Clinical trial NCT05801640: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premature
Feeding Behavior
Infant, Premature, Diseases
Keywords: Premature
Reiki
Pain
Facilitated tucking
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 45
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Newborn Information Form
timeFrame: One measurement- Half an hour before the intervention
measure: Neonatal Stress Scale
timeFrame: First measurement- 1 minute before OG tube insertion
measure: Neonatal Stress Scale
timeFrame: Second measurement- 1 minute after OG tube insertion
measure: Physiological Parameter Tracking Chart
timeFrame: First measurement- 1 minute before OG tube insertion
measure: Physiological Parameter Tracking Chart
timeFrame: Second measurement 1 minute after OG tube insertion
measure: The premature infant pain profile-revised (PIPP-R)
timeFrame: Two measurements: First measurement- 1 minute before OG tube insertion
measure: The premature infant pain profile-revised (PIPP-R)
timeFrame: Second measurement 1 minute after OG tube insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Hatice Onal, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nigde Omer Halisdemir University
name: Halil Degirmencioglu, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.