Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns

NCT05103800 | Completed DMC

• 1 other identifier: BatmanU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comfort, distress and the absence of pain can be described as free from anxiety, somewhat enjoyable and ease (peaceful) situation. The child health and disease nurse should come up with physiological problems of the baby, increase the comfort degree to reduce the stress level of the baby and ensure improvement in the baby's location. This research was experimentally designed to investigate the effect of the baby's own intrauterine heart sound on pain and comfort during the invasive procedures applied to the healthy born babies in the delivery units of the Batman Gynecology and Pediatrics Hospital. The research will be performed by selecting samples in a simple random sampling method from the babies who born healthy and timely in the normal vaginal way. The number of samples will be determined by power analysis method after pilot study. The previously white noise will have listened to the babies in experimental group and will be recorded by camera during invasive interventions and the pain and comfort scale will be applied. The scales will be applied to the control group let them without listening White noise but also will be recorded with camera and thus the data will be collected. A nurse working in the unit will perform invasive interventions, later two specialists will watch video records and so the pain and comfort scales will be filled. No study on this subject was found in the international literature review. Based on the need to fill this gap in the literature, it seems that the study will contribute to the field of child health and diseases nursing.

Conditions

Pain, Acute; Child Behavior; Newborn

Keywords

Child Health and Nursing; Pain; Newborn; Comfort

Outcome Measures

Primary Outcomes (1)

• Newborn Comfort Behavior Scale (COMFORTneo Behavior Scale)

  Newborn Comfort Behavior Scale is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. It was stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort. In addition, a score of 4-6 on the numerical evaluation scales indicates moderate pain and a score of 7-10 indicates severe pain and distress.

  6 months

Secondary Outcomes (1)

• Neonatal Infant Paint Scale

  6 months

Study Arms (2)

control group

NO INTERVENTION

Babies in the control group will not listen to any sound during the invasive procedures, the procedure will be recorded with a camera, and at the end of the study, the camera images will be watched by two experts in the field and the pain and comfort scale will be filled.

Experimental group

EXPERIMENTAL

During the invasive interventions, the white noise prepared by the researcher for the babies in the experimental group will be started to be listened to 5 minutes before the start of the intervention and will be listened to for 5 more minutes during and after the intervention. At the same time, the procedure will be recorded with a camera. At the end of the study, the camera images will be watched by two experts in the field. comfort scale will be filled.

Behavioral: invasive interventions

Interventions

invasive interventions BEHAVIORAL

listening the white noise during the invasive interventions

Also known as: white noise

Experimental group

Eligibility Criteria

• Age: 5 Minutes - 3 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Babies who were born by normal vaginal delivery
• Babies who were born in the delivery room of Batman Training and Research Hospital

You may not qualify if:

• Congenital anomalies
• Cranial hemorrhage
• Who need oxygen support
• Who have sepsis or suspected sepsis

Sponsors & Collaborators

• Batman University: lead

Study Sites (1)

Çukurova University

Adana, 1380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Child Behavior; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tuğba TODIL

  Cukurova 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: Lecturer

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: November 2, 2021
• Study Start: November 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)