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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784857
• Other study ID #: ATADEK-2022/17
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2023
• Source: Acibadem University
• Contact: Zehra Kan Öntürk, Assist Prof
• Phone: 02165004163
• Email: zehra.kan[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant ALL
• Pain
• Premature Birth
• Preterm

Intervention

Other:
• Touch 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.

Locations

Country	Name	City	State
Turkey	Acibadem Health Group Atasehir Hospital	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bahman Bijari B, Iranmanesh S, Eshghi F, Baneshi MR. Gentle Human Touch and Yakson: The Effect on Preterm's Behavioral Reactions. ISRN Nurs. 2012;2012:750363. doi: 10.5402/2012/750363. Epub 2012 Jun 25. — View Citation

Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102 — View Citation

Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18. — View Citation

Nist MD, Robinson A, Harrison TM, Pickler RH. An integrative review of clinician-administered comforting touch interventions and acute stress responses of preterm infants. J Pediatr Nurs. 2022 Nov-Dec;67:e113-e122. doi: 10.1016/j.pedn.2022.08.020. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Score	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.	Data 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.
Primary	Change in Oxygen saturation	Oxygen saturation will be evaluated using the pulse oximeter	Data 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.
Primary	Change in Heart rate	Heart rate will be evaluated using the monitor	Data 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.