Investigating the effect of maternal body massage on infant pain due to invasive procedures in premature infants, neonatal intensive care unit
Design
A clinical trial with two intervention groups, massage and control group, without massage, examines the effect of massage by the mother on her infant during the hospitalization period. The intervention group and the control group are both under routine care and conventional therapies.
Settings and conduct
After receiving the approval of the ethics committee of Iran University of Medical Sciences and permission to attend the neonatal ward of Hazrat Ali Asghar Hospital
Participants/Inclusion and exclusion criteria
Admission requirements: It is possible for the mother to be present with the baby 24 hours a day, to feed the baby. Non-addiction of mothers to drugs and alcohol. The baby is the result of a twin. Permission for complete oral feeding of the infant through the mother's breast should be issued according to the doctor's instructions. Infants should have stable clinical conditions. Infants should not undergo phototherapy. At least 3 days have passed since the infant was admitted to the neonatal care unit. Massage the entire surface of the baby's body, not like having a chest tube or ventilator.
Intervention groups
This study is a clinical trial study. 42 infants with a gestational age of 29 to 37 weeks in the neonatal intensive care unit were selected by random sampling and randomly divided into two groups. In both groups, pain is measured before, during and after the intervention with the NIPS questionnaire.
be
Main outcome variables
pain
General information
Reason for update
Acronym
نوزادان نارس
IRCT registration information
IRCT registration number:IRCT20141216020344N4
Registration date:2021-03-10, 1399/12/20
Registration timing:prospective
Last update:2021-03-10, 1399/12/20
Update count:0
Registration date
2021-03-10, 1399/12/20
Registrant information
Name
Hamidreza Khoshnezhad Ebrahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 2189
Email address
khoshnezhad.hr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of maternal body massage on infant pain due to invasive procedures in premature infants, neonatal intensive care unit
Public title
Investigating the effect of maternal body massage on infant pain due to invasive procedures in premature infants, neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
It is possible for the mother to be with the baby 24 hours a day to feed the baby.
Non-addiction of mothers to drugs and alcohol
The baby is the result of a twin.
The weight of the baby at birth is 2500 grams and more
The gestational age of infants is 29 to 37 weeks
Permission for complete oral feeding of the infant through the mother's breast is issued according to the doctor's instructions.
Infants have stable clinical conditions
Babies should not be undergoing phototherapy.
- At least 3 days have passed since the baby was admitted to the neonatal care unit
The baby should not be attached to equipment that prevents massaging of the baby's entire body, such as a chest tube or ventilator
Exclusion criteria:
Discharge of the infant before the end of the intervention
Disruption of stability and general conditions of mother and baby
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method will initially be done randomly using the table of random numbers in the statistical reference book. The first choice from the table of even random numbers will be the sampling of the control group. Sampling in the control and test groups will be done by systematic randomization; In this way, according to the time specified in Jules Gantt for sampling, which is estimated to be 90 days (3 months), and also after reviewing and calculating the approximate number of admissions in the hospital, the number of samples that the conditions and The inclusion criteria for the present study are estimated to be one infant per day (approximately 90 eligible infants will be admitted to the hospital within 90 days). To get 21 samples in each group, divide 90 by 21 and it is approximately equal to 4. In this way, from the day of sampling, the first, fourth, eighth, twelfth and .... (multiple of 4) who are admitted to the hospital will be selected for sampling to achieve the required number of samples. (These numbers will be observed in sampling of both control and test groups
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
Ethics Committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-01-12, 1399/10/23
Ethics committee reference number
IR.IUMS.REC.1399.1121
Health conditions studied
1
Description of health condition studied
premature infants
ICD-10 code
P07.30
ICD-10 code description
Preterm newborn, unspecified weeks of gestation
Primary outcomes
1
Description
pain
Timepoint
Before, during and after the intervention
Method of measurement
Neonatal Infant Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, a booklet with an educational CD about massage training prepared by the Department of Neonatal Health is given to mothers. (Massage from head to toe while the baby's body is uncovered or only has diapers). Massage training video for mothers is shown by the researcher. Massage training classes are held in the conference hall of the hospital. All health protocols are observed. Before rushing to class, their vital signs are checked and they are asked about the history of contact with a person with coronary artery, and gloves and masks are provided to them, and the class is performed individually. The training sessions are performed in 2 one-hour sessions. The mothers practiced the massage on the model in the presence of the researcher, through face-to-face training, if the mother needed more sessions and hours to train. It will continue until he learns to massage properly. Proper performance of massage The fact that all mothers have a correct understanding of massage training is controlled by the researcher by observing the massage performed by mothers on the replica. In all stages of film distribution to teach massage, and practical massage practice, the researcher will be present to provide more explanations and solve the problems and questions of mothers. The first massage of the baby was done by the mother, with the presence of the researcher.In the intervention group massage for 5 days by mothers conducted in the procedure (venipuncture) pain is done, during and after the procedure will be calculated according to NIPS tool.
Category
N/A
2
Description
Control group: In the neonatal control group, they do not receive any intervention other than routine care, and the pain score before, during and after the procedure will be calculated according to the NIPS instrument.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Ali Asghar Hospital in Tehran
Full name of responsible person
Dr. Hamidreza Khoshnezhad Ebrahimi
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Fax
Email
Khoshnezhad.hr@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@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
Dr.Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@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
Data is encrypted in order to make the identities of individuals unidentifiable and confidential
When the data will become available and for how long
From the end of sampling to 6 months after the publication of the article
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
Perform systematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr. Hamidreza Khoshnezhad Ebrahimi
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide information files to individuals within a maximum of one week