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

NCT05103800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-07-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

invasive interventions

listening the white noise during the invasive interventions

Sponsors & Collaborators

  • Batman University

    lead OTHER

Principal Investigators

  • Tuğba TODIL · Cukurova University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Minutes
Max Age
3 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-03-15
Completion
2022-05-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103800 on ClinicalTrials.gov