Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455631
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
The Effect of Non-pharmacological Methods on Pain
Sponsor:
Fenerbahce University
Organization:
Fenerbahce University
Study Overview
Official Title:
The Effect of Facilitated Tucking Oral Breast Milk and Kangaroo Care on Pain During Band Removal in Preterm Newborns
Status:
NOT_YET_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:
The research will be conducted using a randomized controlled experimental methodThe preterm newborns included in the study will be randomized into three groups using the sealed envelope method In the facilitated tucking position oral breast milk group preterm newborns will be placed in the facilitated tucking position 15 minutes before tape removal and given oral breast milk 2 minutes before This position will be maintained until 2 minutes after tape removal Preterm newborns in the kangaroo care oral breast milk group will undergo kangaroo care 15 minutes before tape removal and receive oral breast milk 2 minutes before Kangaroo care allows mother-baby interaction but no feeding In the control group newborns will undergo routine nesting with gentle touch and verbal comfort provided if they cryThis study is designed to evaluate the effect of the fetal position oral breast milk administration and kangaroo care on pain during tape removal in preterm newborns
Detailed Description:
In the study the groups of the babies will be determined by a lottery method Preterm babies included in the study will be randomly assigned to three groups using a closed envelope method To ensure equal distribution of babies according to gestational age two sets of envelopes will be created for 30-336 weeks and 34-366 weeks An independent nurse working in the NICU will be asked to select a paper from the closed envelope corresponding to the babys gestational week Based on the number written on the selected paper the baby will be included in the study group The groups will be Group 1 - facilitated tucking position oral breast milk Group 2 - kangaroo care oral breast milk and Group 3 - control group After the babies are assigned to the groups data collection will begin
Before data collection the researcher will provide necessary information about the study to the families of the newborns who meet the sample selection criteria and will answer their questions After obtaining written consent from the parents of the babies who agree to participate they will be included in the study The information in the introductory information form for the newborn and parents will be recorded by the researcher
1 Breast Milk Administration Procedure During tape removal babies will be given breast milk orally The amount of milk given to the baby will be adjusted according to gestational age 15 ml for 301-32 weeks 2 ml for 321-366 weeks Peng et al 2018
2 Tape Removal Procedure The same product medical tape suitable for the baby and causing minimal tissue trauma will be used to effectively secure medical devices To remove the tape moistened gauze or saline pads will be used to gently and slowly remove it parallel to the skin surface horizontally
1 GROUP Interventions for the Facilitated Tucking Position Oral Breast Milk Group Preterm newborns in the facilitated tucking position oral breast milk group will be placed in the facilitated tucking position by the researcher 15 minutes before the tape removal procedure and given oral breast milk 2 minutes before the tape removal procedure The facilitated tucking position will be maintained until 2 minutes after the tape removal procedure To prevent heat loss preterm newborns will be positioned in the right lateral position inside the incubator by using the incubator windows without opening the incubator lid with their arms and legs brought to the midline in the facilitated tucking position
2 GROUP Interventions for the Kangaroo Care Oral Breast Milk Group Preterm newborns in the kangaroo care oral breast milk group will receive kangaroo care from the researcher 15 minutes before the tape removal procedure to alleviate pain oral breast milk will be given 2 minutes before the tape removal procedure The mothers of the babies in this group will be seated in the neonatal intensive care unit NICU and a nurse will place the newborn upright between the mothers bare breasts slightly extending the head to facilitate breathing The legs will be spread under the mothers chest and positioned in flexion The back will be wrapped with extra fabric up to the ear level to prevent heat loss During the contact the mother will be allowed to talk to move or engage in other activities with her baby but feeding will not be permitted After ensuring the comfort of both the newborn and the mother this position will be maintained for 15 minutes before the tape removal procedure Subsequently the nurse will perform the tape removal while the newborn is in the kangaroo care position and the mother and baby will remain in kangaroo care for an additional 2 minutes Once data collection is complete kangaroo care can continue based on the mothers wishes the babys condition and clinical circumstances
Interventions for the CONTROL Group Newborns in the control group will undergo the routine nesting procedure of the clinic All newborns will be placed in the lateral position For ethical reasons if babies cry during or after the procedure gentle touch and verbal comfort will be provided to them
In all experimental groups heart rate respiratory rate oxygen saturation values and PIPP-R scores will be measured and recorded at the following time points
0 minutes Measurements will be taken and recorded immediately before any intervention while the baby is in a resting position Then depending on the babys group either the facilitated tucking position or kangaroo care will be applied
13 minutes Measurements will be taken and recorded immediately before giving oral breast milk
15 minutes Measurements will be taken and recorded during the tape removal procedure
17 minutes Measurements will be taken and recorded 2 minutes after the tape removal procedure while non-pharmacological interventions continue
In the control group similar measurements and assessments will be conducted at the same time intervals and recorded
The PIPP-R scores of all groups will be recorded on a data assessment form by two independent evaluators based on video recordings
Before data collection the researcher will provide necessary information about the study to the families of the newborns who meet the sample selection criteria and will answer their questions After obtaining written consent from the parents of the babies who agree to participate they will be included in the study The information in the introductory information form for the newborn and parents will be recorded by the researcher
1 Breast Milk Administration Procedure During tape removal babies will be given breast milk orally The amount of milk given to the baby will be adjusted according to gestational age 15 ml for 301-32 weeks 2 ml for 321-366 weeks Peng et al 2018
2 Tape Removal Procedure The same product medical tape suitable for the baby and causing minimal tissue trauma will be used to effectively secure medical devices To remove the tape moistened gauze or saline pads will be used to gently and slowly remove it parallel to the skin surface horizontally
1 GROUP Interventions for the Facilitated Tucking Position Oral Breast Milk Group Preterm newborns in the facilitated tucking position oral breast milk group will be placed in the facilitated tucking position by the researcher 15 minutes before the tape removal procedure and given oral breast milk 2 minutes before the tape removal procedure The facilitated tucking position will be maintained until 2 minutes after the tape removal procedure To prevent heat loss preterm newborns will be positioned in the right lateral position inside the incubator by using the incubator windows without opening the incubator lid with their arms and legs brought to the midline in the facilitated tucking position
2 GROUP Interventions for the Kangaroo Care Oral Breast Milk Group Preterm newborns in the kangaroo care oral breast milk group will receive kangaroo care from the researcher 15 minutes before the tape removal procedure to alleviate pain oral breast milk will be given 2 minutes before the tape removal procedure The mothers of the babies in this group will be seated in the neonatal intensive care unit NICU and a nurse will place the newborn upright between the mothers bare breasts slightly extending the head to facilitate breathing The legs will be spread under the mothers chest and positioned in flexion The back will be wrapped with extra fabric up to the ear level to prevent heat loss During the contact the mother will be allowed to talk to move or engage in other activities with her baby but feeding will not be permitted After ensuring the comfort of both the newborn and the mother this position will be maintained for 15 minutes before the tape removal procedure Subsequently the nurse will perform the tape removal while the newborn is in the kangaroo care position and the mother and baby will remain in kangaroo care for an additional 2 minutes Once data collection is complete kangaroo care can continue based on the mothers wishes the babys condition and clinical circumstances
Interventions for the CONTROL Group Newborns in the control group will undergo the routine nesting procedure of the clinic All newborns will be placed in the lateral position For ethical reasons if babies cry during or after the procedure gentle touch and verbal comfort will be provided to them
In all experimental groups heart rate respiratory rate oxygen saturation values and PIPP-R scores will be measured and recorded at the following time points
0 minutes Measurements will be taken and recorded immediately before any intervention while the baby is in a resting position Then depending on the babys group either the facilitated tucking position or kangaroo care will be applied
13 minutes Measurements will be taken and recorded immediately before giving oral breast milk
15 minutes Measurements will be taken and recorded during the tape removal procedure
17 minutes Measurements will be taken and recorded 2 minutes after the tape removal procedure while non-pharmacological interventions continue
In the control group similar measurements and assessments will be conducted at the same time intervals and recorded
The PIPP-R scores of all groups will be recorded on a data assessment form by two independent evaluators based on video recordings
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