Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration

NCT ID: NCT06308991

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-06-01

Brief Summary

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The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

Detailed Description

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Background: Preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain.

Aims: To determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

Design: A randomized controlled crossover trial. Setting: This study was conducted in the neonatal intensive care unit between July 2022 and June 2023.

Methods: Thirty neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale and COMFORT neo were used to collect the data.

Conditions

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Endotracheal Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant.

Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Yakson touch

The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In the Yakson touch method, the palms of the practitioner and all fingers were kept in close contact so that the infants did not feel pressure.

1. Steady touch (5 minutes): One hand rested on the chest and abdomen of the preterm infant, while the other hand supported the back and hip of the preterm infant.
2. Compassionate Caress (5 minutes): In the same hand position, the practitioner repeated caressing and resting for 5 minutes: Caress (1 minute), rest (30 seconds), caress (1 minute), rest (30 seconds), and caress (2 minutes). The practitioner caressed the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 seconds.
3. Steady touch (5 minutes): The practitioner followed the steady touch procedure as previously described.

Group Type EXPERIMENTAL

Yakson touch

Intervention Type OTHER

Yakson touch method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes).

Gentle Human Touch

While the practitioner placed one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was placed on the lower abdomen covering the waist and hip of the infant.

Group Type EXPERIMENTAL

Gentle Human Touch

Intervention Type OTHER

Gentle Human Touch (GHT) method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The GHT method continued for 15 minutes.

Routine Care

All infants in the control, Yakson, and GHT groups were applied swaddling as the routine practice of the clinic before and during painful procedures.

Group Type OTHER

Routine care

Intervention Type OTHER

Infants in the Routine care will be applied swaddling. It will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.

Interventions

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Yakson touch

Yakson touch method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes).

Intervention Type OTHER

Gentle Human Touch

Gentle Human Touch (GHT) method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The GHT method continued for 15 minutes.

Intervention Type OTHER

Routine care

Infants in the Routine care will be applied swaddling. It will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
* Infants undergoing ventilator support with an endotracheal tube

Exclusion Criteria

* Infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before
* Infants congenital anomalies, sepsis or haemorrhagic disease that might prevent Yakson and GHT
* Infants who underwent surgery and had a chest tube
* Infants with intracranial hemorrhage
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Democracy University

OTHER

Sponsor Role lead

Responsible Party

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Sadiye Dur

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sadiye Dur, PhD

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Seda Caglar, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Izmir Democracy University

Karabağlar, İzmir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IDU-SBF-SD-01

Identifier Type: -

Identifier Source: org_study_id

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