ClinicalTrials.gg
CompletedNCT06610656CLİNİCALUpdated Sep 24, 2024

White Noise and Pacifier Use on Postoperative Pain and Crying in Newborns

An interventional study of Pacifier and White Noise Therapy and pacifier therapy in Pain, sponsored by Yuksek Ihtisas University. Completed at 1 site in Turkey. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Yuksek Ihtisas University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Mar 2022, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Day to 28 Days
Sex
All
01

Study summary

The study was conducted to determine the effect of white noise and pacifier applications on pain and crying time during painful interventions in newborns who underwent surgery

Read the detailed description

Newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. This result implies that newborn or child pain should be adequately managed. Thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. Managing this pain in newborns should be one of the primary duties of newborn nurses. The first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. Many non-pharmacological methods are used to manage pain that may occur in interventional procedures. Some of these methods are: giving sugar solution, kangaroo care, positioning (Kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. Two other effective methods are non-nutritive suction and white noise. As a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. Within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. By examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

02

Conditions studied

  • Pain

Browse trials for

Keywords

  • white noise
  • pacifier
  • newborn
  • surgery
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 30 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Yuksek Ihtisas University is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Birth weight over 1500 grams

    • Having passed the newborn hearing screening test
    • Having a history of previous surgery (excluding brain surgeries)
    • Not using sedative substances (dormicum, fentanyl)
    • Not using opioids
    • Having a full stomach 30 minutes before painful interventions
    • Having permission from their mothers
    • Newborns undergoing blood transfusion only

Exclusion criteria

Exclusion Criteria:

  • Being intubated

    • Having hiberbilirubinemia
    • Birth weight below 1500 grams
    • Having cerebral palsy
    • Having hydrocephalus
    • Having spina bifida
    • Having had brain surgery
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    White noise and pacifier applications group

    In this group, infants will receive pacifier and white noise therapy. The white noise will be used to enhance the quality of sleep and reduce restlessness in infants. During the intervention, participants will receive pacifiers, and white noise will be continuously administered.

    Other: Pacifier and White Noise Therapy

  • Active comparator
    pacifier applications group

    In this group, infants will receive only pacifier therapy. The aim is to provide comfort and support for sleep through the use of pacifiers. White noise will not be utilized in this group. This intervention focuses solely on assessing the effects of pacifier use without any additional auditory stimuli

    Other: pacifier therapy

Interventions

  • OtherPacifier and White Noise Therapy

    Infants will receive both pacifier and white noise therapy to enhance sleep quality and reduce restlessness

  • Otherpacifier therapy

    Infants will receive pacifier therapy to enhance sleep quality and reduce restlessness

06

What researchers measure

Primary outcomes

  1. 1. Neonatal Pain Scale (NIPS

    The factors evaluated in the newborn baby pain scale are facial expression, arms, legs, oxygen saturation, arousal, breathing pattern, crying, heart rate. It can be preferred in post-operative pain. It can be used in procedural pain. It has a total of 8 parameters. The highest score can be given is 7. 0 points = no pain, 1-2 points = mild pain, 3-4 points = moderate pain, \>4 points = severe pain is accepted.

    Time frame: 20 minutes

07

Study locations

1 site
  • Yüksek Ihtisas Üniversity
    Ankara, Çankaya 62510, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Sep 2022, 6 months.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 6 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2024
First posted
Sep 24, 2024
StartActual
Mar 1, 2022
Primary completionActual
Sep 15, 2022
CompletionActual
Sep 15, 2022
Last update
Sep 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06610656
Lead sponsor
Yuksek Ihtisas University
Responsible party
Arzu Bahar (Associate Pofessor, Yuksek Ihtisas University) — Principal investigator
First posted
Sep 24, 2024
Start date
Mar 1, 2022
Primary completion
Sep 15, 2022
Completion
Sep 15, 2022
Last update
Sep 24, 2024

Study contacts

arzu bahar
principal investigator · Yüksek Ihtisas University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion