Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion in Preterm Infants: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases; Feeding Behavior; Premature
• Intervention / Treatment: Other: Facilitated Tucking Position; Other: Reiki

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42100
    • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Faciliated tucking position; 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.	Other: Facilitated Tucking Position; 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.
Experimental: Reiki; 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.	Other: Reiki; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One measurement- Half an hour before the intervention
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.	First measurement- 1 minute before OG tube insertion
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.	Second measurement- 1 minute after OG tube insertion
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.	First measurement- 1 minute before OG tube insertion
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.	Second measurement 1 minute after OG tube insertion
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.	Two measurements: First measurement- 1 minute before OG tube insertion
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.	Second measurement 1 minute after OG tube insertion

Collaborators and Investigators

• Sponsor: Sibel Küçükoğlu
• Investigators: Principal Investigator: Hatice Onal, M.Sc., Nigde Omer Halisdemir University; Principal Investigator: Halil Degirmencioglu, Medicine, Nigde Omer Halisdemir University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Reiki; Premature; Facilitated tucking
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Premature Birth
• Other Study ID Numbers: SelcukH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be shared after the article is published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No