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

Primary Purpose

Preterm, Pain, Infant ALL

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Touch Methods
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm focused on measuring touch, preterm infant, pain

Eligibility Criteria

24 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Acibadem Health Group Ataşehir HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

No Intervention and Touch Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Change in Oxygen saturation
Oxygen saturation will be evaluated using the pulse oximeter
Change in Heart rate
Heart rate will be evaluated using the monitor

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
July 18, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05784857
Brief Title
The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
Official Title
The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Pain, Infant ALL
Keywords
touch, preterm infant, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention and Touch Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Touch Methods
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
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.
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.
Title
Change in Oxygen saturation
Description
Oxygen saturation will be evaluated using the pulse oximeter
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.
Title
Change in Heart rate
Description
Heart rate will be evaluated using the monitor
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehra Kan Öntürk, Assist Prof
Phone
02165004163
Email
zehra.kan@acibadem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Assist Prof
Organizational Affiliation
Acibadem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acibadem Health Group Ataşehir Hospital
City
İstanbul
State/Province
Ataşehir
ZIP/Postal Code
34750
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Assist Prof
Phone
02165004163
Email
zehra.kan@acibadem.edu.tr
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Asist Prof
Phone
02165004163
Email
zehra.kan@acibadem.edu.tr
First Name & Middle Initial & Last Name & Degree
İlçim Ercan, RN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36137912
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 2022 Sep 20.
Results Reference
result
PubMed Identifier
32601011
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.2020.102886. Epub 2020 Jun 27.
Results Reference
result
PubMed Identifier
18353332
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.
Results Reference
result
PubMed Identifier
22792482
Citation
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.
Results Reference
result

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

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