White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance

Pain, Acute Clinical Trial

— noisetouch  

Official title:

The Effect of White Noise and Therapeutic Touch on Physiological Parameters, Pain and Comfort Level in Newborns During Heel Blood Collection: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524337
• Other study ID #: 6943 GOA
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 22, 2023

Study information

• Verified date: August 2022
• Source: Dokuz Eylul University
• Contact: Gülçin Özalp Gerçeker, pHD
• Phone: 05306411368
• Email: gulcinozalp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled study was planned to evaluate the effects of listening to white noise and therapeutic touch on physiological parameters, pain and comfort level during the heel blood collection procedure on infants who gave birth at 32 weeks and above and were given to their mothers in Atatürk Training and Research Hospital.

Description:

Hypotheses H1: Newborns who listen to white noise during heel blood collection feel less pain and have a higher comfort level. H2: Newborns who are treated with therapeutic touch during heel blood collection feel less pain and have a higher comfort level. H3: Newborns who listen to white noise and apply therapeutic touch during heel blood collection feel less pain and have a higher comfort level. H4: There is a difference between the pain and comfort levels of newborns in terms of group, group-time and time according to the intervention applied. Methods Mothers of newborns whose heel blood will be taken will be informed about the research. The mothers will be informed about the fact that heel blood collection is a routine practice, the data will be recorded by the nurse and 2 observers who take heel blood in the study, and they will also be informed about the white noise and therapeutic touch practices to be listened to, and their written consent will be obtained. After obtaining informed written consent, it will be determined which group the newborn belongs to by stratified randomization. Stratified randomization was applied according to gender and week of birth. A standard approach will be applied to all newborns. Standard approach; If the baby is asleep, the heel blood will be taken, he will be woken up, put on a denim bed, his upper extremities will be gently wrapped with a blanket, and the procedure will be performed by the nurse. Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection; Observational findings including heart rates, SpO2 values, pain and confort scores will be recorded in the data form. No additional care will be given to ensure physiological stability in all groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 22, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

Inclusion Criteria:

• Babies who are 32 weeks and older given to their mothers who were born healthy

Exclusion Criteria:

• Newborns 32 weeks and over
• Delivery of the newborn to the mother after birth
• no congenital anomalies or genetic disorders
• The newborn has passed the audiology test
• Obtaining consent form from parent

Related Conditions & MeSH terms

• Acute Pain
• Newborn
• Pain, Acute

Intervention

Behavioral:
• white noise
Dr. Harvery Karp's song "The Happiest Baby", consisting of intrauterine sounds only, will be used for white noise. The sound will be set to 45 db.
• therapeutic touch
In the group where therapeutic touch will be applied, the heel blood collection procedure and the study will be explained to the family, and after the consent is obtained, the therapeutic touch will be applied to the baby 5 minutes before, during and after the procedure.
• white noise and therapeutic touch
the group where therapeutic touch and white noise will be applied together, after the family is informed about the procedure, white noise will be listened to 5 minutes before, during and 5 minutes after the heel blood collection, and therapeutic touch steps will be applied during this time.

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Infant Pain Scale (NIPS)	The Newborn Infant Pain Scale (NIPS) was developed by Lawrence et al. in 1993. Turkish validity and reliability were established by Akdovan in 1999 (Akdovan, 1999). Newborn infant pain scale, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0 It is a likert-type scale consisting of 6 parameters: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless). . The assessment of pain is based on the total score.	5 minutes
Primary	The newborn comfort behavior scale	The newborn comfort behavior scale is a Likert type scale developed to evaluate the comfort needs, pain and distress of newborn babies. This scale was developed by Ambuel et al. (1992) to evaluate comfort, pain and stress in newborn babies receiving mechanical ventilator support in the intensive care unit (Ambuel et al., 1992). As a result of the application of this scale, a total score of 6-30 is reached. If the total score obtained as a result of the evaluation is between 9-13, it is emphasized that the baby is comfortable, if it is 14 and above, the baby's comfort level is low and additional interventions may be required to increase comfort.	5 minutes
Secondary	heart rate	Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection. Heart rate will recorded.	10 minutes
Secondary	oxygen saturation	Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection. Oxygen saturation will recorded.	10 minutes