Facilitated Tucking Position, Gentle Human Touch Practices and Pain

NCT05948098 | Completed

• 1 other identifier: HRÜ/230818
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study is planned as a randomized controlled study to evaluate the effect of facilitated tucking position and gentle human touch practices on the pain experienced by newborns during heel blood collection. This study is planned to be carried out between 15 July and 15 December 2023 in the neonatal intensive care unit of a training and research hospital in the Southeastern Anatolia Region. The sample size was calculated based on the study of premature infants to determine the effect of facilitated tucking position on procedural pain. According to the results of the study, PIPP pain scores were determined as 11.88±3.05 in the intervention group (n=17) and 9.06±2.95 in the control group (n=17). The effect size of the study was determined as d= 0.939 at α=0.05 level and 95% confidence interval. It was decided to conduct the study with a total of 90 premature babies, 30 of whom were in the groups, in case of data loss during the study.

Conditions

Pain; Premature

Outcome Measures

Primary Outcomes (1)

• Neonatal Pain Diagnostic Scale (NIPS)

  It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.

  1 minutes

Secondary Outcomes (1)

• Pulse Oximeter Device

  1 minutes

Study Arms (3)

Facilitated Tucking Position

EXPERIMENTAL

Prior to the procedure, parents will be informed about facilitated tucking position practices.Heel blood will be drawn from newborns after facilitated tucking position practices are performed. The pain of newborns will be evaluated with the "Neonatal Pain Diagnostic Scale (NIPS)" before, during and after the procedure. Practice: For the facilitated tucking position, the lower and upper extremities of the newborn will be kept in lateral flexion and close to the midline. Meanwhile, the researcher's hand will be gently held on the baby's head and the other hand on the baby's hips, without restricting the baby's movements. The facilitated tucking position will be given one minute before the heel blood collection and will be maintained for one minute during and after the blood collection.

Behavioral: Facilitated Tucking Position

Gentle Human Touch

EXPERIMENTAL

Before the procedure, parents will be informed about gentle human touch practice. After Gentle human touch practice, heel blood will be taken from newborns. The pain of newborns will be evaluated with the "Neonatal Pain Diagnostic Scale (NIPS)" before, during and after the procedure. Practice: For the Gentle human touch practice, the researcher will place one hand on the newborn's top (head) above the brow line and the other hand on the lower abdomen covering the baby's waist and hips. Gentle human touch practice will be started 10-15 minutes before the procedure and will continue throughout the process and until 15 minutes after the end of the process.

Behavioral: Gentle Human Touch

Control Group

NO INTERVENTION

During the heel blood collection, no procedures other than routine procedures applied in the clinic will be applied. The pain of newborns will be evaluated with the "Neonatal Pain Diagnostic Scale (NIPS)" before, during and after the procedure.

Interventions

Facilitated Tucking Position BEHAVIORAL

a sub-form of method of nesting the baby and the procedure of bringing the body to middle or even close position by holding the upper and lower extremities of the baby in flexion with hands

Facilitated Tucking Position

Gentle Human Touch BEHAVIORAL

It is a form of healing touch

Gentle Human Touch

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature newborns (34-37 weeks of gestation), dependent on nasal CPAP, without congenital anomalies, not taking sedative or analgesic drugs, not receiving oral feeding, and whose parents approved to participate in the study will be included in the study.

You may not qualify if:

• Newborns with open wounds on their body, bleeding disorders, and those who underwent a painful procedure just before heel blood sampling will not be included in the study.

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adıyaman University

Adıyaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Premature Birth

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tuba Koç Özkan

  Adiyaman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 17, 2023
• Study Start: July 20, 2023
• Primary Completion: September 21, 2023
• Study Completion: October 15, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)