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Facilitated Tucking Position, Gentle Human Touch Practices and Pain

Primary Purpose

Pain, Premature

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Facilitated Tucking Position
Gentle Human Touch
Sponsored by
Adiyaman University Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

34 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Adıyaman University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Facilitated Tucking Position

Gentle Human Touch

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pulse Oximeter Device
It was used for the measurement of oxygen saturation and heart rate before, during and after heel lancing in all three groups.

Full Information

First Posted
June 30, 2023
Last Updated
October 21, 2023
Sponsor
Adiyaman University Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05948098
Brief Title
Facilitated Tucking Position, Gentle Human Touch Practices and Pain
Official Title
The Effect of Facilitated Tucking Position and Gentle Human Touch Practices on the Perception of Pain During Heel Blood Collection in Premature Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
September 21, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Neonatal pain negatively affects prognosis, behavior, environmental adaptation, development of the brain and senses, and interaction. Effective management of neonatal pain supports health and recovery, shortens hospital stays, and reduces care costs and the prevalence of neurobehavioral problems. Therefore, proper management of pain in newborns is important for the healthy development of newborns. Many invasive procedures are applied to newborns hospitalized in neonatal intensive care units. Non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and gentle human touch have proven to have positive effects on the pain experienced by newborns during interventional procedures. In this study, the effect of facilitated tucking position and gentle human touch practices applied during heel blood collection on the perception of pain in premature newborns will be examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Premature

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facilitated Tucking Position
Arm Type
Experimental
Arm Description
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.
Arm Title
Gentle Human Touch
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated Tucking Position
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Gentle Human Touch
Intervention Description
It is a form of healing touch
Primary Outcome Measure Information:
Title
Neonatal Pain Diagnostic Scale (NIPS)
Description
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.
Time Frame
1 minutes
Secondary Outcome Measure Information:
Title
Pulse Oximeter Device
Description
It was used for the measurement of oxygen saturation and heart rate before, during and after heel lancing in all three groups.
Time Frame
1 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuba Koç Özkan
Organizational Affiliation
Adiyaman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adıyaman University
City
Adıyaman
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Facilitated Tucking Position, Gentle Human Touch Practices and Pain

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