UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of music (Brahms lullaby) and a pacifier on heel lance in preterm infants A randomized controlled crossover trial
Title of the study (Brief title)	Effect of music (Brahms lullaby) and a pacifier on heel lance in preterm infants
Region	Japan

Condition
Condition	Premature Infant
Classification by specialty	Pediatrics Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate the alleviative effect of new pain management methods (Brahms lullaby, non-nutritive sucking, facilitated tucking and holding) on heel lance pain in preterm infants by the Premature Infant Pain Profile (PIPP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the Premature Infant Pain Profile (PIPP)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Intervention constituted of a Brahms lullaby with non-nutritive sucking, facilitated tucking and holding.
Interventions/Control_2	Standard care(control) constituted of facilitated tucking and holding, which is routine care in the NICU.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	32 weeks-old <=
Age-upper limit	35 weeks-old >=
Gender	Male and Female
Key inclusion criteria	(1) infants at 28 weeks Gestational age (GA) or more and less than 36 weeks GA, (2) infants at 32-35 weeks post conceptual age at the intervention, (3) Apger score of 6 or more at 5 minutes after birth, (4) intraventricular hemorrhage grade of 2 or less, (5) infants after 48 hours or more in e case of birth by cesarean operation, and infant with the permission of the doctor.
Key exclusion criteria	(1) a congenital anomaly or a serious condition, and (2) sedative or an analgesic drug usage within 48 hours before the heel lance. When an infant who had participated in the intervention showed an abnormal result on the automatic auditory brainstem response (AABR), the infant was removed from the data.
Target sample size	25

Research contact person
Name of lead principal investigator	Hiroko Uematsu
Organization	Takamatsu Red Cross Hospital Division of Nursing Science, Graduate School of Biomedical and Health Science, Hiroshima University
Division name	Department of Neonatal intensive care unit
Address	Bancho4-1-3, Takamatsu city, Kagawa prefecture, 760-0017
TEL	087-831-7101
Email	huematsu-tky@umin.ac.jp

Public contact
Name of contact person	Ikuko Sobue
Organization	Division of Nursing Science, Graduate School of Biomedical and Health Science, Hiroshima University
Division name	Pediatric nursing development studies
Address	Kasumi, Minami-ku, Hiroshima University, 734-8553
TEL	082-257-5370
Homepage URL
Email	sobue@hiroshima-u.ac.jp

Sponsor
Institute	Division of Nursing Science, Graduate School of Biomedical and Health Science, Hiroshima University
Institute
Department

Funding Source
Organization	Nursing grant in aid of Japan Red Cross Society
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	高松赤十字病院（香川県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 25 Day
Anticipated trial start date	2014 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 17 Day
Last modified on	2016 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028629