Orogastric Tube InsertionNCT04678570
Pain Perception Associated With Orogastric Tube Insertion in Preterm Infants
A study testing White Noise and Swaddling Method in people with Orogastric Tube Insertion, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants. This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orogastric Tube Insertion
- What is being tested?
- White Noise and Swaddling Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- With 32-34 weeks of gestation,
- With the postnatal age between 3-28 days,
- Birth weight is above 1000 grams,
- With the Apgar score ≥7 at 1st and 5th minutes,
- With stable vital signs,
- Without any congenital anomaly,
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- Not receiving mechanical ventilator support and having spontaneous breathing,
- Requested by the physician to place an orogastric tube and fed with an orogastric tube,
- Breastfeeding (through an orogastric tube),
- Not experienced a painful procedure at least half an hour before the interventions,
- Without the use of opioid or non-opioid analgesic in their treatment,
- Without congenital or acquired malformation related to hearing,
- With parents written consent for the participation of their baby.
Who cannot join
- With the postnatal age outside 3-28 days,
- Birth weight is ≤ 1000 grams,
- With the Apgar score <7 at 1st and 5th minutes,
- With unstable vital signs,
- With congenital anomaly in the face or the oral cavity,
- Being on mechanical ventilator support,
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- With a congenital malformation that may affect respiration and cause asphyxia,
- With intracranial bleeding or risk of bleeding,
- With disorders affecting the cerebral circulation or cardiovascular system,
- Subjected to a painful procedure at least half an hour before the interventions,
- With opioid or non-opioid analgesic in their treatment,
- With the surgical history,
- With continuous sedative treatment,
- With congenital or acquired malformation related to hearing,
- Not being fed with an orogastric tube,
- With parent not giving consent for the participation of their baby
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uşak Öztan Hospital Neonatal Intensive Care Unit
Uşak
About this study
Official title: The Effect of White Noise and Swaddling Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants: A Randomized Controlled Trial
This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants.
This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.
Read the detailed description
This is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants.
The study will be conducted between 01/01/2021-15/06/2021 in Usak Öztan Hospital Neonatal Intensive Care Unit.
The sample of the study is planned to have 132 participants with 33 of them in each of the 4 groups.
This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.
The interventions that will be used in this study are emphasized in the literature as nonpharmacological methods in reducing and preventing pain.
In Usak Öztan Hospital Neonatal Intensive Care Unit, where the study is planned to be conducted, a pre-application will be performed with 10 preterm infants to evaluate the effect of white noise, swaddling, white noise, and swaddling methods on pain perception in preterm infants with an orogastric tube inserted.
As the video recordings will be used for the evaluation of the pain, the best area for the video recorder to be placed will be decided during this stage.
Insertion of the orogastric tube will be done by the same nurse, who will be briefed about the study concept and will be blinded to the control and the intervention groups, to manage standardization. There will be always a specialist doctor to monitor the infants during this stage for any possible complications.
- Conditions
- Orogastric Tube Insertion
- Being tested
- White Noise, Swaddling Method
- Keywords
- Pain, Preterm birth
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White NoiseOther
The infants will be listened to a song Called " Bebeginiz Aglamasin" from Orhan Osman's colic album which was prepared with the help of Dr. Harvery Karp's ''The Happiest Baby'' album through a portable speaker located at 50 cm away from the infant at 55-decibel frequency.
Listening to this song will start 5 minutes before the insertion of the Orogastric Tube, will continue during the procedure and another 5 more minutes after the procedure is completed. The rest of the noise in the environment will be controlled.
Swaddling MethodOther
The preterm infants will be placed in the supine position on a 90 cm2 soft cloth. The upper edge of the cloth will be aligned with the infant's shoulder, with the arms placed close to the body, with the horizontal ends of the cloth folded in the opposite direction to cover the top of the body. The arms will be put into flexion and the body will be covered with a cloth. In order not to limit the movements of all limbs of the preterm infant, attention will be paid to leave a finger space between the infant and the cloth cover and to leave a suitable space for the feet to be comfortable before folding the lower part of the cloth cover forward. In the swaddling method, the baby's head can move freely. The swaddling method will be applied approximately 5-10 minutes before the procedure and will be removed from the infant 5 minutes after the procedure. Because swaddling will increase the body temperature of the infant, the standard temperature of the incubator will be lowered.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group-1 | Experimental | White Noise intervention and standard care, procedures will be applied. Receives: Other: White Noise |
| Intervention Group- 2 | Experimental | The swaddling method and standard care, procedures will be applied. Receives: Other: Swaddling Method |
| Intervention Group- 3 | Experimental | White Noise, swaddling method, and standard care, procedures will be applied. Receives: Other: White Noise; Other: Swaddling Method |
| No Intervention Group | No intervention | Standard care and procedures to be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premature Infant Pain Profile-Revised (PIPP-R) Change
The PIPP-R scale includes 3 behavioral (brow bulge, eye squeeze, nasolabial-furrow), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. Each item has a score from 0-3. The highest score that can be obtained from the PIPP-R scale for preterm infants is 21.The mean scores obtained from the PIPP-R scale reflects mild level of pain as mild if it is between 0-6 points, moderate if it is between 7-12 points and severe if it is between 13-21 points.
Measured: 5 minutes, 3 minutes and 1 minute before the procedure. During the procedure. 1 minute, 3 minutes and 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2021
- Primary completion1 May 2022
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orogastric Tube InsertionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÖZNUR GÜRLEK KISACIK, Afyonkarahisar Health Sciences University
- Investigators
- Öznur GÜRLEK KISACIK, Phd, Study director, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678570
- Sponsor's protocol ID
- 2020-467
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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
- The Effect of White Noise and Swaddling Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04678570
- Acronym / sponsor ID
- 2020-467
- Conditions
- Orogastric Tube Insertion
- Keywords
- Pain, Preterm birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 22 Dec 2020 (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.
This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants.
This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.
Detailed description
This is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants.
The study will be conducted between 01/01/2021-15/06/2021 in Usak Öztan Hospital Neonatal Intensive Care Unit.
The sample of the study is planned to have 132 participants with 33 of them in each of the 4 groups.
This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.
The interventions that will be used in this study are emphasized in the literature as nonpharmacological methods in reducing and preventing pain.
In Usak Öztan Hospital Neonatal Intensive Care Unit, where the study is planned to be conducted, a pre-application will be performed with 10 preterm infants to evaluate the effect of white noise, swaddling, white noise, and swaddling methods on pain perception in preterm infants with an orogastric tube inserted.
As the video recordings will be used for the evaluation of the pain, the best area for the video recorder to be placed will be decided during this stage.
Insertion of the orogastric tube will be done by the same nurse, who will be briefed about the study concept and will be blinded to the control and the intervention groups, to manage standardization. There will be always a specialist doctor to monitor the infants during this stage for any possible complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Group-1 | Experimental | Other: White NoiseWhite Noise intervention and standard care, procedures will be applied. |
| Intervention Group- 2 | Experimental | Other: Swaddling MethodThe swaddling method and standard care, procedures will be applied. |
| Intervention Group- 3 | Experimental | Other: White Noise, Other: Swaddling MethodWhite Noise, swaddling method, and standard care, procedures will be applied. |
| No Intervention Group | No intervention | –Standard care and procedures to be applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- With 32-34 weeks of gestation,
- With the postnatal age between 3-28 days,
- Birth weight is above 1000 grams,
- With the Apgar score ≥7 at 1st and 5th minutes,
- With stable vital signs,
Key exclusion criteria (16 listed)
- With the postnatal age outside 3-28 days,
- Birth weight is ≤ 1000 grams,
- With the Apgar score <7 at 1st and 5th minutes,
- With unstable vital signs,
- With congenital anomaly in the face or the oral cavity,
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 |
|---|---|---|
| White NoiseThe infants will be listened to a song Called " Bebeginiz Aglamasin" from Orhan Osman's colic album which was prepared with the help of Dr. Harvery Karp's ''The Happiest Baby'' album through a portable speaker located at 50 cm away from the infant at 55-decibel frequency. Listening to this song will start 5 minutes before the insertion of the Orogastric Tube, will continue during the procedure and another 5 more minutes after the procedure is completed. The rest of the noise in the environment will be controlled. | Other | Intervention Group- 3, Intervention Group-1 |
| Swaddling MethodThe preterm infants will be placed in the supine position on a 90 cm2 soft cloth. The upper edge of the cloth will be aligned with the infant's shoulder, with the arms placed close to the body, with the horizontal ends of the cloth folded in the opposite direction to cover the top of the body. The arms will be put into flexion and the body will be covered with a cloth. In order not to limit the movements of all limbs of the preterm infant, attention will be paid to leave a finger space between the infant and the cloth cover and to leave a suitable space for the feet to be comfortable before folding the lower part of the cloth cover forward. In the swaddling method, the baby's head can move freely. The swaddling method will be applied approximately 5-10 minutes before the procedure and will be removed from the infant 5 minutes after the procedure. Because swaddling will increase the body temperature of the infant, the standard temperature of the incubator will be lowered. | Other | Intervention Group- 2, Intervention Group- 3 |
Primary outcome
The Premature Infant Pain Profile-Revised (PIPP-R) Change
Time frame: 5 minutes, 3 minutes and 1 minute before the procedure. During the procedure. 1 minute, 3 minutes and 5 minutes after the procedure
The PIPP-R scale includes 3 behavioral (brow bulge, eye squeeze, nasolabial-furrow), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. Each item has a score from 0-3. The highest score that can be obtained from the PIPP-R scale for preterm infants is 21.The mean scores obtained from the PIPP-R scale reflects mild level of pain as mild if it is between 0-6 points, moderate if it is between 7-12 points and severe if it is between 13-21 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Intubated Patient Requiring a Gastric Tube
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.
Öznur GÜRLEK KISACIK, Phd study director
Afyonkarahisar Health Sciences 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 White Noise and Swaddling Method in people with Orogastric Tube Insertion, run by Afyonkarahisar Health Sciences 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 13 inclusion and 16 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: status not confirmed, 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?
Results are not available in the source record.
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?
The Premature Infant Pain Profile-Revised (PIPP-R) Change (time frame: 5 minutes, 3 minutes and 1 minute before the procedure. During the procedure. 1 minute, 3 minutes and 5 minutes after the procedure). 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.