Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05657886 |
Other study ID # |
2020/P0226 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 5, 2020 |
Est. completion date |
March 2, 2022 |
Study information
Verified date |
December 2022 |
Source |
Trakya University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Aim: The aim of this study is to investigate the effect of half swaddle and kangaroo care
practices initiated in the early period in preterm infants on breastfeeding, mother-infant
attachment, maternal sleep quality and postpartum depression.
Design: The prospective, randomized controlled study
Description:
The prospective, randomized controlled study was conducted on 160 mothers with premature
babies whose age were between 18 and 49 randomly divided into four groups as 40 case group,
40 half swaddle group, 40 kangaroo care group, 40 half swaddle and kangaroo care group at the
neonatal intensive care service and birth service of Trakya University Health Research and
Application Center between September 2020 and March 2022.
In order to determine the number of samples, in order to test the difference in the effect
size of 0.3326851 calculated between the groups based on the 1-month difference in the EPDS
scores in the study of Herizchi et al. (2017), with 5% margin of error and 95% power, a total
of n=40 from each group was used. It was calculated that the mothers who gave =160 preterm
births should be included in the study.
N=160 samples of preterm infants were randomized with the help of ASS 11 (NCSS, LLC.
Kaysville, Utah. www.ncss.com) computer program, HS group (n=40), KC group (n=40), HS+KC
group. (n=40) and control (n=40) groups.
Data were collected using Survey Form, Edinburgh Postpartum Depression Scale (EPDS),
Pittsburgh Sleep Quality Index (PSQI), Mother-to-Infant Bonding Scale (MIBS), Breastfeeding
Self-Efficacy Scale-Short Form (BSES-SF), Latch Breastfeeding Diagnosis Measurement Form,
Perception of Insufficient Milk Questionnaire (PIMQ). Data were evaluated using descriptive
analyses, Mann Whitney U, Kruskal Wallis Test, Friedman S Test, Spearmen Correlation,
multiple linear regression analysis.
Research data It was collected using the Survey Form, Edinburgh Postpartum Depression Scale
(EPDS), Pittsburgh Sleep Quality Index (PSQI), Mother-to-Infant Bonding Scale (MIBS),
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), Latch Breastfeeding Diagnosis
Measurement Form, Perception of Insufficient Milk Questionnaire (PIMQ).
Survey form; It which was prepared by the researchers by reviewing the literature consists of
5 main sections and a total of 82 questions, including the personal characteristics of the
mother who gave birth preterm, the characteristics of the birth and the baby, the
characteristics of sleep, the characteristics of the baby's sleep pattern, and the
characteristics of the baby's growth and development.
Edinburgh Postnatal Depression Scale (EPDS): The scale was developed by Cox and Holden
(1987). Adapted to Turkish by Engindeniz, Küey, and Kültür (1996). It is used to determine
the risk for depression in the postnatal period and to measure the level and change of
violence. It is a self-assessment scale. It is applied to postpartum women. It contains a
total of 10 questions and measures depression. It provides a four-point Likert type
measurement. The directive is at the beginning of the scale and subjects are asked to mark
the substance most relevant to their situation when filling in the subjects. The total score
of the scale is obtained by adding these item scores. As a result of the cut-off point scale
study conducted in Turkey and it has ben calculated as 12/13
Pittsburgh Sleep Quality Index (PSQI): PSQI is a self-reported screening and assessment
questionnaire that details information on the type and severity of sleep quality and
disorders within the last month. It was developed by Buysse et al. (20), and its validity and
reliability study in Turkish was performed by Agargün et al. (21). PUKI evaluates sleep
quality in the last month. 18 items and 7 components (subjective sleep quality, sleep
latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills,
daytime dysfunction) are included in the scoring. Each item is evaluated over 0-3 points and
the sum of 7 component points gives the total PUKI score. The total score ranges from 0 to
21, with higher scores indicating worsening sleep quality. A total PUKI score of ≤5 is
considered "good sleep", and >5 is considered "bad sleep".
Mother-to-Infant Bonding Scale (MIBS): MIBS was developed by Taylor et al.12. The MIBS is a
measurement tool that can be applied easily and quickly by the puerperal from the first day
of the postpartum period and that allows the mother to express her feelings for her baby.
This scale shows the relationship between the bond between mother and infant and the mother's
mood during the early postpartum period. The MIBS is a four-point Likert-type scale
consisting of eight items. Answers are scored between 0-3, the lowest score that can be
obtained from the scale is 0 and the highest score is 24. High scores indicate a problem with
mother-infant bonding. A Turkish validity and reliability study of the scale was conducted by
Karakulak and Alparslan.
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF): The BSES-SF was developed by Dennis
(1999). Later, the short form of the scale was developed by Dennis (2003) by reducing it. The
BSES-SF is a 14-item instrument developed to measure breastfeeding confidence. All the items
are preceded by the statement "I can always" and are anchored by a five-point Likert-type
scale, with 1 = not at all confident and 5 = always confident. All the items are presented
positively and the scores are summed up to produce a final score ranging from 14 to 70, with
the higher scores indicating better BSE. Turkish validity and reliability of the scale were
done by Tokat and Okumuş (2013).
Latch Breastfeeding Diagnosis Measurement Form: It is a measurement tool developed by Jensen
et al. (1994). The Turkish validity of the Latch Breastfeeding Diagnosis Measurement Form was
performed by Yenal and Okumus (2003). The Latch Breastfeeding Diagnosis Measurement Form
consists of the combination of the first letters of the English equivalent of the five
evaluation criteria and is listed as follows: L (Latch on breast), A (Audible swallowing), T
(Type of nipple), C (Comfort breast/nipple), H (Hold / Help). Each item in the scale is
evaluated between 0-2 points. The lowest 0 and the highest 10 points are obtained from the
scale. Total high score indicates the baby's sucking success.
Perception of Insufficient Milk Questionnaire (PIMQ): Designed based on the conceptual model
of McCarter-Spaulding and Kearney (2001), clinical experience, and literature, this
six-question questionnaire was designed to measure the perception of insufficient milk in
breastfeeding mothers. Turkish validity and reliability study was done by Gökçeoğlu. The
first question is a ''yes'' or ''no'' question about whether them other perceives her milk as
sufficient and other questions assess whether the mother perceives her milk as insufficient.
Mothers rated these questions between 0 and 10, with ''0" meaning that her milk is perceived
as completely insufficient, and ''10" meaning that her milk is perceived as completely
sufficient. The lowest and highest scores possible on the scale are 0 and 50, respectively.
The value of the total score indicates how high the score is and whether the perception of
the amount of milk is sufficient.
Data collection The mean scores of BSES-SF, IMPS, LATCH, MIAS, PSQI and EPDS at the
beginning, 1st, 2nd, 3rd and 6th months of the half swaddling and kangaroo care group
Intervention. Half swaddle: HS applied to a newborn baby makes the baby feel completely safe,
as if in the womb. After laying the soft fabric or baby blanket, it was placed in the supine
position. Half swaddling was done so as not to restrict the baby's arm and leg movements. HS
was performed 15 minutes before each sleep during the day until the 3rd month.
Kangaroo care: The application was applied at twice a day and for 60 min, every day for 6
months in a row. While the mothers were taken to the NICU and practiced at home prior to
kangaroo care, hand hygiene and breast care were provided within the scope of infection
prevention rules. During KC, the mother placed her baby between two breasts, and the baby's
breast was placed on the mother's breast in an upright position. During the application of
KC, a quiet, calm and suitable environment was created so that comfort of the baby and mother
would not be disturbed. The mother and baby are covered with a blanket. The ambient
temperature was 26 centigrade degrees during the kangaroo care. In the continuation of the KB
application, the mother was asked to breastfeed her baby. In order to prevent the risk of
aspiration of the baby after breastfeeding, the baby was placed in the left lateral position
so that the mother and the baby could lie down together. The application steps of the
mother's KC were observed by the researcher and the deficiencies, if any, were corrected by
discussing with the mother during / after the application.
Control group: The mothers in the control group were given routine care.