Skip to content

The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration

The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05784857
Enrollment
81
Registered
2023-03-27
Start date
2023-02-24
Completion date
2025-07-01
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant ALL, Pain, Preterm

Keywords

touch, preterm infant, pain

Brief summary

Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Correct stimulation of the infant's sense of touch affects psychosocial development positively. In addition, it is reported that touch has a calming and analgesic effect during invasive interventions. Therefore, there is a need for touch appropriate for development of newborn. The aim of this study was determine the effect of Yakson and Gentle Human Touch on pain and physiologic parameters in preterm infants during endotracheal aspiration.

Detailed description

It was designed as a prospective, quasi-experimental.In this study, each intubated infant will be followed up during 3 aspiration procedures. The first aspiration procedure will be performed without intervention. During the second and third aspiration procedure, yakson and gentle touch will be applied, respectively.Physiological parameters and pain score of newborn will be evaluated before, during and immediately after aspiration. Yakson touch: Yakson touch is defined in traditional Korean culture as a kind of therapeutic touch that a mother believes will treat her sick child by stroking it with a compassionate, sincere and loving attitude. The Yakson protocol was developed by Im and Kim (2009) in an understandable form that can be easily implemented. While newborn is in supine position, practitioner applies Yakson touch. The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure. 1. Steady touch (5 minutes): One hand rest on the chest and abdomen of the preterm infant, while the other hand support the back and hip of the preterm infant. 2. Compassionate Caress (5 minutes): In the same hand position, the practitioner repeat caressing and resting for 5 minutes: Caress (1 minutes), rest (30 seconds), caress (1 minutes), rest (30 seconds), and caress (2 minutes). The practitioner caress the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 second. 3. Steady touch (5 minutes): The practitioner follow the steady touch procedure as previously describe. Gentle Human Touch: Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.

Interventions

OTHERTouch Methods

The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure. Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 37 Weeks
Healthy volunteers
Yes

Inclusion criteria

* The gestational week of the infant is less than 38 * Absence of congenital anomaly * Mechanical ventilator support * Absence of comorbid disease * Not having undergone surgery * No analgesic medication has been administered in the last hour

Exclusion criteria

• Infants with diseases such as sepsis that interfere with the application of touch technique

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain ScoreData will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed for preterm and term babies. The Turkish validity and reliability study was conducted in 2017. Crying, irritability, behavior-state, facial expression, extremity tone, and vital signs parameters are evaluated in the N-PASS scale. In this scale is evaluated with triple likert type and pain score can be between 0 and 10. Permission was obtained from the authors to use the scale.
Change in Oxygen saturationData will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.Oxygen saturation will be evaluated using the pulse oximeter
Change in Heart rateData will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.Heart rate will be evaluated using the monitor

Countries

Turkey (Türkiye)

Contacts

Primary ContactZehra Kan Öntürk, Assist Prof
zehra.kan@acibadem.edu.tr02165004163

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026