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

July 18, 2023 updated by: Zehra Kan Onturk, Acibadem University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Ataşehir
      • İstanbul, Ataşehir, Turkey, 34750
        • Recruiting
        • Acibadem Health Group Ataşehir Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • İlçim Ercan, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No Intervention and Touch Group

Each intubated infant will be follewed up during 3 aspiration procedures. Different touching techniques will be used for preterm infants in each aspiration application.

The first aspiration procedure will be performed without intervention. During the second aspiration procedure, yakson touch will be applied.Third aspiration procedure, gentle human touch will be applied.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxygen saturation
Time Frame: 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.
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.
Change in Heart rate
Time Frame: 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.
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.
Change in Pain Score
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Zehra Kan Öntürk, Assist Prof, Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2022/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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