants were randomly assigned to four groups: i) white noise , ii) recorded mother's voice, iii) MiniMuffs, and iv) control. Masking could not be performed because the mother's voice was requested from the mothers.Masking could not be done because researchers and observers heard the mother's voice and white noise and saw the mimimuff.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: September 10, 2017
• Primary Completion: June 21, 2018
• Study Completion: April 13, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)