Pain Clinical Trial
Official title:
''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters''
NCT number | NCT06077409 |
Other study ID # | 177 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 17, 2022 |
Est. completion date | July 30, 2022 |
Verified date | October 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
37. babies under the gestational week are considered preterm babies, and babies between 32-37 gestational weeks are considered late preterm babies (WHO, 2023). Dec. While the preterm birth rate in the world is 10%, this rate is 13% in Turkey. The life rate of preterm babies has increased in recent years and they are subjected to many painful interventions for diagnosis, treatment and preventive purposes. At the time of birth, they experience painful interventions such as vitamin K, hepatitis B vaccine administration, heel blood collection. Painful interventions cause an increase in cortisol levels, resulting in impaired blood sugar in infants, impaired brain development, impaired growth and development (Akyildiz et al., 2023). In the short term, they may give signs of a decrease in oxygen saturation, an increase in heart rate, metabolic acidosis( Akcan et al., 2017). Procedural pain management is also important for the neurological development of preterm infants (Perg et al., 2018). For these reasons, the pain of the newborn due to interventional procedures should be managed well.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 30, 2022 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 32 Weeks to 37 Weeks |
Eligibility | Inclusion Criteria: - Mothers who volunteer to participate in the research, - Between 32-37 weeks of gestation, - No analgesics are given until 6 hours before the procedure, - First blood draw attempt is successful, - Those who are considered healthy by the physician in the health follow-ups performed after birth Exclusion Criteria: - Those with congenital anomalies, - Having any disease, - Patients whose intravenous blood collection attempt takes more than two minutes, - Babies previously monitored in the Neonatal Intensive Care Unit will be excluded from the scope of the research. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital | Istanbul | Üsküdar |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Abdallah B, Badr LK, Hawwari M. The efficacy of massage on short and long term outcomes in preterm infants. Infant Behav Dev. 2013 Dec;36(4):662-9. doi: 10.1016/j.infbeh.2013.06.009. Epub 2013 Aug 7. — View Citation
Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26. — View Citation
Ayyildiz TK, Tanriverdi E, Tank DY, Akkoc B, Topan A. The effect of swaddling method applied to preterm infants during the aspiration procedure on pain. J Pediatr Nurs. 2023 May-Jun;70:61-67. doi: 10.1016/j.pedn.2022.05.025. Epub 2023 Feb 18. — View Citation
Baley J; COMMITTEE ON FETUS AND NEWBORN. Skin-to-Skin Care for Term and Preterm Infants in the Neonatal ICU. Pediatrics. 2015 Sep;136(3):596-9. doi: 10.1542/peds.2015-2335. — View Citation
Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102886. Epub 2020 Jun 27. — View Citation
Fatollahzade M, Parvizi S, Kashaki M, Haghani H, Alinejad-Naeini M. The effect of gentle human touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units: a randomized controlled crossover study. J Matern Fetal Neonatal Med. 2022 Apr;35(7):1370-1376. doi: 10.1080/14767058.2020.1755649. Epub 2020 Apr 21. — View Citation
Hashemi F, Taheri L, Ghodsbin F, Pishva N, Vossoughi M. Comparing the effect of swaddling and breastfeeding and their combined effect on the pain induced by BCG vaccination in infants referring to Motahari Hospital, Jahrom, 2010-2011. Appl Nurs Res. 2016 Feb;29:217-21. doi: 10.1016/j.apnr.2015.05.013. Epub 2015 May 30. — View Citation
McCarthy M, Glick R, Green J, Plummer K, Peters K, Johnsey L, Deluca C. Comfort First: an evaluation of a procedural pain management programme for children with cancer. Psychooncology. 2013 Apr;22(4):775-82. doi: 10.1002/pon.3061. Epub 2012 Mar 13. — View Citation
Pavlyshyn H, Sarapuk I. Skin-to-skin contact-An effective intervention on pain and stress reduction in preterm infants. Front Pediatr. 2023 Mar 22;11:1148946. doi: 10.3389/fped.2023.1148946. eCollection 2023. — View Citation
Peng HF, Yin T, Yang L, Wang C, Chang YC, Jeng MJ, Liaw JJ. Non-nutritive sucking, oral breast milk, and facilitated tucking relieve preterm infant pain during heel-stick procedures: A prospective, randomized controlled trial. Int J Nurs Stud. 2018 Jan;77:162-170. doi: 10.1016/j.ijnurstu.2017.10.001. Epub 2017 Oct 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preterm Pain | Neonatal Infant Pain Scale | 5 minutes. At the first minute of venipuncture Scores will be given between 0-7 points. | |
Primary | Preterm Crying | Stopwatch | 5 minutes. During blood collection, the stopwatch will turn on when the baby starts crying and turn off when the baby stops crying. | |
Secondary | Heart Rate | Measured 3 times in total | 1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure | |
Secondary | Oxygen Saturation | Measured 3 times in total | 1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure |
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