Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

NCT ID: NCT05801640

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-01-15

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.

Conditions

Premature; Feeding Behavior; Infant, Premature, Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Facilitated Tucking Position

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Reiki

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sibel Küçükoğlu

OTHER

Sponsor Role: lead

Responsible Party

Sibel Küçükoğlu

Professor Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatice Onal, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Halil Degirmencioglu, Medicine

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Locations

Selcuk University

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 26293573 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18353332 (View on PubMed)

Other Identifiers

SelcukH01

Identifier Type: -

Identifier Source: org_study_id