1. Home
  2. Approved trials
  3. » فارسی

Comparing the lilt voice of Quran with normal situation, silence, and lullaby music on physiological responses and behavioral measures of premature infant discharged from neonatal intensive care unit

Protocol summary

Summary
Objective: this research planed to compare the effects of holly Quran recitation, with normal situation, silence and lullaby music on physiological responses and behavioral measures of premature infants. ِِDesign: a double blind randomized controlled trial will conducted to compair the effects of holly Quran recitation, normal situation, silence, and lullaby music on preterm newborns. All preterm newborns will randomly allocated to either the experimental or control group. Procedure: 120 premature infants who have inclusion criteria of this study, will randomly allocated in four groups: holly Quran recitation, silence, lullaby music and control groups. They will be observed for four dependent variables; oxygen saturation levels, heart rate, respiration rate and behavioral state. Interventions include; 20 minutes Holly Quran recitation (verse 7-23 of Yusuf Quranic chapters, by Shahhat Mohammad Anvar sound) and lullaby music(good night little, the sound of the Islamic Republic of Iran Radio) that will played via headphone with volume range 50-60 dB. Headphone with no sound will be used for silence group. Any group will be observed for physiological responses and behavioral state from 10 minutes before to 30 minutes after intervention and recorded numerous at 5,10 minutes before and 5, 10, 15, 20, 25 and 30 minutes after beginning of intervention, will be used to analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110097746N1
Registration date: 2011-10-31, 1390/08/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-10-31, 1390/08/09
Registrant information
Name
Narges Eskandari
Name of organization / entity
Azad Islamic University, Khalkhal branch
Country
Iran (Islamic Republic of)
Phone
+98 25 1770 3301
Email address
eskandari.2008@yahoo.com
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-05-20, 1391/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the lilt voice of Quran with normal situation, silence, and lullaby music on physiological responses and behavioral measures of premature infant discharged from neonatal intensive care unit
Public title
Comparing the lilt voice of Quran with normal situation, silence, and lullaby music on physiological responses and behavioral measures of premature infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Gestational age 28 to 37 weeks 2- Appropriate-for-gestational-age (AGA) 3- APGAR scores from 7 to 10 at one and five minutes after birth 4- Hearing confirmed by OAE 5- Iranian neonate 6- Nutrition by mother milk 7- No current phototherapy 8- No morbidities such as congenital defects, intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), sepsis, acute lung disease or neonatal anemia and any acute illness 9- No undergoing mechanical ventilation 10- No receiving sedation medications such as Phenobarbital 11- No documentation of hyper responsiveness to the sound and 12- No history of maternal drug abuse, including alcohol or illegal substances. Only infants, who are clinically stable and physically able to tolerate the stimuli will be included. Exclusion criterias: signs of hyper responsiveness to the sound such as hiccup, facial grimace, finger splay, clenched fingers, crying, vomiting, and heart rate over 200; oxygen saturation lower than 80 and any need to handling.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Shahid Lavasani street
City
Qom
Postal code
Approval date
2011-10-02, 1390/07/10
Ethics committee reference number
34/12078/پ

Health conditions studied

1

Description of health condition studied
physiologic and behavioral state
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Oxygen saturation
Timepoint
Q 5 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Monitor

2

Description
Respiratory rate
Timepoint
Q 5 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Monitor

3

Description
Heart rate
Timepoint
Q 5 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Monitor

4

Description
Behavioral state
Timepoint
Q 5 minute from 10 minutes before intervention until 10 minutes after intervention
Method of measurement
Behavioral state instrument scale

Secondary outcomes

empty

Intervention groups

1

Description
4- Control group: natural situation: neonates in this group will recive no intervention and only will observed for dependent variables for 40 minutes
Category
Treatment - Other

2

Description
1- Holly Quran recitation group:the intervention in this group will include 20 minutes recitation of Yusuf Quranic chapters, verse 7-23, by Shahhat Mohammad Anvar sound that will played via headphone by volume range 50-60 dB
Category
Treatment - Other

3

Description
3- Silence gruop: headphone with no sound will placed on their ear for 20 minutes
Category
Treatment - Other

4

Description
2- Lullaby music group: lullaby music (good night little, the work of the Islamic Republic of Iran radio) include 20 minutes music, will played via headphone by volume range 50-60 dB for this group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Izadi Medical Center
Full name of responsible person
Street address
City
Qom

2

Recruitment center
Name of recruitment center
Hazrate Zahra Medical Center
Full name of responsible person
Street address
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Ms. Naiieri
Street address
Shahid Lavasani street
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Azad Islamic University, Khalkhal branch
Full name of responsible person
Narges Eskandari
Position
Senior lecturer
Other areas of specialty/work
Street address
Valieasr street
City
Khalkhal
Postal code
Phone
+98 25 1770 3301
Fax
Email
eskandari.2008@yahoo.com; narges.eskandari@iran.ir; narges.eskandari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Azad Islamic University, Khalkhal branch
Full name of responsible person
Narges Eskandari
Position
M.Sc in midwifery
Other areas of specialty/work
Street address
Number 98, 69th Aveniu, Talegani Street
City
Qom
Postal code
Phone
+98 25 1770 3301
Fax
Email
eskandari.2008@yahoo.com; narges.eskandari@iran.ir; narges.eskandari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Narges Eskandari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
eskandari.2008@yahoo.comnarges.eskandari@iran.irnarges.eskandari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...