Infant, NewbornNCT05051267
Evaluation of the Effectiveness of Non-pharmacological Methods During Heel Blood Collection
A study testing Non-Pharmacological Methods in people with Infant, Newborn, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Read more about this study
- Who is it for?
- Ages 1 day to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn
- What is being tested?
- Non-Pharmacological Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 Jan 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 1 day to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns postnatal age is between 1-5 days,
- 37-42. newborns born between gestational weeks,
- Newborns are healthy,
- Babies of mothers without diabetes,
- Newborns were not given any opioid and non-opioid drugs before the application,
- Newborns have been fed at least 30 minutes ago,
Show all 9Show fewer
- Newborns without any painful interventions other than vitamin K and Hepatitis B injections will be included.
- Mothers can speak and understand Turkish,
- Babies of mothers accepted to participate in the study and written consent form was obtained from them will be included in the study.
Who cannot join
- Connected to mechanical ventilator,
- Having a neurological disorder,
- Congenital anomaly,
- Having hyperglycemia,
- Having undergone a surgical procedure,
- The baby of a mother is addicted to drugs,
- If the lancet cannot be inserted and removed at once, the baby will be excluded from the study.
- Infants, despite meeting the criteria, will be excluded from the study if the heel blood collection takes more than 2 minutes in total, the procedure is disrupted by someone entering the room loudly, or the mother changes the position of the baby.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Mother's Voice, Mothers Embrace and White Noise Methods During Heel Blood Collection
Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are cheap, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
Read the detailed description
Pain is known to affect individuals of all ages. However, until the 1980s, it was widely believed that newborns were inadequate in perceiving and interpreting pain because their nervous system was not fully developed. Studies conducted after these years have shown that the fetus has all the anatomical structures and functions of the peripheral and central nervous system necessary to perceive and interpret pain from the 20th week. After this information, this issue started to be given more importance in newborns. The most important reason for this is that term and preterm newborns staying in neonatal units experience pain for numerous and very different reasons.
Heel blood sampling, which is widely used for the diagnosis and follow-up of various diseases, causes acute pain in infants. Heel blood collection is more painful than venous blood collection, squeezing is another factor that causes pain. There is not enough data on the chronicity of pain after these procedures. However, the inability to control pain in newborns followed for a long time in health centers increases the risk of chronic pain.
It has been observed that the pain sensitivity of babies who were followed up in the neonatal period and exposed to painful procedures changed in the next period. Therefore, it is very important to measure the infant's perception of pain in order to investigate the causes, mechanisms, and effects of pain. The pain response is very difficult to understand because newborns cannot express themselves verbally. Observation of hormonal, behavioral, and metabolic changes in the body due to pain provides data on the level of response to pain and the effectiveness of treatment. Evaluation of the pain response in the newborn is performed to reveal the pain state, to determine the level of pain, and to understand whether there is a need for intervention. In the routine operation of health centers, it is necessary to give due importance to the evaluation of pain response. It is important to observe the pain conditions as well as the basic vital functions of babies. It has been shown that repetitive heel blood sampling increases sensitivity to pain and decreases the pain threshold. In the light of these findings, it is thought that the heel puncture procedure to collect blood from the heel in the newborn period will have a negative effect on the pain response of the baby in the long term. Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are inexpensive, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study in order to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
- Conditions
- Infant, Newborn
- Being tested
- Non-Pharmacological Methods
- Keywords
- Newborn, Pain, Mother's voice, White noise, Mother Embrace
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Pharmacological MethodsOther
All of the applications that increase the effectiveness of drugs when used together with analgesics and provide the elimination of pain by releasing our body's natural morphine and endorphins without the use of analgesics are called non-pharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care Group | No intervention | Before the application, the families will be informed by the researcher and the 'Informed Consent Form' will be signed. After the heel blood procedure, comfort will be provided with gentle touches. For ethical reasons, routine care will be provided when the baby cries. |
| Mothers Embrace | Experimental | A mothers embrace is one of the earliest and most common care events that mothers offer to their babies. Close physical contact between mother and baby during hugs can reduce stress by facilitating co-regulation of mother and baby. In a study conducted in Turkey, it was stated that holding the baby on the lap for pain relief in painful interventions is a practical and easy method. Receives: Other: Non-Pharmacological Methods |
| White Noise | Experimental | Since white noise is a humming and continuous monotonous sound, it is similar to the sound in the womb (Balci, 2006). It will be explained that this sound is very similar to the sound that the baby hears in the mother's womb by making the white noise recordings listen to the mothers who will have their babies listen to white noise. by Orhan Osman; Dr. From the album 'Kolik', which was created by making use of the album 'The Happiest Baby' prepared by Harvery Karp, which consists only of uterus sounds; The song 'Don't Let Your Baby Cry, PT.2' will be played to babies (Karp, 2015). In addition, infants will be excluded from the study even though they meet the criteria, if they are not sedated, the procedure takes more than 2 minutes, the procedure is disrupted because someone enters the room loudly, or the mother changes the baby's position (Karakoç, \& Türker, 2014). Receives: Other: Non-Pharmacological Methods |
| Mother's Voice | Experimental | Auditory responses, fetal age 26-28. It develops in the auditory cortex and brain stem in weeks (Eskandari, Keshavarz, \& Jahdi, 2010). Hearing is one of the first senses a fetus develops and is 24-33. can recognize and remember the mother's voice after weeks (Djordjevic, 2010 ). The fetus memorizes the musical characteristics of the mother's voice, like tone, by listening to it (Arabin, 2002). It is stated that newborns exposed to their own mother's voice have a lower heart rate, higher sucking rate, a more relaxed appearance, and less crying and body movements (Campbell-Yeo, Fernandes, \& Johnston, 2011). Receives: Other: Non-Pharmacological Methods |
| Mothers Embrace and White Noise Applied Group | Experimental | One minute after the procedure, the baby's pain score will be evaluated. After the procedure, until the baby returns to basal values, the mother will be asked to hold her baby and the white noise will continue to be listened to. Video and audio recording will continue until the baby's oxygen saturation and heart rate return to pre-procedural basal values. When it returns to basal values, the baby's pain score will be re-evaluated. Receives: Other: Non-Pharmacological Methods |
| Mothers Embrace and Mother's Voice Group | Experimental | After the procedure, the baby will continue to listen to the baby who is in the mother's arms. One minute after the procedure, the baby's pain score will be evaluated and the HR and O2 values will be noted. After the procedure, until the baby returns to basal values, the mother will be asked to hold her baby and the mother's voice will continue to be listened to. Video and audio recording will continue until the baby's oxygen saturation and heart rate return to basal values. When it returns to basal values, the baby's pain score will be re-evaluated. Receives: Other: Non-Pharmacological Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Results
Premature Infant Pain Profile Scale (PIPP)
PIPP assesses pain with seven indicators. these; three behavioral (forehead wrinkling, squinting eyes, and widening of the nose wings), two physiological (heart rate and oxygen saturation), and two contextual (week of gestation and sleep/wake status) variables (Stevens et al., 1996). Within the scope of the PIPP scale; gestational week, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting eyes, and nose There are 7 items such as expansion on the wings. Each item; is scored as 0, 1, 2, and 3 from best to worst. Premature Infant Pain Profile Scale; Pain is considered mild between 0-6 points, moderate between 7-12 points, and severe between 13-21 points.
Measured: 1 year
Pain Results
Neonatal Infant Pain Scale (NIPS)
NIPS was developed to assess acute pain. It was developed by Lawrence et al. in 1993. Scoring in NIPS is made according to six categories. These; facial expression, crying, breathing pattern, arms, legs, and alertness. Crying category, three separate points (0-1-2) while others are evaluated with two separate points (0-1). The total score varies between 0-7. The lowest score is "0", while the most severe pain score is "7".
Lawrence, J., Alcock, D., McGrath, P., Kay, J., MacMurray, S., \& Dulberry, C. The development of a tool to assess neonatal pain. 1993; 2(6), 59-66
Measured: 1 year
Secondary outcomes (4)
Physiological Parameters
Oxygen saturation Oxygen values of the newborn before, during and after the procedure
Measured: 1 year
Physiological Parameters
Crying Time The baby's crying time will be noted after receiving heel blood.
Measured: 1 year
Physiological Parameters
Heart Rate Peak Values will be noted by the researcher 1 minute before the procedure, during the heel blood procedure and 1 minute after the procedure.
Measured: 1 year
Physiological Parameters
Basal Values Time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Mar 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur Gül, Akdeniz University
- Investigators
- Uğur Gül, Principal investigator, Akdeniz University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051267
- Sponsor's protocol ID
- 70904504/43
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sharing plans for the current study are unknown and will be made available at a later date
Publications
Campbell-Yeo M, Fernandes A, Johnston C. Procedural pain management for neonates using nonpharmacological strategies: part 2: mother-driven interventions. Adv Neonatal Care. 2011 Oct;11(5):312-8; quiz pg 319-20. doi: 10.1097/ANC.0b013e318229aa76.
PubMed 22123399Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
PubMed 16580851Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
PubMed 32062050Hermann C, Hohmeister J, Demirakca S, Zohsel K, Flor H. Long-term alteration of pain sensitivity in school-aged children with early pain experiences. Pain. 2006 Dec 5;125(3):278-285. doi: 10.1016/j.pain.2006.08.026. Epub 2006 Oct 2.
PubMed 17011707Kahraman A, Gumus M, Akar M, Sipahi M, Bal Yilmaz H, Basbakkal Z. The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial. Intensive Crit Care Nurs. 2020 Dec;61:102904. doi: 10.1016/j.iccn.2020.102904. Epub 2020 Jul 9.
PubMed 32653359Karakoc A, Turker F. Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20.
PubMed 24559599Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.
PubMed 27751753Leng HY, Zheng XL, Zhang XH, He HY, Tu GF, Fu Q, Shi SN, Yan L. Combined non-pharmacological interventions for newborn pain relief in two degrees of pain procedures: A randomized clinical trial. Eur J Pain. 2016 Jul;20(6):989-97. doi: 10.1002/ejp.824. Epub 2015 Dec 18.
PubMed 26685099Neu M, Robinson J, Schmiege SJ. Influence of holding practice on preterm infant development. MCN Am J Matern Child Nurs. 2013 May-Jun;38(3):136-43. doi: 10.1097/NMC.0b013e31827ca68c.
PubMed 23625100Ahmadi M, Toghyani R, Shahidi S, Izadi M, Merasi MR, Agdak P, Meshkaty M, Nikkhahfard M. The study of Prevalence of Antigen HBs Positive and High-risk Behaviors in Pregnant Women Referring to Urban Health Centers of Isfahan Province in 2009. Iran J Nurs Midwifery Res. 2011 Winter;16(1):1-8.
PubMed 21772915Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
PubMed 8722730Walter-Nicolet E, Annequin D, Biran V, Mitanchez D, Tourniaire B. Pain management in newborns: from prevention to treatment. Paediatr Drugs. 2010 Dec 1;12(6):353-65. doi: 10.2165/11318900-000000000-00000.
PubMed 21028915Yin T, Yang L, Lee TY, Li CC, Hua YM, Liaw JJ. Development of atraumatic heel-stick procedures by combined treatment with non-nutritive sucking, oral sucrose, and facilitated tucking: a randomised, controlled trial. Int J Nurs Stud. 2015 Aug;52(8):1288-99. doi: 10.1016/j.ijnurstu.2015.04.012. Epub 2015 Apr 23.
PubMed 25939641Anand KJ, Coskun V, Thrivikraman KV, Nemeroff CB, Plotsky PM. Long-term behavioral effects of repetitive pain in neonatal rat pups. Physiol Behav. 1999 Jun;66(4):627-37. doi: 10.1016/s0031-9384(98)00338-2.
PubMed 10386907
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Mother's Voice, Mothers Embrace and White Noise Methods During Heel Blood Collection
- ClinicalTrials.gov ID
- NCT05051267
- Acronym / sponsor ID
- 70904504/43
- Conditions
- Infant, Newborn
- Keywords
- Newborn, Pain, Mother's voice, White noise, Mother Embrace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 21 Sep 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.
Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are cheap, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
Detailed description
Pain is known to affect individuals of all ages. However, until the 1980s, it was widely believed that newborns were inadequate in perceiving and interpreting pain because their nervous system was not fully developed. Studies conducted after these years have shown that the fetus has all the anatomical structures and functions of the peripheral and central nervous system necessary to perceive and interpret pain from the 20th week. After this information, this issue started to be given more importance in newborns. The most important reason for this is that term and preterm newborns staying in neonatal units experience pain for numerous and very different reasons.
Heel blood sampling, which is widely used for the diagnosis and follow-up of various diseases, causes acute pain in infants. Heel blood collection is more painful than venous blood collection, squeezing is another factor that causes pain. There is not enough data on the chronicity of pain after these procedures. However, the inability to control pain in newborns followed for a long time in health centers increases the risk of chronic pain.
It has been observed that the pain sensitivity of babies who were followed up in the neonatal period and exposed to painful procedures changed in the next period. Therefore, it is very important to measure the infant's perception of pain in order to investigate the causes, mechanisms, and effects of pain. The pain response is very difficult to understand because newborns cannot express themselves verbally. Observation of hormonal, behavioral, and metabolic changes in the body due to pain provides data on the level of response to pain and the effectiveness of treatment. Evaluation of the pain response in the newborn is performed to reveal the pain state, to determine the level of pain, and to understand whether there is a need for intervention. In the routine operation of health centers, it is necessary to give due importance to the evaluation of pain response. It is important to observe the pain conditions as well as the basic vital functions of babies. It has been shown that repetitive heel blood sampling increases sensitivity to pain and decreases the pain threshold. In the light of these findings, it is thought that the heel puncture procedure to collect blood from the heel in the newborn period will have a negative effect on the pain response of the baby in the long term. Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are inexpensive, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study in order to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Routine Care Group | No intervention | –Before the application, the families will be informed by the researcher and the 'Informed Consent Form' will be signed. After the heel blood procedure, comfort will be provided with gentle touches. For ethical reasons, routine care will be provided when the baby cries. |
| Mothers Embrace | Experimental | Other: Non-Pharmacological MethodsA mothers embrace is one of the earliest and most common care events that mothers offer to their babies. Close physical contact between mother and baby during hugs can reduce stress by facilitating co-regulation of mother and baby. In a study conducted in Turkey, it was stated that holding the baby on the lap for pain relief in painful interventions is a practical and easy method. |
| White Noise | Experimental | Other: Non-Pharmacological MethodsSince white noise is a humming and continuous monotonous sound, it is similar to the sound in the womb (Balci, 2006). It will be explained that this sound is very similar to the sound that the baby hears in the mother's womb by making the white noise recordings listen to the mothers who will have their babies listen to white noise. by Orhan Osman; Dr. From the album 'Kolik', which was created by making use of the album 'The Happiest Baby' prepared by Harvery Karp, which consists only of uterus sounds; The song 'Don't Let Your Baby Cry, PT.2' will be played to babies (Karp, 2015). In addition, infants will be excluded from the study even though they meet the criteria, if they are not sedated, the procedure takes more than 2 minutes, the procedure is disrupted because someone enters the room loudly, or the mother changes the baby's position (Karakoç, \& Türker, 2014). |
| Mother's Voice | Experimental | Other: Non-Pharmacological MethodsAuditory responses, fetal age 26-28. It develops in the auditory cortex and brain stem in weeks (Eskandari, Keshavarz, \& Jahdi, 2010). Hearing is one of the first senses a fetus develops and is 24-33. can recognize and remember the mother's voice after weeks (Djordjevic, 2010 ). The fetus memorizes the musical characteristics of the mother's voice, like tone, by listening to it (Arabin, 2002). It is stated that newborns exposed to their own mother's voice have a lower heart rate, higher sucking rate, a more relaxed appearance, and less crying and body movements (Campbell-Yeo, Fernandes, \& Johnston, 2011). |
| Mothers Embrace and White Noise Applied Group | Experimental | Other: Non-Pharmacological MethodsOne minute after the procedure, the baby's pain score will be evaluated. After the procedure, until the baby returns to basal values, the mother will be asked to hold her baby and the white noise will continue to be listened to. Video and audio recording will continue until the baby's oxygen saturation and heart rate return to pre-procedural basal values. When it returns to basal values, the baby's pain score will be re-evaluated. |
| Mothers Embrace and Mother's Voice Group | Experimental | Other: Non-Pharmacological MethodsAfter the procedure, the baby will continue to listen to the baby who is in the mother's arms. One minute after the procedure, the baby's pain score will be evaluated and the HR and O2 values will be noted. After the procedure, until the baby returns to basal values, the mother will be asked to hold her baby and the mother's voice will continue to be listened to. Video and audio recording will continue until the baby's oxygen saturation and heart rate return to basal values. When it returns to basal values, the baby's pain score will be re-evaluated. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Newborns postnatal age is between 1-5 days,
- 37-42. newborns born between gestational weeks,
- Newborns are healthy,
- Babies of mothers without diabetes,
- Newborns were not given any opioid and non-opioid drugs before the application,
Key exclusion criteria (8 listed)
- Connected to mechanical ventilator,
- Having a neurological disorder,
- Congenital anomaly,
- Having hyperglycemia,
- Having undergone a surgical procedure,
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 |
|---|---|---|
| Non-Pharmacological MethodsAll of the applications that increase the effectiveness of drugs when used together with analgesics and provide the elimination of pain by releasing our body's natural morphine and endorphins without the use of analgesics are called non-pharmacological treatment. | Other | Mother's Voice, Mothers Embrace, Mothers Embrace and Mother's Voice Group, Mothers Embrace and White Noise Applied Group, White Noise |
Primary outcome
Pain Results
Time frame: 1 year
Premature Infant Pain Profile Scale (PIPP) PIPP assesses pain with seven indicators. these; three behavioral (forehead wrinkling, squinting eyes, and widening of the nose wings), two physiological (heart rate and oxygen saturation), and two contextual (week of gestation and sleep/wake status) variables (Stevens et al., 1996). Within the scope of the PIPP scale; gestational week, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting eyes, and nose There are 7 items such as expansion on the wings. Each item; is scored as 0, 1, 2, and 3 from best to worst. Premature Infant Pain Profile Scale; Pain is considered mild between 0-6 points, moderate between 7-12 points, and severe between 13-21 points.
Pain Results
Time frame: 1 year
Neonatal Infant Pain Scale (NIPS) NIPS was developed to assess acute pain. It was developed by Lawrence et al. in 1993. Scoring in NIPS is made according to six categories. These; facial expression, crying, breathing pattern, arms, legs, and alertness. Crying category, three separate points (0-1-2) while others are evaluated with two separate points (0-1). The total score varies between 0-7. The lowest score is "0", while the most severe pain score is "7". Lawrence, J., Alcock, D., McGrath, P., Kay, J., MacMurray, S., \& Dulberry, C. The development of a tool to assess neonatal pain. 1993; 2(6), 59-66
4 secondary outcomes
Physiological Parameters
Time frame: 1 year
Physiological Parameters
Time frame: 1 year
Physiological Parameters
Time frame: 1 year
Physiological Parameters
Time frame: 1 year
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 4 May 2022.
- Background: PubMed 22123399Campbell-Yeo M, Fernandes A, Johnston C. Procedural pain management for neonates using nonpharmacological strategies: part 2: mother-driven interventions. Adv Neonatal Care. 2011 Oct;11(5):312-8; quiz pg 319-20. doi: 10.1097/ANC.0b013e318229aa76.
- Background: PubMed 16580851Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
- Background: PubMed 32062050Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
- Background: PubMed 17011707Hermann C, Hohmeister J, Demirakca S, Zohsel K, Flor H. Long-term alteration of pain sensitivity in school-aged children with early pain experiences. Pain. 2006 Dec 5;125(3):278-285. doi: 10.1016/j.pain.2006.08.026. Epub 2006 Oct 2.
- Background: PubMed 32653359Kahraman A, Gumus M, Akar M, Sipahi M, Bal Yilmaz H, Basbakkal Z. The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial. Intensive Crit Care Nurs. 2020 Dec;61:102904. doi: 10.1016/j.iccn.2020.102904. Epub 2020 Jul 9.
- Background: PubMed 24559599Karakoc A, Turker F. Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20.
- Background: PubMed 27751753Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.
- Background: PubMed 26685099Leng HY, Zheng XL, Zhang XH, He HY, Tu GF, Fu Q, Shi SN, Yan L. Combined non-pharmacological interventions for newborn pain relief in two degrees of pain procedures: A randomized clinical trial. Eur J Pain. 2016 Jul;20(6):989-97. doi: 10.1002/ejp.824. Epub 2015 Dec 18.
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- Background: PubMed 21772915Ahmadi M, Toghyani R, Shahidi S, Izadi M, Merasi MR, Agdak P, Meshkaty M, Nikkhahfard M. The study of Prevalence of Antigen HBs Positive and High-risk Behaviors in Pregnant Women Referring to Urban Health Centers of Isfahan Province in 2009. Iran J Nurs Midwifery Res. 2011 Winter;16(1):1-8.
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- Individual participant dataSharing planned: No. The data sharing plans for the current study are unknown and will be made available at a later date
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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.
Uğur Gül principal investigator
Akdeniz University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Pharmacological Methods in people with Infant, Newborn, run by Akdeniz 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 9 inclusion and 8 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 4 May 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?
Pain Results (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051267, which also lists 14 linked publications.
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 4 May 2022.