Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05103800 |
| Other study ID # |
BatmanU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2021 |
| Est. completion date |
May 15, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Batman University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Comfort can be defined as the absence of distress and pain, free from anxiety, somewhat
pleasurable and relaxed (peaceful) situation. Providing comfort and calmness of the child,
relieving pain and distress are applications in the physical field of comfort theory. Nursing
interventions applied in newborns are an integral component of professional nursing care to
increase patient comfort level. The child health and diseases nurse should provide solutions
to the baby's physiological problems, increase the comfort level to reduce the baby's stress
level, and improve the baby's environment.
Many invasive attempts are applied to the newborn baby after birth without being discharged
from the hospital. These applications, which cause tissue destruction, are painful for
babies. This study was designed as experimentally in order to examine the effect of listening
white noise on pain and comfort during the invasive procedure applied to healthy babies in
the delivery room of Batman Training and Research Hospital. The hypotheses for this research
were determined as follows:
H10: Listening to white noise in newborn babies during an invasive intervention does not
affect the baby's pain.
H11: Listening to white noise in newborn babies during an invasive intervention reduces the
baby's pain.
H20: Listening to white noise in newborn babies during an invasive intervention does not
affect the comfort of the baby.
H21: Listening to white noise in newborn babies during an invasive intervention increases the
comfort of newborn babies.
In the literature review, studies were found in which attempts were made to alleviate the
interventional pain of the newborn using one or more of the sensory stimuli such as visual,
auditory, tactile, taste and smell. In the treatment of pain in the newborn; various
alternative and complementary treatments are used such as positioning, swaddling, rocking,
holding, kangaroo care applied by mother/father, massage, acupressure, reiki application,
pacifier, sweet solutions (sucrose, glucose), breastfeeding, listening to the mother's voice,
singing, lullaby, aromatherapy and, smelling familiar scents. In the literature review, the
application of white noise listening to the baby during an invasive procedure or otherwise is
limited.
In this thesis, it is aimed to increase the quality of care provided, to listen to white
noise during the invasive interventions applied to the baby, to observe the effect on the
baby's pain and comfort, to reduce the pain and to increase the comfort of the baby, and to
be a source for similar studies.
RESOURCE SUMMARY The International Organization for Pain Studies (ISAP) has defined the most
valid concept of pain today, which is a universal experience and has been tried to be
explained by human beings for centuries. According to this organization, pain, is always
subjective as it is an unpleasant nature that accompanies or can be defined by existing or
potential tissue damage. Although the most reliable indicator in pain assessment is the
patient's own expression, different pain diagnosis methods are used when evaluating pediatric
patients who have difficulty in expressing their pain. Providing comfort and calmness of the
child, relieving pain and distress are applications in the physical field of comfort theory.
Providing this aspect of comfort is possible with pain assessment and interventions for it.
Comfort, which is a word of French origin and is defined as the comfort that makes daily life
easier in the dictionary meaning, in nursing; it consists of the process of diagnosing the
comfort needs of the patient, family or society, taking precautions for their needs,
evaluating the basic comfort level and the comfort level after the application. According to
Kolcaba, comfort is "an expected result with a complex structure in physical,
psycho-spiritual, social and environmental integrity related to helping the individual's
needs, providing peace and overcoming problems". Kolcaba, as a result of her analytical
studies on the use of the concept of comfort in the nursing discipline; stated that it is a
positive, holistic, multidimensional, theoretically definable and practical concept. The
concept of comfort according to the holistic view; it is the satisfaction of basic human
needs in order to find relief, find peace and overcome problems.
After nurses started to give care systematically, they started to use various concepts;
concepts such as comfort (relaxation), care, and communication formed the basis of theory
development studies. Comfort, which is a concept traditionally associated with the art of
nursing, is an individual and holistic concept. It has been reported in the literature that
the nurses provide strength, care, support, encouragement and assistance through comfort and
comfort measures.
The concept of comfort has been used frequently in neonatal intensive care units and newborn
babies in recent years. In studies, it is stated that one of the most important factors
affecting the recovery rate is comfort. Kolcaba et al. emphasized that comfort has the effect
of increasing the benefit and cost ratios, and the level of patient satisfaction. Increasing
the patient comfort level by applying nursing interventions in newborns is an integral
component of professional nursing care. The child health and diseases nurse should provide
solutions to the baby's physiological problems, increase the comfort level to reduce the
baby's stress level, and improve the baby's environment.
In the literature review, studies were found in which attempts were made to alleviate the
interventional pain of the newborn using one or more of the sensory stimuli such as visual,
auditory, tactile, taste and smell. In the treatment of pain in the newborn various
alternative and complementary treatments are used, such as; positioning, swaddling, rocking,
holding, kangaroo care made by mother/father, massage, acupressure, reiki application,
pacifier, sweet solutions (sucrose, glucose), breastfeeding, listening to the mother's voice,
singing, lullaby, aromatherapy and smelling familiar smells.
Aslan recommends the use of non-pharmacological methods to minimize the pain that occurs
during heel blood collection.
