NCT05524337

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Acute
• Newborn

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-22
• Completion: 2023-07-22
• First posted: 2022-09-01
• Last updated: 2025-03-17

Locations

1 site across 1 country: Turkey (Türkiye)