UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024876
Receipt No. R000028629
Scientific Title Effect of music (Brahms lullaby) and a pacifier on heel lance in preterm infants A randomized controlled crossover trial
Date of disclosure of the study information 2016/11/18
Last modified on 2016/11/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of music (Brahms lullaby) and a pacifier on heel lance in preterm infants

A randomized controlled crossover trial
Acronym Effect of music (Brahms lullaby) and a pacifier on heel lance in preterm infants

Scientific Title Effect of music (Brahms lullaby) and a pacifier on heel lance in preterm infants

A randomized controlled crossover trial
Scientific Title:Acronym 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
1st name
Middle name
Last name 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
Zip code
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
1st name
Middle name
Last name Ikuko Sobue
Organization Division of Nursing Science, Graduate School of Biomedical and Health Science, Hiroshima University
Division name Pediatric nursing development studies
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.