Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348316
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-30
Brief Title:
Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
The Effect of Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim In this prospective randomized controlled study it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression
Design The prospective randomized controlled study
Design The prospective randomized controlled study
Detailed Description:
The study will include n136 mothers who gave birth at term at Trakya University Health Research and Application Center Birth Service Between 10092023 and 10072024 n136 34control 34semi-swaddled 34kangaroo care 34semi-swaddled and kangaroo care women who volunteered to participate in the study will be conducted randomly in four groups case and control
Before starting the research four groups will be randomly formed among the mothers As a randomization method mothers who meet the sampling inclusion criteria determined in the research will be identified and listed Individuals to be taken into four groups will be determined by randomization method from the random numbers table httpwwwstattrekcomstatisticsrandomnumber-generatoraspx
Research data It was collected using the Survey Form Edinburgh Postpartum Depression Scale EPDS and Pittsburgh Sleep Quality Index PSQI
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 babys sleep pattern and the characteristics of the babys 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- Page 2 of 8 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 1213
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 and its validity and reliability study in Turkish was performed by Agargün et al 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
The survey form and scales will be applied to all four groups at the first meeting In the groups where half swaddle kangaroo care and both half swaddle and kangaroo care are applied necessary information about sleep such as the mothers sleep duration frequency of waking up duration of wakefulness and reasons for waking up will be recorded before the start of the study and for 24 hours During the 6 months of the study period mothers will be called every month by phone and their questions about the application methods and the application will be answered All scales will be repeated at the beginning 1st 3rd and 6th months and the mothers sleep monitoring for the last 24 hours will be requested again Practical training on semi-swaddle and kangaroo care will be provided to mothers at the first meeting through prepared presentations
Data collection The mean scores of PSQI and EPDS at the beginning1st 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 babys 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 babys breast was placed on the mothers 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 mothers 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
Before starting the research four groups will be randomly formed among the mothers As a randomization method mothers who meet the sampling inclusion criteria determined in the research will be identified and listed Individuals to be taken into four groups will be determined by randomization method from the random numbers table httpwwwstattrekcomstatisticsrandomnumber-generatoraspx
Research data It was collected using the Survey Form Edinburgh Postpartum Depression Scale EPDS and Pittsburgh Sleep Quality Index PSQI
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 babys sleep pattern and the characteristics of the babys 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- Page 2 of 8 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 1213
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 and its validity and reliability study in Turkish was performed by Agargün et al 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
The survey form and scales will be applied to all four groups at the first meeting In the groups where half swaddle kangaroo care and both half swaddle and kangaroo care are applied necessary information about sleep such as the mothers sleep duration frequency of waking up duration of wakefulness and reasons for waking up will be recorded before the start of the study and for 24 hours During the 6 months of the study period mothers will be called every month by phone and their questions about the application methods and the application will be answered All scales will be repeated at the beginning 1st 3rd and 6th months and the mothers sleep monitoring for the last 24 hours will be requested again Practical training on semi-swaddle and kangaroo care will be provided to mothers at the first meeting through prepared presentations
Data collection The mean scores of PSQI and EPDS at the beginning1st 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 babys 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 babys breast was placed on the mothers 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 mothers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None