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Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

Primary Purpose

Premature, Feeding Behavior, Infant, Premature, Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Facilitated Tucking Position
Reiki
Sponsored by
Sibel Küçükoğlu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature focused on measuring Premature, Reiki, Pain, Facilitated tucking

Eligibility Criteria

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

Inclusion Criteria: 32-37 Gestational weeks, From the postnatal 3rd day, Feeding with orogastric tube Apgar >5 Exclusion Criteria: Premature infants with congenital anomaly, malformation Premature infants on mechanical ventilator Premature infants receiving sedation

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Faciliated tucking position

Reiki

Control Group

Arm Description

Experiment group will receive faciliated tucking position throughout the OG inserting. The faciliated tucking position will be applied 3 minutes before the orogastric (OG) tube is inserted. This intervention will be applied throughout the OG inserting process. The application will continue for 3 more minutes after the OG is inserted.

Experiment group will receive reiki throughout the OG inserting. This group will be take reiki 3 minutes before the orogastric (OG) tube is inserted. This intervention will be applied throughout the OG inserting process. The intervention will continue for 3 more minutes after the OG is inserted.

The routine OG insertion procedure of the clinic will be performed for the control group infants without any intervention. The group will received no further intervention.

Outcomes

Primary Outcome Measures

Newborn Information Form
The descriptive characteristics form was based on a literature review conducted by the researcher (Axelin, Salanterä & Lehtonen, 2006; Kucukoglu, Kurt & Aytekin, 2015; Yin, Yang, Lee, Li, Hua & Liaw, 2015). The form consisted of items on gestational age, postnatal age, gender, birth weight (grams), type of delivery, 1st and 5th minute Apgar score, etc.
Neonatal Stress Scale
To determine the effect of facilitated tucking position on stress score during OG procedure in preterm infants. It was developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature infants. The scale is suitable for use by nurses. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities and posture, and consists of a total of 24 items in 3-likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. This form filled by a clinical nurse and researcher 2 times before, and after the procedure.
Neonatal Stress Scale
To determine the effect of facilitated tucking position on stress score during OG procedure in preterm infants. It was developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature infants. The scale is suitable for use by nurses. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities and posture, and consists of a total of 24 items in 3-likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. This form filled by a clinical nurse and researcher 2 times before, and after the procedure.
Physiological Parameter Tracking Chart
It is a form that includes the heart rate, oxygen saturation value and respiratory rate. This form filled by a clinical nurse 2 times before and after the procedure, by a clinical nurse other than the person performing the research.
Physiological Parameter Tracking Chart
It is a form that includes the heart rate, oxygen saturation value and respiratory rate. This form filled by a clinical nurse 2 times before and after the procedure, by a clinical nurse other than the person performing the research.
The premature infant pain profile-revised (PIPP-R)
The PIPP-R scale includes 3 behavioral (fringing, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral status and gestational age) items used in the assessment of pain in newborns.This form filled by a clinical nurse and researcher 2 times before, and after the procedure. The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral parameters are scored as 0,1,2,3 for each variable, reflecting the difference between the initial state and the values during the procedure.
The premature infant pain profile-revised (PIPP-R)
The PIPP-R scale includes 3 behavioral (fringing, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral status and gestational age) items used in the assessment of pain in newborns.This form filled by a clinical nurse and researcher 2 times before, and after the procedure. The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral parameters are scored as 0,1,2,3 for each variable, reflecting the difference between the initial state and the values during the procedure.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2022
Last Updated
March 24, 2023
Sponsor
Sibel Küçükoğlu
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1. Study Identification

Unique Protocol Identification Number
NCT05801640
Brief Title
Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion
Official Title
Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion in Preterm Infants: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sibel Küçükoğlu

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
The aim of this study is to determine the effects of faciliated tucking and reiki given manually during orogastric tube insertion in preterm infants treated in the NICU on stress, pain and physiological parameter (heartbeat, blood pressure, SpO2 and respiratory rate) levels.
Detailed Description
Regardless of the severity and duration, preterm infants give physiological and behavioral responses to a painful application. While infants show behavioral responses such as crying, changes in facial expressions, acceleration or deceleration in motor movements during painful interventions, they may subjectively show changes in physiological parameters such as heart rate, respiratory rate, blood pressure, and decrease in saturation value. Because preterm infants are sensitive to many stress factors and due to reasons such as separation from the mother during the treatment process, environments with excessive light, sound and temperature changes, and the absence of a single caregiver. They do not yet have the physiological maturity to cope with painful interventions. This randomized controlled trial was planned to determine the changes in stress, pain, and physiological parameters of faciliated tucking and reiki administered during orogastric tube insertion in preterm infants 32-37 weeks of gestation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Feeding Behavior, Infant, Premature, Diseases
Keywords
Premature, Reiki, Pain, Facilitated tucking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment After explaining the study to eligible and accepting parents, informed consent signatures will be obtained. Randomization will be done after obtaining informed consent from the parent. Random assignment will be made to one control group or one intervention group (faciliated tucking position:1, reiki: 1) with sequentially numbered, sealed, opaque envelopes containing randomly generated numbers in randomization. These envelopes are for a person not involved in any other trial procedure. Will be made by Randomization will be performed using the random numbers table.
Masking
ParticipantOutcomes Assessor
Masking Description
Single (participant and outcomes assessor)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Faciliated tucking position
Arm Type
Experimental
Arm Description
Experiment group will receive faciliated tucking position throughout the OG inserting. The faciliated tucking position will be applied 3 minutes before the orogastric (OG) tube is inserted. This intervention will be applied throughout the OG inserting process. The application will continue for 3 more minutes after the OG is inserted.
Arm Title
Reiki
Arm Type
Experimental
Arm Description
Experiment group will receive reiki throughout the OG inserting. This group will be take reiki 3 minutes before the orogastric (OG) tube is inserted. This intervention will be applied throughout the OG inserting process. The intervention will continue for 3 more minutes after the OG is inserted.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The routine OG insertion procedure of the clinic will be performed for the control group infants without any intervention. The group will received no further intervention.
Intervention Type
Other
Intervention Name(s)
Facilitated Tucking Position
Intervention Description
The fetal position was given by the researcher. In the fetal position, the lower and upper extremities of the baby were kept in the flexed position by hand and placed in the side-lying position close to the midline.
Intervention Type
Other
Intervention Name(s)
Reiki
Intervention Description
Reiki was applied to areas called chakras (forehead, throat, heart, stomach, feet and hands). A total of 15 minutes were applied in the form of 12 minutes touches in each chakra region.
Primary Outcome Measure Information:
Title
Newborn Information Form
Description
The descriptive characteristics form was based on a literature review conducted by the researcher (Axelin, Salanterä & Lehtonen, 2006; Kucukoglu, Kurt & Aytekin, 2015; Yin, Yang, Lee, Li, Hua & Liaw, 2015). The form consisted of items on gestational age, postnatal age, gender, birth weight (grams), type of delivery, 1st and 5th minute Apgar score, etc.
Time Frame
One measurement- Half an hour before the intervention
Title
Neonatal Stress Scale
Description
To determine the effect of facilitated tucking position on stress score during OG procedure in preterm infants. It was developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature infants. The scale is suitable for use by nurses. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities and posture, and consists of a total of 24 items in 3-likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. This form filled by a clinical nurse and researcher 2 times before, and after the procedure.
Time Frame
First measurement- 1 minute before OG tube insertion
Title
Neonatal Stress Scale
Description
To determine the effect of facilitated tucking position on stress score during OG procedure in preterm infants. It was developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature infants. The scale is suitable for use by nurses. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities and posture, and consists of a total of 24 items in 3-likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. This form filled by a clinical nurse and researcher 2 times before, and after the procedure.
Time Frame
Second measurement- 1 minute after OG tube insertion
Title
Physiological Parameter Tracking Chart
Description
It is a form that includes the heart rate, oxygen saturation value and respiratory rate. This form filled by a clinical nurse 2 times before and after the procedure, by a clinical nurse other than the person performing the research.
Time Frame
First measurement- 1 minute before OG tube insertion
Title
Physiological Parameter Tracking Chart
Description
It is a form that includes the heart rate, oxygen saturation value and respiratory rate. This form filled by a clinical nurse 2 times before and after the procedure, by a clinical nurse other than the person performing the research.
Time Frame
Second measurement 1 minute after OG tube insertion
Title
The premature infant pain profile-revised (PIPP-R)
Description
The PIPP-R scale includes 3 behavioral (fringing, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral status and gestational age) items used in the assessment of pain in newborns.This form filled by a clinical nurse and researcher 2 times before, and after the procedure. The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral parameters are scored as 0,1,2,3 for each variable, reflecting the difference between the initial state and the values during the procedure.
Time Frame
Two measurements: First measurement- 1 minute before OG tube insertion
Title
The premature infant pain profile-revised (PIPP-R)
Description
The PIPP-R scale includes 3 behavioral (fringing, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral status and gestational age) items used in the assessment of pain in newborns.This form filled by a clinical nurse and researcher 2 times before, and after the procedure. The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral parameters are scored as 0,1,2,3 for each variable, reflecting the difference between the initial state and the values during the procedure.
Time Frame
Second measurement 1 minute after OG tube insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 32-37 Gestational weeks, From the postnatal 3rd day, Feeding with orogastric tube Apgar >5 Exclusion Criteria: Premature infants with congenital anomaly, malformation Premature infants on mechanical ventilator Premature infants receiving sedation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Onal, M.Sc.
Organizational Affiliation
Nigde Omer Halisdemir University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halil Degirmencioglu, Medicine
Organizational Affiliation
Nigde Omer Halisdemir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
26293573
Citation
Kucukoglu S, Kurt S, Aytekin A. The effect of the facilitated tucking position in reducing vaccination-induced pain in newborns. Ital J Pediatr. 2015 Aug 21;41:61. doi: 10.1186/s13052-015-0168-9.
Results Reference
background
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

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Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

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