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CompletedNCT06455631Updated Feb 18, 2025

The Effect of Non-pharmacological Methods on Pain

An interventional study of Facilitated Tucking, Oral Breast Milk , Kangaroo Care in Pain, Infant ALL and Preterm, sponsored by Fenerbahce University. Completed at 1 site in Turkey. Open to participants aged 30 Weeks to 36 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-18.

Sponsored by Fenerbahce University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
30 Weeks to 36 Weeks
Sex
All
01

Study 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. 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.

  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 (1.5 ml for 30+1-32 weeks; 2 ml for 32+1-36+6 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.
  1. 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.

02

Conditions studied

  • Pain
  • Infant ALL
  • Preterm

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Keywords

  • Preterm Infant
  • Oral Breast Milk
  • Fetal Position
  • Kangaroo Care
  • Band Removal
  • Pain
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 120 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Fenerbahce University is the lead sponsor of 73 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Gestational age between 30 and 36+6 weeks
  2. The newborn not having undergone a painful procedure at least 1 hour before the intervention
  3. Not having received analgesic and/or sedative medication in the last hour
  4. Presence of maternal breast milk
  5. Not having received oral or enteral feeding in the last hour
  6. Not receiving continuous positive airway pressure (CPAP) or oxygen therapy

Exclusion criteria

Exclusion Criteria:

  1. Having ventilator support
  2. Having a congenital anomaly
  3. Undergoing continuous sedative treatment
  4. Having a congenital malformation that could cause asphyxia and affect breathing
  5. Having intracranial hemorrhage
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Oral Breast Milk and Facilitated Tucking

    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.

    Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo Care

  • Experimental
    Kangaroo Care and Oral Breast Milk Odor

    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.

    Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo Care

  • No intervention
    Control

    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.

Interventions

  • ProcedureFacilitated Tucking, Oral Breast Milk , Kangaroo Care

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Maximum 17 minutes

Secondary outcomes

  1. 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.

    Time frame: Maximum 17 minutes

  2. 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.

    Time frame: Maximum 17 minutes

  3. Respiratory rate

    A Casio brand stopwatch will be used to count the respiratory rate of the preterm newborn.

    Time frame: Maximum 17 minutes

07

Study locations

1 site
  • Fenerbahce University
    Atasehir, Istanbul 34758, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06455631
Lead sponsor
Fenerbahce University
Responsible party
Negarin Akbari (Assisstant Professor, Fenerbahce University) — Principal investigator
First posted
Jun 12, 2024
Start date
Aug 10, 2024
Primary completion
Feb 10, 2025
Completion
Feb 14, 2025
Last update
Feb 18, 2025

Study contacts

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
Ayhan Taştekin, Dr
principal investigator · Medipol hospital
Negarin Akbari
study chair · Department of Nursing, Faculty of Health Sciences, Fenerbahce University, Istanbul, Turkey

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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