PainNCT06455631
The Effect of Non-pharmacological Methods on Pain
A study testing Facilitated Tucking, Oral Breast Milk , Kangaroo Care in people with Pain and Infant ALL, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted using a randomized controlled experimental method.The preterm newborns included in the study will be randomized into three groups using the sealed envelope method. Read more about this study
- Who is it for?
- Ages 30 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain, Infant ALL, Preterm
- What is being tested?
- Facilitated Tucking, Oral Breast Milk , Kangaroo Care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 30 and 36+6 weeks
- The newborn not having undergone a painful procedure at least 1 hour before the intervention
- Not having received analgesic and/or sedative medication in the last hour
- Presence of maternal breast milk
- Not having received oral or enteral feeding in the last hour
- Not receiving continuous positive airway pressure (CPAP) or oxygen therapy
Who cannot join
- Having ventilator support
- Having a congenital anomaly
- Undergoing continuous sedative treatment
- Having a congenital malformation that could cause asphyxia and affect breathing
- Having intracranial hemorrhage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fenerbahce University
Ataşehir, Istanbul, 34758
About this study
Official title: The Effect of Facilitated Tucking, Oral Breast Milk, and Kangaroo Care on Pain During Band Removal in Preterm Newborns
The research will be conducted using a randomized controlled experimental method.The 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 cry.This 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.
Read the 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 30-33+6 weeks and 34-36+6 weeks. An independent nurse working in the NICU will be asked to select a paper from the closed envelope corresponding to the baby's 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.
- 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 (1.5 ml for 30+1-32 weeks; 2 ml for 32+1-36+6 weeks) (Peng et al., 2018).
- 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.
- 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.
- 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 mother's bare breasts, slightly extending the head to facilitate breathing. The legs will be spread under the mother's 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 mother's wishes, the baby's 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 baby's 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.
- Conditions
- Pain, Infant ALL, Preterm
- Being tested
- Facilitated Tucking, Oral Breast Milk , Kangaroo Care
- Keywords
- Preterm Infant, Oral Breast Milk, Fetal Position, Kangaroo Care, Band Removal, Pain
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Tucking, Oral Breast Milk , Kangaroo CareProcedure or surgery
Before data collection, the researcher will inform families of newborns meeting the sample criteria about the study and obtain written consent from participating parents. Newborn and parent information will be recorded. Procedures will occur between 08:00 and 16:00, with one researcher, two nurses, and a preterm newborn present during tape removal. Tape removal will be done by the same nurse. Physiological and behavioral responses will be recorded before, during, and after tape removal. Breast milk will be orally administered during tape removal, with the amount adjusted based on gestational age. Measurements will be taken at specified time points, including heart rate, respiratory rate, oxygen saturation, and PIPP-R score. These procedures will also apply to the control group. PIPP-R scores will be recorded by two evaluators based on video recordings.
| Study group | Role | What they receive |
|---|---|---|
| Oral Breast Milk and Facilitated Tucking | Experimental | In the facilitated tucking position + oral breast milk group, preterm newborns 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, the preterm newborns will be placed in the fetal position inside the incubator by using the incubator windows without opening the incubator lid. Receives: Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo Care |
| Kangaroo Care and Oral Breast Milk Odor | Experimental | In the kangaroo care + oral breast milk group, preterm newborns will undergo kangaroo care 15 minutes prior to tape removal and receive oral breast milk 2 minutes before. During kangaroo care, mothers can interact with their babies but cannot feed them. After ensuring comfort, this position will be maintained for 15 minutes before tape removal. The nurse will then remove the tape while the baby is in kangaroo care, followed by an additional 2 minutes of kangaroo care. Kangaroo care can continue post-data collection based on maternal preference, baby's condition, and clinical circumstances. Receives: Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo Care |
| Control | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in preterm infant
We will assess newborns' pain using the PIPP-R tool before the procedure and at 13, 15, and 17 minutes after starting the procedure.
Measured: Maximum 17 minutes
Secondary outcomes (3)
Heart rate
In order to determine the infant's heart rate, a 'Covidien' pulse oximeter will be used. It will be recorded by the observing nurse in the observation form before the procedure and at 13, 15, and 17 minutes after starting the procedure.
Measured: Maximum 17 minutes
Oxygen Saturation
In order to determine the infant's oxygen saturation, a 'Covidien' pulse oximeter will be used. It will be recorded by the observing nurse in the observation form before the procedure and at 13, 15, and 17 minutes after starting the procedure.
Measured: Maximum 17 minutes
Respiratory rate
A Casio brand stopwatch will be used to count the respiratory rate of the preterm newborn.
Measured: Maximum 17 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start10 Aug 2024
- Primary completion10 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Negarin Akbari, Fenerbahce University
- Investigators
- Cana Genç, Ph.D student, Principal investigator, Fenerbahce UniversityDuygu Gözen, Ph.D, Study chair, Koç Universityİrem Baylı, Ms.C, Principal investigator, Medipol hospitalAyhan Taştekin, Dr, Principal investigator, Medipol hospitalNegarin Akbari, Study chair, Department of Nursing, Faculty of Health Sciences, Fenerbahce University, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455631
- Sponsor's protocol ID
- E-10840098-202.3.02-3029
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facilitated Tucking, Oral Breast Milk, and Kangaroo Care on Pain During Band Removal in Preterm Newborns
- ClinicalTrials.gov ID
- NCT06455631
- Acronym / sponsor ID
- E-10840098-202.3.02-3029
- Conditions
- Pain, Infant ALL, Preterm
- Keywords
- Preterm Infant, Oral Breast Milk, Fetal Position, Kangaroo Care, Band Removal, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research will be conducted using a randomized controlled experimental method.The 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 cry.This 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 30-33+6 weeks and 34-36+6 weeks. An independent nurse working in the NICU will be asked to select a paper from the closed envelope corresponding to the baby's 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.
- 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 (1.5 ml for 30+1-32 weeks; 2 ml for 32+1-36+6 weeks) (Peng et al., 2018).
- 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.
- 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.
- 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 mother's bare breasts, slightly extending the head to facilitate breathing. The legs will be spread under the mother's 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 mother's wishes, the baby's 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 baby's 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Breast Milk and Facilitated Tucking | Experimental | Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo CareIn the facilitated tucking position + oral breast milk group, preterm newborns 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, the preterm newborns will be placed in the fetal position inside the incubator by using the incubator windows without opening the incubator lid. |
| Kangaroo Care and Oral Breast Milk Odor | Experimental | Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo CareIn the kangaroo care + oral breast milk group, preterm newborns will undergo kangaroo care 15 minutes prior to tape removal and receive oral breast milk 2 minutes before. During kangaroo care, mothers can interact with their babies but cannot feed them. After ensuring comfort, this position will be maintained for 15 minutes before tape removal. The nurse will then remove the tape while the baby is in kangaroo care, followed by an additional 2 minutes of kangaroo care. Kangaroo care can continue post-data collection based on maternal preference, baby's condition, and clinical circumstances. |
| Control | No intervention | –The 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. |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational age between 30 and 36+6 weeks
- The newborn not having undergone a painful procedure at least 1 hour before the intervention
- Not having received analgesic and/or sedative medication in the last hour
- Presence of maternal breast milk
- Not having received oral or enteral feeding in the last hour
Key exclusion criteria (5 listed)
- Having ventilator support
- Having a congenital anomaly
- Undergoing continuous sedative treatment
- Having a congenital malformation that could cause asphyxia and affect breathing
- Having intracranial hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated Tucking, Oral Breast Milk , Kangaroo CareBefore data collection, the researcher will inform families of newborns meeting the sample criteria about the study and obtain written consent from participating parents. Newborn and parent information will be recorded. Procedures will occur between 08:00 and 16:00, with one researcher, two nurses, and a preterm newborn present during tape removal. Tape removal will be done by the same nurse. Physiological and behavioral responses will be recorded before, during, and after tape removal. Breast milk will be orally administered during tape removal, with the amount adjusted based on gestational age. Measurements will be taken at specified time points, including heart rate, respiratory rate, oxygen saturation, and PIPP-R score. These procedures will also apply to the control group. PIPP-R scores will be recorded by two evaluators based on video recordings. | Procedure or surgery | Kangaroo Care and Oral Breast Milk Odor, Oral Breast Milk and Facilitated Tucking |
Primary outcome
Pain in preterm infant
Time frame: Maximum 17 minutes
We will assess newborns' pain using the PIPP-R tool before the procedure and at 13, 15, and 17 minutes after starting the procedure.
3 secondary outcomes
Heart rate
Time frame: Maximum 17 minutes
Oxygen Saturation
Time frame: Maximum 17 minutes
Respiratory rate
Time frame: Maximum 17 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cana Genç, Ph.D student principal investigator
Fenerbahce University
Duygu Gözen, Ph.D study chair
Koç University
İrem Baylı, Ms.C principal investigator
Medipol hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Tucking, Oral Breast Milk , Kangaroo Care in people with Pain and Infant ALL, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in preterm infant (time frame: Maximum 17 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.