Investigating the effect of massage based on Iranian medicine with almond oil on bilirubin in full-term and pre-term infants with hyperbilirubinemia referred to the phototherapy departments of Shiraz hospitals.
1. Determine and compare the demographic characteristics between term and preterm infants in the intervention and control group
2. Determine and compare the mean of serum bilirubin before massage between the intervention and control groups in full-term and preterm neonates
3. Determine and compare the mean of serum bilirubin changes between term and preterm infants in the intervention and control group
4. Determine and compare the changes in the number of phototherapy days in term and preterm infants in the intervention and control group
5. Determination of predictive variables, bilirubin index in term and premature neonates in the intervention and control group
Design
A non-blinded randomized clinical trial with the control group. In 160 neonates. The online software will use for randomization.
Settings and conduct
Along with the routine care in the intervention group, the mother will massage the Infant for 15 minutes with almond oil three times a day in the phototherapy departments of Shiraz University of Medical Sciences hospitals for three days. Usual care will be done for the control group.
Participants/Inclusion and exclusion criteria
Birth age over 34 weeks and referred to the phototherapy centers. hyperbilirubinemia and no other underlying conditions, absence of infection, receiving medication during the study, and lack of sensitivity to almond oil.
Intervention groups
The massage group -the control group
Main outcome variables
Serum bilirubin level
Number of phototherapy days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221204056708N1
Registration date:2022-12-22, 1401/10/01
Registration timing:prospective
Last update:2022-12-22, 1401/10/01
Update count:0
Registration date
2022-12-22, 1401/10/01
Registrant information
Name
Bahar Morshed-Behbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4251
Email address
morshe_b@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of massage based on Iranian medicine with almond oil on bilirubin in full-term and pre-term infants with hyperbilirubinemia referred to the phototherapy departments of Shiraz hospitals.
Public title
Investigating the effect of massage based on Iranian medicine on the level of bilirubin in newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Birth age over 34 weeks
Hyper bilirubin
Hospitalization in the photo therapy department
Exclusion criteria:
Underlying medical conditions
medicine consumption
sensitivity to almond oil
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the stratified permutation block method will assign neonates to two control and intervention groups in two subgroups. Based on the size of the sample and the number of groups, and considering the two subgroups to create the correct ratio of sample allocation to the blocks, eight blocks of 20 will be allocated in the random allocation list (according to the two subgroups, ten items per subgroup). We will prepare the random allocation list with online software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Schools of Nursing and Midwifery, Management and Medical Information - S
Street address
Karimkhan Zand Street, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.100
Health conditions studied
1
Description of health condition studied
Neonatal jaundice, unspecified
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Mean serum bilirubin level
Timepoint
Daily , from the time of admission until three days
Method of measurement
Venous blood sampling and measurement of bilirubin level
Secondary outcomes
1
Description
The number of photo therapy hours
Timepoint
Discharge time
Method of measurement
Photo therapy hours recorded in the file
Intervention groups
1
Description
Intervention group: Massage based on Iranian medicine with almond oil. We massage the neonates in 3 stages for 15 minutes. 5 minutes for each step. In the first step: We put the neonate on his abdomen. We will massage the neonate from the top of the head to the neck and upside down. Then back and forth movements from the neck to the shoulders. Then, from the upper back to the waist. Then we massage from the shoulder to the fingertips back and forth (on both hands). Then massage from the thigh to the ankle in a back-and-forth motion, which we do on both legs. In the second step, we put the baby to sleep in the open arch position. We perform bending and straightening movements of the right arm, left arm, right leg, and left leg (folded or flexed) in each step (opening and closing the hand or leg) movement in ten seconds, which together take one minute will be done. It will take about 5 minutes for both hands and both feet. In the third step, we will repeat the first step. These steps are taught to the mother to perform.
Category
Treatment - Other
2
Description
Control group: In this group, we perform only routine care, such as phototherapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zainab Hospital
Full name of responsible person
Bahar Morshed Behbahani
Street address
Namazi Sq
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 917 714 4766
Email
morshe_b@yahoo.com
2
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Bahar Morshed Behbahani
Street address
Namazi Sq
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 917 714 4766
Email
morshe_b@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Karimkhan Zand St
City
Shhiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Bahar Morshed-Behbahani
Position
Assistant Professor of Reproductive Health MPH of Health Policy
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4251
Fax
Email
morshe_b@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahar Morshed-Behbahani
Position
Assistant Professor of Reproductive Health MPH of Health Policy
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4251
Fax
Email
morshe_b@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahar Morshed-Behbahani
Position
Assistant Professor of Reproductive Health MPH of Health Policy
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4251
Fax
Email
morshe_b@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available