Comparison of the effect of sole reflex massage and Yakson's touch on behavioral reactions and weighing of premature babies
Design
The samples will be randomly assigned to two intervention groups (foot reflex massage and Yakson touch) and a control group.
Settings and conduct
The researcher will start sampling by referring to Amirkabir Arak Hospital and Neonatal Special Care Department. Yakson touch (5 minutes of rest-5 minutes of gentle stroking-5 minutes of rest) and foot massage will be performed for 15 minutes each and twice a day (8 am and 8 pm). In a day, two massage sessions should be done up to 5 days. Every 5 days, the weight of the babies will be recorded by the nurse at the beginning of the morning shift. Behavioral reactions will be checked twice at 8 am before the intervention and at 8 pm after the intervention. all three groups receive routine treatment in the neonatal intensive care unit.Blinding is in the form of a blind. The statistician is blind.
Participants/Inclusion and exclusion criteria
Entre:
Babies with a gestational age of 26-34 weeks
Having a stable clinical and physiological condition in a hospitalized baby
Having a 5th minute Apgar score of 7 or higher
Birth weight 1500-2499 grams
No congenital abnormalities
Absence of the baby's mother's addiction to cigarettes and drugs
Feeding the baby only with breast milk
Failure to enter:
Having a medical condition prohibiting the implementation of Yaxon, such as an unstable clinical condition
Perform surgery
Parents' unwillingness to continue the intervention
Receiving painkillers to relieve the baby's pain in the last 24 hours
Intervention groups
foot reflexology massage - Yakson touch
Main outcome variables
Behavioral reaction score based on Anderson's behavioral reaction scoring system
Weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240729062579N1
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Leila Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3224 9246
Email address
l.rahimi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sole reflex massage and Yakson's touch on behavioral reactions and weighing of premature babies
Public title
The effect of sole reflex massage and Yakson's touch on the behavior and weight of premature babies
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Babies with a gestational age of 26-34 weeks
Having a stable clinical and physiological condition in a hospitalized baby
Having a 5th minute Apgar score of 7 or higher
Birth weight 1500-2499 grams
No congenital abnormalities
Absence of the baby's mother's addiction to cigarettes and drugs
Feeding the baby only with breast milk
Exclusion criteria:
Having a medical condition prohibiting the implementation of Yaxon, such as an unstable clinical condition
Perform surgery
Parents' unwillingness to continue the intervention
Receiving painkillers to relieve the baby's pain in the last 24 hours
Age
From 7 days old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
At first, sampling of hospitalized babies who meet the entry criteria will be done using the available method. Then, the samples will be randomly divided into two intervention groups (foot reflex massage and Yakson touch) and a control group. In order to make a simple randomization in allocating people to each of the groups under study, a coded list of hospitalized infants whose informed consent was obtained from their parents and who meet the criteria for entering the study was prepared and then entered into the SPSS software with a random selection command. People will be allocated in three groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done in a single-blind manner through a statistical analyst (statistical consultant). Patients will receive the intervention, and patients and nurses will be aware of the intervention performed on each group and the results, and the statistical analyst will be blind.
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
Sardasht-Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.ARAKMU.REC.1403.121
Health conditions studied
1
Description of health condition studied
Behavioral reactions and weighing of premature babies
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Behavioral reactions - Anderson Behavioral Reactions Scoring System (ABSS) will be used in this study. This scale determines the behavioral status of the baby based on regular observations of breathing, eye opening or closing, body and trunk activity, and crying intensity.
Timepoint
Twice a day - once before the intervention and again after the intervention
Method of measurement
The research assistant evaluates the behavioral reactions of the babies 2 minutes before the intervention and leaves the research environment and re-evaluates the reactions of the babies 2 minutes after the intervention.
2
Description
Baby's weight
Timepoint
Every day at 8 am after feeding and changing diapers and before the intervention for 5 days with a calibrated scale.
Method of measurement
Early in the morning using a baby digital scale - weight gain is presented as daily weight gain (g/day), cumulative weight gain (g) and growth rate (g/kg/day).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: foot reflex massage and Yakson touch - one person will be responsible for the intervention (researcher) and one person will be responsible for measuring the behavioral reactions and weighing the baby (ward nurse). In the foot reflexology intervention group, the researcher will gently massage the soles of the feet using gentle but firm pressure of the fingers and thumb. The combination of massage therapy in this study includes tactile and movement stimulation. The massage will be performed for 15 minutes and includes three periods of 5 minutes of tactile stimulation, followed by 5 minutes of motor stimulation and again 5 minutes of tactile stimulation.In a day, two massage sessions should be done up to 5 days. Massage pressure is adjusted to make the baby feel comfortable. The foot reflex massage intervention will be performed by a trained researcher under the same conditions and at a room temperature of 26 to 28 degrees Celsius twice a day (8 in the morning, 8 in the evening). Researcher Yakson's touch intervention in carrying out this intervention after wearing a clean He disinfects his hands and arms and then warms his hands with a warmer until the palms reach 34 degrees Celsius.In the next step, the researcher relaxes both arms and the muscles of both shoulders for one minute to concentrate the energy of the palms. In the last step, the researcher provides Yakson's touch to the premature baby. Yakson's touch will be performed for 15 minutes (according to the protocol). Foot reflex massage and Yakson's touch will be performed after the seventh day of hospitalization and the stabilization of the baby's physiological condition.
Category
Treatment - Other
2
Description
Control group - In the control group, only the usual nursing care of the newborn visa care department will be performed. The variables of the research will be measured in parallel with two intervention groups. The measurement of the behavioral reactions of the control group, like the two intervention groups, is done twice a day (8 in the morning and 8 in the evening) by the researcher's colleague.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Special Care Department of Amirkabir Hospital
Full name of responsible person
Leila Rahimi
Street address
Shahid Shiroudi
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
amirkabir-hospital@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Daud Hekmatpour
Street address
Sardasht - Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
l.rahimi@arakmu.ac
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
70
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
Leila Rahimi
Position
پرستار-کارشناسی ارشد پرستاری کودکان
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaee (malek)
City
Arak
Province
Markazi
Postal code
3813933431
Phone
+98 86 3224 9246
Email
l.rahimi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sardasht - Arak University of Medical Sciences - Faculty of Nursing
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
sajadimahbobeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Leila Rahimi
Position
Nurse - master's degree in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaee (Malek)
City
Arak
Province
Markazi
Postal code
3813933431
Phone
+98 86 3224 9246
Email
l.rahimi@arakmu.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
Information such as the score of behavioral reactions of newborns, weight and sex of newborns, gestational age, first and fifth minute APCAR, birth grade, parents' occupation, parents' education, mother's age. Information will be published without mentioning names and personal details.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only researchers working in academic and hospital institutions
Under which criteria data/document could be used
Under the condition of correct and ethical use in order to improve the care and refer to the information of this research and by preserving the rights of the researchers of this project
From where data/document is obtainable
Leila Rahimi
rahimileila27@gmail.com
What processes are involved for a request to access data/document
Send name and surname - field of study - university of study - reason for needing said information - type of requested data - only via email