Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

NCT05801640 | Completed

• 1 other identifier: SelcukH01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature; Feeding Behavior; Infant, Premature, Diseases

Keywords

Premature; Reiki; Pain; Facilitated tucking

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Faciliated tucking position

EXPERIMENTAL

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

Reiki

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Facilitated Tucking Position OTHER

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.

Faciliated tucking position

Reiki OTHER

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.

Reiki

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational weeks,
• From the postnatal 3rd day,
• Feeding with orogastric tube
• Apgar \>5

You may not qualify if:

• Premature infants with congenital anomaly, malformation
• Premature infants on mechanical ventilator
• Premature infants receiving sedation

Sponsors & Collaborators

• Sibel Küçükoğlu: lead

Study Sites (1)

Selcuk University

Konya, 42100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26293573 BACKGROUND

• 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.

  PMID: 18353332 RESULT

MeSH Terms

Conditions

Premature Birth; Feeding Behavior; Infant, Premature, Diseases; Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Hatice Onal, M.Sc.

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

• Halil Degirmencioglu, Medicine

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single (participant and outcomes assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: April 6, 2023
• Study Start: February 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 15, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)