We measure the effect of oral movement intervention of premature babies by the mother on their mood.
Design
The clinical trial has a control group, with parallel groups of a blind strain and is performed on 74 patients. Two hospitals are chosen by lottery for control and intervention groups.
Settings and conduct
Mothers of premature babies who meet the inclusion criteria fill out the questionnaire at the beginning of the study and 10 days later in the neonatal intensive care unit at Al-Zahra and 17 Shahrivar Hospitals in Rasht. In the intervention group, the intervention will be done by the mothers.
Participants/Inclusion and exclusion criteria
Entry criteria for mothers:
1) Not having a history of infertility-Uncomplicated pregnancy-Desire of pregnancy-No history of physical and mental illness- No addiction-The absence of accidents during the past three months (according to the participant's statement)
Exit criteria:
Mother's unwillingness to continue participating in the study_Early discharge of the baby with the personal consent of the parents_Transferring the baby to another treatment center_Not having the ability to intervene_incompleteness of 20% of the completed information of the forms
Intervention groups
Premature infant oromotor intervention is performed in premature babies to strengthen sucking and swallowing. which is done by the mother in the intervention group, and in the control group it is done by a nurse or speech therapist according to the ward routine.
Main outcome variables
Improving the mood of mothers
Increasing participation of mothers in care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230423057977N1
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
sahar Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4237 3421
Email address
s-hosseinzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Premature Infant Oromotor Intervention by mother on the situation of mood in mothers of premature infants
Public title
The effect of premature infant oral motor intervention by the mother on mothers' mood
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
For mothers, entry conditions include: no history of infertility
Uncomplicated pregnancy
Desire to be pregnant
No history of physical and mental illness
No addiction
Lack of accidents during the last three months (according to the participant)
The conditions for the inclusion of infants in the study include: 1) infants with a gestational age of 29-34 weeks, 2) having physiological stability and no stress symptoms at the time of stimulation, 3) without cleft palate, cleft lip, and temperament abnormalities, 4) infants with an Apgar score of 5 or more than 7
Exclusion criteria:
Mother's unwillingness to continue participating in the study
Early discharge of the baby with the personal consent of the parents
Transferring the baby to another treatment center
Not having the ability to intervene
Incompleteness of 20% of the completed information of the forms
The conditions for the exclusion of infants from the study: 1) sepsis 2) heart disease 3) necrotizing enterocolitis 4) grade 3 and 4 intraventricular hemorrhage (according to sonography that is routinely performed in the first week) 5) severe asphyxia
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Two hospitals of Al-Zahra and 17 of Shahrivar were selected by lottery to collect samples for the control and intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to prevent the exchange of information between the mothers of the two control and intervention groups, from the two hospitals of 17 Shahrivar and Al-Zahra Rasht, one control group and the other intervention group will be collected by lottery. The intervention group is selected from 17 Shahrivar Hospital in Rasht and the control group is selected from Al-Zahra Hospital.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group / Ethics Committee in Research Faculty of Nursing, Midwifery and Rehabilitation Facult
Street address
Dr. Mirkhani St (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.TUMS.FNM.REC.1402.002
Health conditions studied
1
Description of health condition studied
Mood
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mood score in POMS standard questionnaire
Timepoint
Measuring the mood score at the beginning of the study (before the intervention) and 10 days after the intervention
Method of measurement
Standard Mood Questionnaire (POMS)
Secondary outcomes
1
Description
Participation
Timepoint
The questionnaire will be filled at the beginning of the study and 10 days later.
Method of measurement
Questionnaire POMS
Intervention groups
1
Description
Intervention group: The mood questionnaire will be filled in at the beginning of the study by the mother, who both herself and her baby meet the inclusion criteria. And oral motor intervention of the premature baby is taught to the mother by the researcher on the doll and educational videos. Then, after appropriate feedback, this intervention will be performed by the mother on her baby under the supervision of the researcher and speech therapy for 10 days. And the mood questionnaire will be completed again by the mother after 10 days of intervention.
Category
Rehabilitation
2
Description
Control group: The mood questionnaire will be completed at the beginning of the study by mothers who both themselves and their babies meet the entry criteria. And 10 days later, this questionnaire is filled again by mothers. During these 10 days, the baby will be cared for according to the department's routine.