Comparison of the effect of reflexology and body massage on physiological parameters and bilirubin level in neonates under photo therapy
Design
Single blinded, randomized, parallel group trial with control group, without placebo, multi-centered.
Settings and conduct
This randomized clinical trial carried out on 51 neonates with jaundice in Imam Hossein Pediatric Medical Center, Goldis Hospital of Shahin Shahr and Asgarieh Hospital of Isfahan. Participants and data analyzer will not know allocation of samples to interventions and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no underlying, congenital and infectious diseases; term infants (gestational age equal to or greater than 35 weeks); birth weight over 2,500 grams; exclusive breastfeeding.
Exclusion criteria: infant parents' unwillingness to participate in the study.
Intervention groups
First intervention group: Intervention will performed in a quiet, bright room, on the bed, and in a position where the infant is lying back and quite relaxed. The researcher holds the baby's heel with his left hand and gently massage the area in each leg for 15 minutes (a total of 30 minutes for both legs) with his right hand. The intervention will done once a day and olive oil will be used to facilitate massage.
Second intervention group: In this group, massage begins with the touch of the lower extremity and from the ankle (except soles of the feet) to the knee and groin. The umbilical region will massaged rotatly. The chest and back will massaged with both hands.The baby's hands will massaged rotatly from the arm to the fingers. The palms, cheeks and lips are also gently massaged with the index finger. Massages for each infant will be once daily for 10-15 minutes.
Control group: This group did not receive any intervention.
Main outcome variables
Physiological parameters; bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N11
Registration date:2020-01-06, 1398/10/16
Registration timing:registered_while_recruiting
Last update:2020-01-06, 1398/10/16
Update count:0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of foot reflexology and body massage on physiological parameters and bilirubin levels in neonates under photo therapy
Public title
Comparison of the effect of reflexology and body massage on physiological parameters and bilirubin levels in neonates under photo therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying, congenital and infectious diseases
Term infants (gestational age equal to or greater than 35 weeks)
Birth weight over 2,500 grams
Exclusive breastfeeding
Exclusion criteria:
Infant parents' unwillingness to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were individually divided into three groups of first intervention (reflexology), second intervention (body massage) and control group using blocked randomization. In this study, dice will be considered as a randomization tool. For making sequences, "A" letter will be assigned to the first group, "B" letter will be assigned to the second group, and the "C" letter will be assigned to the third group. Participants will not know allocation of samples to interventions and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer will not know how individuals are assigned to the interventions and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.ARAKMU.REC.1398.200
Health conditions studied
1
Description of health condition studied
Jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Percentage of arterial oxygen saturation (O2 saturation)
Timepoint
Before intervention and one day after intervention
Method of measurement
cardio set ARDP 10 vital signs monitoring system (made in Iran)
2
Description
Heart rate
Timepoint
Before intervention and one day after intervention
Method of measurement
cardio set ARDP 10 vital signs monitoring system (made in Iran)
3
Description
Respiratory rate
Timepoint
Before intervention and one day after intervention
Method of measurement
hs43 chronometer (made in China).
Secondary outcomes
1
Description
Bilirubin level
Timepoint
Before intervention and one day after intervention
Method of measurement
Serum bilirubin (wrist venous blood sample) measured by photometry.
Intervention groups
1
Description
First intervention group: Intervention will performed in a quiet, bright room, on the bed, and in a position where the infant is lying back and quite relaxed. The researcher holds the baby's heel with his left hand and gently massage the area in each leg for 15 minutes (a total of 30 minutes for both legs) with his right hand. The intervention will done once a day and olive oil will be used to facilitate massage.
Category
Treatment - Other
2
Description
Second intervention group: In this group, massage begins with the touch of the lower extremity and from the ankle (except soles of the feet) to the knee and groin. The umbilical region will massaged rotatly . The chest and back will massaged with both hands.The baby's hands will massaged rotatly from the arm to the fingers. The palms, cheeks and lips are also gently massaged with the index finger. Massages for each infant will be once daily for 10-15 minutes.
Category
Treatment - Other
3
Description
Control group: routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Asgarieh Hospital
Full name of responsible person
Mohammadreza Shahnaser
Street address
Asgarieh St., Soroush St.
City
Isfahan
Province
Isfehan
Postal code
8199753966
Phone
+98 31 3225 0041
Email
info@askariehospital.com
2
Recruitment center
Name of recruitment center
Imam Hosseain Hospital
Full name of responsible person
Mehrdad Memarzadeh
Street address
Imam Hossein Hospital, Imam Khomeini St.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
3
Recruitment center
Name of recruitment center
Goldis Hospital
Full name of responsible person
Mohammad Ebne-hejazi
Street address
Goldis Hospital, Goldis Town
City
Shahin Shahr
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3526 0801
Email
goldis_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Jazayeri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
za.jazayeri48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Jazayeri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
za.jazayeri48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Jazayeri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
za.jazayeri48@gmail.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of data, such as information on the main outcome can be shared.
When the data will become available and for how long
12 months after the publishing of the results.
To whom data/document is available
Researchers in academic and scientific institutions.
Under which criteria data/document could be used
Scientific purposes.
From where data/document is obtainable
Zahra Jazayeri
za.jazayeri48@gmail.com
What processes are involved for a request to access data/document