NCT06120062 is a clinical trial of swaddled in Infant, Newborn, sponsored by Zonguldak Bulent Ecevit University.

Who is sponsoring NCT06120062?

NCT06120062 is sponsored by Zonguldak Bulent Ecevit University.

What drugs are being tested in NCT06120062?

Interventions in NCT06120062: swaddled, mother's breast milk odor, both swaddled and made to inhale mother's breast milk odor, No procedure.

What condition does NCT06120062 study?

NCT06120062 studies Infant, Newborn, Pain Perception.

Is NCT06120062 still recruiting?

NCT06120062 is currently completed. Last updated 7 November 2023.

Last reviewed 2023-11-07 · How we verify

NCT06120062

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort

Completed Last updated 7 November 2023

What this trial tests

trial testing swaddled in Infant, Newborn in 120 participants. Completed in 13 January 2023.

Timeline

1 October 2020

Primary endpoint
1 October 2021

13 January 2023

Quick facts

Lead sponsor	Zonguldak Bulent Ecevit University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	1 October 2020
Primary completion	1 October 2021
Estimated completion	13 January 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

swaddled
mother's breast milk odor
both swaddled and made to inhale mother's breast milk odor
No procedure

Conditions studied

Infant, Newborn — all drugs for Infant, Newborn →
Pain Perception — all drugs for Pain Perception →

Sponsor

Zonguldak Bulent Ecevit University

Who can join

Adults 1 Day to 27 Days, any sex, with Infant, Newborn or Pain Perception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized controlled experimental study was conducted to determine the effect of swaddling and inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter in term infants.The population of the study consisted of term infants hospitalized in the neonatal intensive care unit of Karadeniz Ereğli State Hospital between 1st October 2020 and 1st October 2021. According to the G-Power analysis, the sample size was calculated as 120 and term infants were equally assigned to three experimental groups and a control group, each of which consisted of 30 infants. During the placement of peripheral intravenous catheter, the infants in the 1st experimental group were swaddled, the infants in the 2ndexperimentalgroup were made to inhale the mother's breast milk odour, the infants in the 3rd experimental group were both swaddled and made to inhale the mother's breast milk odour and no procedure was applied to the infants in the control group. The pain and comfort levels of infants in the experimental and control groups were assessed before, during and after the placement of peripheral intravenous catheter. "Infant Descriptive Information Form", "Neonatal Infant Pain Scale (NIPS)" and "Neonatal Comfort Behaviour Scale (NCBS) were used to collect data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Infant, Newborn

Currently open trials in the same condition.

NCT07302412 — Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia · NA · recruiting
NCT07212361 — Infant Microbiota Restoration With Maternal Microbes · NA · recruiting
NCT06757543 — A Stepped Wedge Cluster Randomised Trial of Video Versus Direct Laryngoscopy for Intubation of Newborn Infants · NA · recruiting
NCT06750796 — The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression · NA · recruiting
NCT06803498 — Delivery Room Intervention and Evaluation Network · recruiting

Other Zonguldak Bulent Ecevit University trials

Trials by the same sponsor.

NCT07235735 — The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers · NA · not yet recruiting
NCT07246720 — IPP-PSP Block vs. SPSIPB in Breast Surgery · NA · not yet recruiting
NCT07585903 — The Effect of Family-Centered Care Practices In Pediatric Intensive Care Unit · NA · completed
NCT07382895 — The Relationship Between the ASA Score Determined by Operating Room Nurses and Intubation Duration · completed
NCT06948383 — SPSIPB vs. SAPB in Breast Surgery · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06120062 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zonguldak Bulent Ecevit University
Last refreshed: 7 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06120062.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing