Clinical trial NCT05524337: White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Newborn
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: 5 minutes
measure: The newborn comfort behavior scale
timeFrame: 5 minutes
Secondary outcomes:
measure: heart rate
timeFrame: 10 minutes
measure: oxygen saturation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: RN, PhD, Assoc. Prof.
name: Gülçin Özalp Gerçeker
role: STUDY_DIRECTOR
References: