Pain, AcuteIEWNLPCDIINNCT05103800
Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns
A study testing invasive interventions in people with Pain, Acute and Child Behavior, run by Batman University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 5 minutes to 3 hoursHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Child Behavior, Newborn
- What is being tested?
- invasive interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 minutes to 3 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies who were born by normal vaginal delivery
- Babies who were born in the delivery room of Batman Training and Research Hospital
Who cannot join
- Congenital anomalies
- Cranial hemorrhage
- Who need oxygen support
- Who have sepsis or suspected sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive
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.
Read the detailed 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.
- Conditions
- Pain, Acute, Child Behavior, Newborn
- Being tested
- invasive interventions
- Keywords
- Child Health and Nursing, Pain, Newborn, Comfort
- Medical subject headings
- Acute Pain, Child Behavior, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive interventionsBehavioural
Also called white noise
listening the white noise during the invasive interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: invasive interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Neonatal Infant Paint Scale
The Neonatal Infant Paint Scale is measured by evaluating five behavioral groupings (facial expression, crying, movements of arms and legs, alertness) and a physiological indicator (breathing pattern). Total pain scores range from 0-7. (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start15 Nov 2021
- Primary completion15 Mar 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Todi̇l, Batman University
- Investigators
- Tuğba TODIL, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103800
- Sponsor's protocol ID
- BatmanU
- Acronym
- IEWNLPCDIIN
- Status last verified
- Jul 2022
- First submitted
- 6 Sep 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive
- ClinicalTrials.gov ID
- NCT05103800
- Acronym / sponsor ID
- IEWNLPCDIIN / BatmanU
- Conditions
- Pain, Acute, Child Behavior, Newborn
- Keywords
- Child Health and Nursing, Pain, Newborn, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: invasive interventionsDuring 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. |
Who may qualify
- Ages
- 5 minutes to 3 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Babies who were born by normal vaginal delivery
- Babies who were born in the delivery room of Batman Training and Research Hospital
Key exclusion criteria (4 listed)
- Congenital anomalies
- Cranial hemorrhage
- Who need oxygen support
- Who have sepsis or suspected sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| invasive interventionsAlso: white noiselistening the white noise during the invasive interventions | Behavioural | Experimental group |
Primary outcome
Newborn Comfort Behavior Scale (COMFORTneo Behavior Scale)
Time frame: 6 months
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.
1 secondary outcome
Neonatal Infant Paint Scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba TODIL principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing invasive interventions in people with Pain, Acute and Child Behavior, run by Batman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Comfort Behavior Scale (COMFORTneo Behavior Scale) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.