Objective: To investigate the effect of Holy Quran on physiological indicators of pain caused by venipuncture on preterm infants in the NICU. Inclusion Criteria Consisting of: Newborn babies weighing 1500 to 2500 g, Gestational age at birth at 29 weeks and a maximum of 36 weeks and Needing to the Venipuncture. Exclusion criteria: Infants during the study of abnormal physiological responses such as heart rate greater than 200 or less than 80% reduction in blood oxygen saturation to show, Any problem in registration of physiological responses. In this double-blind study that both participants and researchers who will registrar signs are unaware from type of intervention, 48 infants were randomly assigned eligible in both test and control (Mode A control group and Mode B test group) will be. The test group consisted of Surah Yasin and verses 1-67 Quran recitation Surah Rahman Saad Al-Ghamdi master the sound will be play by MP3 Player with Headphones. Quran recitation will play 5 minutes before Venipuncture and will continue to 10 minutes after Venipuncture. signs registraration for each group 10 minutes before to 20 minutes after Venipuncture every 5 minutes for 30 minutes will be continue.All procedures were performed in the control group except Quran recitation. Expected outcomes include decreased heart rate and respiratory rate And increasing the percentage of arterial oxygen saturation.
General information
Acronym
The effect of holy Quran Recitation on venipuncture pain in premature infants
IRCT registration information
IRCT registration number:IRCT2014112320053N1
Registration date:2015-04-16, 1394/01/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-16, 1394/01/27
Registrant information
Name
Narges Majidipour
Name of organization / entity
Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4228 7439
Email address
majidipour.n@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Dezful University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-10-02, 1394/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Holy Quran Recitation on physiological indicators related to venipuncture pain on hospitalized premature infants in the NICU
Public title
The effect of Holy Quran Recitation on Venipuncture pain in preterm infants
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria Consist of: 1500 to 2500 grams of weight to be; Gestational age at birth At least 29 weeks and a maximum of 36 weeks; The auditory system is intact; Need to venipuncture.
Exclusion Criteria: Babies with abnormal physiological responses during the study Such as heart rate greater than 200 Or decrease in blood oxygen saturation less than 80% of the show; Any problems in registration of physiological responses; needs to any Medical or Nursing intervention, Including ventilator connected Or need to have sedative Or venipuncture is not done by once try.
Age
From 1 day old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Dezful University of Medical Sciences
Street address
Next The Police Department, Azadegan Blv, Dezful
City
Dezful
Postal code
6461653476
Approval date
2014-06-01, 1393/03/11
Ethics committee reference number
DUR-130
Health conditions studied
1
Description of health condition studied
Hospitalized premature infants in the NICU
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Respiration Rate
Timepoint
Ten and five minutes before, during venipuncture, five, ten, fifteen and twenty minutes after venipuncture
Method of measurement
Monitoring
2
Description
Heart Rate
Timepoint
Ten and five minutes before, during venipuncture, five, ten, fifteen and twenty minutes after venipuncture
Method of measurement
Monitoring
3
Description
O2 Saturation
Timepoint
Ten and five minutes before, during venipuncture, five, ten, fifteen and twenty minutes after venipuncture
Method of measurement
Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group holly Quran recitation consisted of Surah Yasin and verses 1 to 67 of Surah Arrahman with the voice of Professor Saad Al-Ghamdi using small headphones with 50 to 60 dB will be broadcast.
Category
Treatment - Other
2
Description
Control group: In the control group for adjusting for confounding headphones, the handset will be put for babies, but the audio will not broadcast it.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit of Dezful Large Hospital
Full name of responsible person
Narges Majidipour
Street address
No 134, Farhang 18 sharghi between honar 7 and 9, Farhang shahr
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Fereydoun Niroozad
Street address
Dezful University of Medical Scienses, Next The Police Department, Azadegan blv, Dezful
City
Dezful
Grant name
معاونت پژوهشی
Grant code / Reference number
DUR-130
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezful 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
Dezful University of Medical Sciences
Full name of responsible person
Narges Majidipour
Position
MS in Neonatal Intensive Care Nursing, Faculty member of Dezful University of Medical Sciences
Other areas of specialty/work
Street address
No 134, Farhang 18 Sharghi Between Honar 7 and 9, Farhang Shahr
City
Dezful
Postal code
6491853954
Phone
+98 64 1528 7231
Fax
Email
Majidipour.n@dums.ac.ir bmelika@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Narges Majidipour
Position
MS in Neonatal Intensive Care Nursing- Faculty member of Dezful University of Medical Sciences
Other areas of specialty/work
Street address
No 134, Farhang 18 Sharghi Between Honar 7 and 9, Farhang Shahr