Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197100
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-26
Brief Title:
Supportive Care Training Given to Mothers of Babies With Infants Colic
Sponsor:
Kirsehir Ahi Evran Universitesi
Organization:
Kirsehir Ahi Evran Universitesi
Study Overview
Official Title:
Effectiveness of Supportive Care Training Given to Mothers of Babies With Infant Colic Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life It has a prevalence of 15-30 and is defined by excessive sobbing for at least 3 hours per day 3 days per week for around 3 weeks
Excessive sobbing blushing parachroma around the lips bloating in the abdomen drawing the legs into the abdomen coldness at the ends and fisting of the hands are all symptoms of infantile colic Another significant clinical aspect of Infantile Colic is its protracted difficult to soothe and inexplicable nature Infantile Colic is thought to have a cicadian pain cycle that begins in the evening
Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life It has a prevalence of 15-30 and is defined by excessive sobbing for at least 3 hours per day 3 days per week for around 3 weeks
Excessive sobbing blushing parachroma around the lips bloating in the abdomen drawing the legs into the abdomen coldness at the ends and fisting of the hands are all symptoms of infantile colic Another significant clinical aspect of Infantile Colic is its protracted difficult to soothe and inexplicable nature Infantile Colic is thought to have a cicadian pain cycle that begins in the evening
Anxiety and stress that arise during the postpartum period cause a variety of issues in both the mother and the baby and have a negative impact on the mother-baby bond as well as the mothers care and parenting skills Sleep deprivation sleep disturbance and exhaustion are said to be caused by the sensation of not being able to meet the childs demands It has been found that as parental stress levels rise the gut flora deteriorates and increasing cortisol in breast milk increases the babys crying attacks Colic and excessive crying are also risk factors for unfavorable parent-infant interactions Infantile Colic has been shown to have a negative impact on childrens health in the short and long term for all of these reasons As a result healthcare experts must devise therapies to lessen the painful impact of Infantile Colic on babies and their families As a result the purpose of this study was to see how supportive care training for parents affected the colic levels of babies with Infantile Colic as well as mothers perceptions of nursing and parental self-efficacy
Excessive sobbing blushing parachroma around the lips bloating in the abdomen drawing the legs into the abdomen coldness at the ends and fisting of the hands are all symptoms of infantile colic Another significant clinical aspect of Infantile Colic is its protracted difficult to soothe and inexplicable nature Infantile Colic is thought to have a cicadian pain cycle that begins in the evening
Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life It has a prevalence of 15-30 and is defined by excessive sobbing for at least 3 hours per day 3 days per week for around 3 weeks
Excessive sobbing blushing parachroma around the lips bloating in the abdomen drawing the legs into the abdomen coldness at the ends and fisting of the hands are all symptoms of infantile colic Another significant clinical aspect of Infantile Colic is its protracted difficult to soothe and inexplicable nature Infantile Colic is thought to have a cicadian pain cycle that begins in the evening
Anxiety and stress that arise during the postpartum period cause a variety of issues in both the mother and the baby and have a negative impact on the mother-baby bond as well as the mothers care and parenting skills Sleep deprivation sleep disturbance and exhaustion are said to be caused by the sensation of not being able to meet the childs demands It has been found that as parental stress levels rise the gut flora deteriorates and increasing cortisol in breast milk increases the babys crying attacks Colic and excessive crying are also risk factors for unfavorable parent-infant interactions Infantile Colic has been shown to have a negative impact on childrens health in the short and long term for all of these reasons As a result healthcare experts must devise therapies to lessen the painful impact of Infantile Colic on babies and their families As a result the purpose of this study was to see how supportive care training for parents affected the colic levels of babies with Infantile Colic as well as mothers perceptions of nursing and parental self-efficacy
Detailed Description:
Research hypotheses Supportive care training for mothers of babies with infantile colic H1 Has an effect on the average nursing self-efficacy scores of moms of newborns with infantile colic
H2 It affects the parental self-efficacy score averages of moms of infantile colic kids H3 It influences the colic scores of infantile colic babies
MATERIALS AND METHODS Type of Research Research It was planned as a pretest-posttest randomized controlled experimental study
Purpose of the research Research It was planned to determine the effect of the educational supportive care program for parents on the colic levels of babies with Infantile Colic the parenting self-efficacy of mothers and the level of mother-infant attachment
Place and Characteristics of the Research It will be held at the Pediatrics Polyclinic of Kırşehir Ahi Evran University Training and Research Hospital There are 6 specialist physicians working in the pediatric outpatient clinic
At the hospital where the research will be conducted the pediatrician performs a detailed history and physical examination to diagnose infantile colic and identify symptomatic findings It questions when the crying spells start during the day tracking the duration of crying and the babys behavior During a complete physical examination the babys weight gain nutrition defecation pattern fever and illness are questioned and monitored Factors that may affect the babys infantile colic status such as the babys diarrhea eczema cows milk protein allergy lactose intolerance and mothers smoking are questioned In addition other problems and diseases in the babys intestines are also questioned After the history and physical examination are completed by the pediatrician the baby is diagnosed with infantile colic according to the Rome IV diagnostic criteria
Design and Blinding This prospective randomized controlled study is planned to be carried out at Kırşehir Ahi Evran University Training and Research Hospital Pediatrics outpatient clinic between March 2024- August 2024 The study will be conducted based on the CONSORT protocol
The study population will consist of 1-3 month old babies and their mothers who applied to the Pediatrics outpatient clinic with complaints of restlessness and crying between marc March 2024- August 2024 and were diagnosed with Infantile Colic by the physician and who meet the research criteria and are selected by randomization Similar studies were taken into account for the sample of the study Then a power analysis will be performed by a statistician using the GPower program Thus the number of samples to be taken into the experimental and control groups will be determined
Babies and mothers who meet the inclusion criteria will be randomly assigned to experimental and control groups through the online program httpwwwrandomizerorg
Blinding in the study included the parents of the babies included in the study a pediatrician from the researchers and a specialist nurse The first researcher who only implements the supportive education program is not blind so the pre-test post-test evaluation of the study will be collected independently by the second researcher a specialist nurse Additionally the evaluation will be analyzed by an independent statistician Therefore the current study will be conducted as a double-blind randomized controlled trial
Research Inclusion Criteria
Gestational week 37 birth weight 2500g
No congenital anomalies related to the digestive system or nutrition
Postnatal age of 1-3 months
Not receiving colic treatment
Diagnosed with Infantile colic by a pediatrician
Babies who are exclusively breastfed
Mothers of these babies who are over 18 years old do not use sedative or antiepileptic drugs can understand and communicate in Turkish have no mental disabilities and volunteer to participate in the study will be included in the research
Research Exclusion Criteria Babies whose gestational week is 37 and birth weight 2500g who have metabolic diseases and congenital anomalies of the digestive system who are being treated for colic who are not breastfed whose postnatal age is less than 1 month and more than 3 months and who are under 18 years of age who do not take antibiotics sedatives or Mothers who use an antiepileptic type of medication have communication problems and mental disabilities and who do not consent to the research will not be included in the study
Experimental Control Group Matching Criteria of the Research In randomized controlled studies the number of participants in the groups is expected to be equal or balanced as well as to be similar in terms of prognostic factors Therefore mothers in the experimental and control groups Babies will be selected similar in terms of age gender educational status marital status and number criteria and babies will be selected in terms of birth week and birth weight Stratified randomization will be performed in the study according to these criteria
Data Collection Tools Data of the research It will be collected by face-to-face interview with the parent using the Child and Parent Introduction Form Breastfeeding Self-Efficacy Scale and Perceived Maternal Parenting Self-Efficacy Scale
Child and Parent Identification Form This form consists of 4 questions regarding the mothers age education level medications used and the babys birth date
Breastfeeding Self-Efficacy Scale It is a scale consisting of 33 items developed by Dennis 1999 It consists of two sub-dimensions to determine mothers breastfeeding skills beliefs and behaviors regarding breastfeeding The validity and reliability study of the Turkish form of the scale was conducted by Ekşioğlu and Çeber
Technical sub-dimension It is aimed at determining the mothers breastfeeding skills such as being able to place the baby on the breast giving appropriate positioning recognizing the signs of good breastfeeding and weaning the baby from the breast
Sub-dimension related to personal thoughts It consists of items including the mothers willingness to feed her baby with breast milk her belief that she will have milk not using formula or bottle and her beliefs and behaviors regarding coping with breastfeeding difficulties
The scale prepared as a five-point Likert type I never trust myself I dont trust myself very much I sometimes trust myself I trust myself most of the time I always trust myself As the total score on the scale increases breastfeeding self-efficacy also increases The lowest score is 33 and the highest score is 165
Perceived Mother Parenting Self-Efficacy Scale It was developed by Barnes and Adamson-Macedo in 2007 to determine the self-efficacy levels of women who gave birth prematurely The scale is designed as a four-category scale type It is an 18-item scale consisting of positive items such as strongly disagree 1 disagree 2 agree 3 strongly agree 4 The validity and reliability study of the scale in Turkey was conducted by Verici and Kavlak in 2021 The Cronbach alpha coefficient examined for the internal consistency reliability of the scale was found to be 0943 A minimum of 18 points and a maximum of 72 points are obtained from the Perceived Mother Parenting Self-Efficacy Scale An increase in the score obtained indicates that the mothers self-efficacy level increases
Infant Colic Scale Appendix-4 The Infant Colic Scale was developed in 2002 by Marsha L Cirgin Ellet and her colleagues to assist healthcare professionals in diagnosing and evaluating colic The scale consists of 5 sub-dimensions and 22 questions Cows milksoy protein allergyintolerance immature digestive system immature central nervous system difficult baby parent-infant interaction problematic baby The Cronbach alpha coefficient of the scale was found to be 073
The validity and reliability study of the scale in Turkey was conducted by Çetinkaya and Başbakkal in 2006 The Cronbach alpha coefficient examined for the internal consistency reliability of the scale was found to be 073 16 The items of the infant colic scale were evaluated on a 6-point Likert scale Scale items were rated with Likert-type scoring ranging from 1 to 6 The rating was made from 1 strongly disagree to 6 strongly agree Negative questions were reverse coded for consistency in interpretation of scores Item 3 in the immature digestive system sub-dimension items 7 8 9 in the immature central nervous system sub-dimension items 13 14 15 in the difficult baby sub-dimension item in the parent-infant interactionproblem baby sub-dimension Items 17 and 19 were reverse coded A low mean score from the scale indicates that colic has decreased while a high mean score indicates that colic has increased
Pre-Application A preliminary application will be made with a total of 10 mothers who are not included in the study sample and the clarity and functionality of the data collection tools will be evaluated After the preliminary application necessary corrections will be made to the data collection tools
APPLICATION Study data will be collected between February 2022 and June 2023 The study group training group or control group to which the mothers of infants with infantile colic will be included will be determined by computer using a simple random sampling method The pre-test of the study will be administered to the experimental and control groups with the Child and Parent Introductory Form Breastfeeding Self-Efficacy Scale and Perceived Mother Parenting Self-Efficacy Scale before the intervention and the post-test will be administered immediately and 1 week after the intervention ends
Supportive care training will be given to the experimental group Training group In addition the booklet prepared by the researchers for the training will be given to the mothers The supportive care training intervention to be applied to the experimental group is planned to be implemented in 3 modules for 1 week Interventions will be carried out by the first investigator a specialist pediatric nurse Information regarding supportive care training is included in the appendix
Mothers in the control group will be given an educational brochure containing information on mother-baby nutrition and comforting the baby when crying
H2 It affects the parental self-efficacy score averages of moms of infantile colic kids H3 It influences the colic scores of infantile colic babies
MATERIALS AND METHODS Type of Research Research It was planned as a pretest-posttest randomized controlled experimental study
Purpose of the research Research It was planned to determine the effect of the educational supportive care program for parents on the colic levels of babies with Infantile Colic the parenting self-efficacy of mothers and the level of mother-infant attachment
Place and Characteristics of the Research It will be held at the Pediatrics Polyclinic of Kırşehir Ahi Evran University Training and Research Hospital There are 6 specialist physicians working in the pediatric outpatient clinic
At the hospital where the research will be conducted the pediatrician performs a detailed history and physical examination to diagnose infantile colic and identify symptomatic findings It questions when the crying spells start during the day tracking the duration of crying and the babys behavior During a complete physical examination the babys weight gain nutrition defecation pattern fever and illness are questioned and monitored Factors that may affect the babys infantile colic status such as the babys diarrhea eczema cows milk protein allergy lactose intolerance and mothers smoking are questioned In addition other problems and diseases in the babys intestines are also questioned After the history and physical examination are completed by the pediatrician the baby is diagnosed with infantile colic according to the Rome IV diagnostic criteria
Design and Blinding This prospective randomized controlled study is planned to be carried out at Kırşehir Ahi Evran University Training and Research Hospital Pediatrics outpatient clinic between March 2024- August 2024 The study will be conducted based on the CONSORT protocol
The study population will consist of 1-3 month old babies and their mothers who applied to the Pediatrics outpatient clinic with complaints of restlessness and crying between marc March 2024- August 2024 and were diagnosed with Infantile Colic by the physician and who meet the research criteria and are selected by randomization Similar studies were taken into account for the sample of the study Then a power analysis will be performed by a statistician using the GPower program Thus the number of samples to be taken into the experimental and control groups will be determined
Babies and mothers who meet the inclusion criteria will be randomly assigned to experimental and control groups through the online program httpwwwrandomizerorg
Blinding in the study included the parents of the babies included in the study a pediatrician from the researchers and a specialist nurse The first researcher who only implements the supportive education program is not blind so the pre-test post-test evaluation of the study will be collected independently by the second researcher a specialist nurse Additionally the evaluation will be analyzed by an independent statistician Therefore the current study will be conducted as a double-blind randomized controlled trial
Research Inclusion Criteria
Gestational week 37 birth weight 2500g
No congenital anomalies related to the digestive system or nutrition
Postnatal age of 1-3 months
Not receiving colic treatment
Diagnosed with Infantile colic by a pediatrician
Babies who are exclusively breastfed
Mothers of these babies who are over 18 years old do not use sedative or antiepileptic drugs can understand and communicate in Turkish have no mental disabilities and volunteer to participate in the study will be included in the research
Research Exclusion Criteria Babies whose gestational week is 37 and birth weight 2500g who have metabolic diseases and congenital anomalies of the digestive system who are being treated for colic who are not breastfed whose postnatal age is less than 1 month and more than 3 months and who are under 18 years of age who do not take antibiotics sedatives or Mothers who use an antiepileptic type of medication have communication problems and mental disabilities and who do not consent to the research will not be included in the study
Experimental Control Group Matching Criteria of the Research In randomized controlled studies the number of participants in the groups is expected to be equal or balanced as well as to be similar in terms of prognostic factors Therefore mothers in the experimental and control groups Babies will be selected similar in terms of age gender educational status marital status and number criteria and babies will be selected in terms of birth week and birth weight Stratified randomization will be performed in the study according to these criteria
Data Collection Tools Data of the research It will be collected by face-to-face interview with the parent using the Child and Parent Introduction Form Breastfeeding Self-Efficacy Scale and Perceived Maternal Parenting Self-Efficacy Scale
Child and Parent Identification Form This form consists of 4 questions regarding the mothers age education level medications used and the babys birth date
Breastfeeding Self-Efficacy Scale It is a scale consisting of 33 items developed by Dennis 1999 It consists of two sub-dimensions to determine mothers breastfeeding skills beliefs and behaviors regarding breastfeeding The validity and reliability study of the Turkish form of the scale was conducted by Ekşioğlu and Çeber
Technical sub-dimension It is aimed at determining the mothers breastfeeding skills such as being able to place the baby on the breast giving appropriate positioning recognizing the signs of good breastfeeding and weaning the baby from the breast
Sub-dimension related to personal thoughts It consists of items including the mothers willingness to feed her baby with breast milk her belief that she will have milk not using formula or bottle and her beliefs and behaviors regarding coping with breastfeeding difficulties
The scale prepared as a five-point Likert type I never trust myself I dont trust myself very much I sometimes trust myself I trust myself most of the time I always trust myself As the total score on the scale increases breastfeeding self-efficacy also increases The lowest score is 33 and the highest score is 165
Perceived Mother Parenting Self-Efficacy Scale It was developed by Barnes and Adamson-Macedo in 2007 to determine the self-efficacy levels of women who gave birth prematurely The scale is designed as a four-category scale type It is an 18-item scale consisting of positive items such as strongly disagree 1 disagree 2 agree 3 strongly agree 4 The validity and reliability study of the scale in Turkey was conducted by Verici and Kavlak in 2021 The Cronbach alpha coefficient examined for the internal consistency reliability of the scale was found to be 0943 A minimum of 18 points and a maximum of 72 points are obtained from the Perceived Mother Parenting Self-Efficacy Scale An increase in the score obtained indicates that the mothers self-efficacy level increases
Infant Colic Scale Appendix-4 The Infant Colic Scale was developed in 2002 by Marsha L Cirgin Ellet and her colleagues to assist healthcare professionals in diagnosing and evaluating colic The scale consists of 5 sub-dimensions and 22 questions Cows milksoy protein allergyintolerance immature digestive system immature central nervous system difficult baby parent-infant interaction problematic baby The Cronbach alpha coefficient of the scale was found to be 073
The validity and reliability study of the scale in Turkey was conducted by Çetinkaya and Başbakkal in 2006 The Cronbach alpha coefficient examined for the internal consistency reliability of the scale was found to be 073 16 The items of the infant colic scale were evaluated on a 6-point Likert scale Scale items were rated with Likert-type scoring ranging from 1 to 6 The rating was made from 1 strongly disagree to 6 strongly agree Negative questions were reverse coded for consistency in interpretation of scores Item 3 in the immature digestive system sub-dimension items 7 8 9 in the immature central nervous system sub-dimension items 13 14 15 in the difficult baby sub-dimension item in the parent-infant interactionproblem baby sub-dimension Items 17 and 19 were reverse coded A low mean score from the scale indicates that colic has decreased while a high mean score indicates that colic has increased
Pre-Application A preliminary application will be made with a total of 10 mothers who are not included in the study sample and the clarity and functionality of the data collection tools will be evaluated After the preliminary application necessary corrections will be made to the data collection tools
APPLICATION Study data will be collected between February 2022 and June 2023 The study group training group or control group to which the mothers of infants with infantile colic will be included will be determined by computer using a simple random sampling method The pre-test of the study will be administered to the experimental and control groups with the Child and Parent Introductory Form Breastfeeding Self-Efficacy Scale and Perceived Mother Parenting Self-Efficacy Scale before the intervention and the post-test will be administered immediately and 1 week after the intervention ends
Supportive care training will be given to the experimental group Training group In addition the booklet prepared by the researchers for the training will be given to the mothers The supportive care training intervention to be applied to the experimental group is planned to be implemented in 3 modules for 1 week Interventions will be carried out by the first investigator a specialist pediatric nurse Information regarding supportive care training is included in the appendix
Mothers in the control group will be given an educational brochure containing information on mother-baby nutrition and comforting the baby when crying
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