Comparison effect of lullabies, Nurture voice, and White sound on pain during insert IV line in premature infants.
Design
Four-arm parallel-group randomized trial with blinded outcome assessment of 110 premature infants. Randomization was done by using a card drawing from the envelope without replacement.
Settings and conduct
Hospitalized premature babies will be placed in four groups A, B, C, and D based on 4 blocks. In all 3 intervention groups, a sound selected based on randomization will be played from 5 minutes before the start of the insertion line, through a microphone with a frequency of 45-60 dB, which is placed at a distance of 20 cm from the baby's head, until 5 minutes after its completion. In the control group, the IV line will be performed without listening to any sound. The infant's pain will be measured three times: before, during, 5 minutes after.
Participants/Inclusion and exclusion criteria
Not giving sedatives during intravenous line insertion and at least 3 hours before; Not to have an underlying disease and extensive surgeries that cause pain (such as abdominal surgeries, etc.); Not to have paralyzing diseases and anatomical defects of limbs (hands and feet); No hearing impairment screening test confirmation); Apgar above five in the fifth minute after birth;
The birth weight equal to or more than 1000 gr; Not having a chest tube; Having at least one experience of inserting an IV line
Intervention groups
The three intervening groups will listen to lullaby, nature sound, and white noise from 5 minutes before to 5 minutes after the end of the intravenous line placement. Control group: does not receive any intervention before, during, and after inserting the IV line.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N12
Registration date:2023-10-21, 1402/07/29
Registration timing:registered_while_recruiting
Last update:2023-10-21, 1402/07/29
Update count:0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of lullabies, Nurture voice and white voice on pain of during insert IV line in premature infants in neonatal intensive care unit
Public title
Comparison effect of lullabies, Nurture voice and white voice on pain of during insert IV line in premature infants in neonatal intensive care unit.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not receiving sedatives during intravenous line insertion and at least 3 hours before that
Apgar above five in the fifth minute after birth
Birth weight equal or more than 1000 gr
Exclusion criteria:
Diagnosis of hearing impairment (screening test confirmation)
The presence of an underlying disease and extensive surgeries that cause pain (such as abdominal surgeries, etc.)
Paralyzing diseases and anatomical defects of the limbs (hands and feet)
Age
From 28 days old to 32 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Make four blocks A-B-C-D by drawing a card by the first mother. In each card, different states of the block are specified and the researcher will place 4 babies in the specified group respectively. The above card is taken out of the pocket and the mother of the 5th baby again takes out a card from the envelope and the status of the next group of 4 babies will be determined.
Before inserting the IV line, during and 5 minutes after the completion of the inserting the IV line
Method of measurement
Neonatal Infant Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: listening to lullabies-lullabies will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention.
Category
N/A
2
Description
Intervention group sound of nature- It will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention.
Category
N/A
3
Description
Intervention group 3: the Wight Voice- It will be played using an MP3 player and two tiny microphones placed on both sides of the baby's head at 20 cm. The sound broadcast in this intervention group started when the baby was transferred to the cut room and the baby's condition stabilized (about 5 minutes), and it will continue for 5 minutes after the end of the intervention.
Category
N/A
4
Description
Control group: In the control group, the intravenous line was inserted according to the usual routine without any additional intervention, only based on the usual care in the ward, and the pain of the baby will be recorded using the same tools at the same times as the other three groups (5 minutes before, during and 5 minutes after).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem Hospital
Full name of responsible person
Dr. Nategh
Street address
ٍEnd of phaze3- Ekbatan Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4702 0000
Fax
+98 21 4467 0432
Email
site@sarem.org
Web page address
https://saremhospital.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza falak
Street address
Iran University of Medical sciences, hemat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Fax
+98 21 8670 2503
Email
falak.r@iums.ac.ir
Web page address
https://vcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
0098214351000
Fax
+98 21 8888 2886
Email
shoghimmahnaz@yahoo.com
Web page address
https://www.fnm.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
+98 21 8888 2886
Email
shoghimmahnaz@yahoo.com
Web page address
https://fnm.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
+98 21 8888 2886
Email
shoghi.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After Data coding in order to keep the confidentiality of the participants in the research
When the data will become available and for how long
The end of sampling till six months after the article publishing.
To whom data/document is available
Ethical, Reviewer and Editorial committees, Researchers.
Under which criteria data/document could be used
Systematic review and meta-analysis or secondary analysis citation
From where data/document is obtainable
Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir
What processes are involved for a request to access data/document
After sending a request to the academic email, we will send our data files for up to one week.