Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

Feeding Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05801640
• Other study ID #: SelcukH01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: March 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 15, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior
• Infant, Premature, Diseases
• Premature
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Sibel Küçükoglu

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 Bolisik (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
Primary	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 Bolisik (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
Primary	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
Primary	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
Primary	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
Primary	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