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IRCT20240729062579N1 IRCT 2024-08-05 Arak University of Medical Sciences The effect of sole reflex massage and Yakson's touch on the behavior and weight of premature babies Comparison of the effect of sole reflex massage and Yakson's touch on behavioral reactions and weighing of premature babies 2024-08-22 anticipated 61 Complete https://irct.ir/trial/78231 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Behavioral reactions and weighing of premature babies. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 access period starts 6 months after the results are published To whom: Only researchers working in academic and hospital institutions Conditions: 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 Where to obtain: Leila Rahimi rahimileila27@gmail.com How to obtain: Send name and surname - field of study - university of study - reason for needing said information - type of requested data - only via email Comments:
public Leila Rahimi
Shahid Rajaee (malek)
Arak Iran (Islamic Republic of) 3813933431 +98 86 3224 9246 l.rahimi@arakmu.ac.ir Arak University of Medical Sciences scientific Mahbobeh Sajadi
Sardasht - Arak University of Medical Sciences - Faculty of Nursing
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3524 sajadimahbobeh@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) 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 7 days 29 days Both 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 Treatment - Other Treatment - Other 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. 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. 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. 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). Arak University of Medical Sciences Approved 2024-06-29 Ethics Committee of Arak University of Medical Sciences Sardasht-Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)