UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024876 |
|---|---|
| Receipt number | 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 15:40:18 |
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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
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
sobue@hiroshima-u.ac.jp
Sponsor or person
Institute
Division of Nursing Science, Graduate School of Biomedical and Health Science, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028629
