''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters''

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''

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06077409
• Other study ID #: 177
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Newborns are often exposed to acute or chronic pain due to different invasive interventions (Akcan and Polat, 2017). The American Pain Society (APS) accepts pain as the fifth physiological parameter (McCharty et al., 2013). The American Academy of Pediatrics (AAP) recommends minimizing pain due to invasive procedures (Aydın et al., 2016). Reducing pain first requires accurate assessment of pain and treatment with pharmacological/non-pharmacological interventions (Hussein, 2015). Pharmacological methods have risks such as drug-related side effects. For this reason, non-pharmacological methods are primarily preferred in acute pain (Hashemi et al., 2016). Non-pharmacological methods for pain management are diverse. In recent years, non-pharmacological methods such as distraction, wrapping, positioning, aromatherapy, music, games, massage, kangaroo care, and oral sucrose have been used together or separately to reduce pain and/or stress-related behaviors (Abdallah et al., 2013). In another application, the tent-to-skin contact method, the newborn is laid face down on the parent's chest. The newborn's back is covered to prevent heat loss. It is thought that this situation will relax the newborn and therefore perceive the pain as milder (Mayfield, 2019). Gentle Human Touch is one of the therapeutic touch methods. Gentle touch, which is a simple and applicable method in newborns, is a non-invasive touch technique that does not require special equipment and technology. The gentle touch method is a sensitive tactile stimulation applied to the skin, without caressing or massage, and provides a relaxing effect on the baby (Dur et al., 2020; Fatohallazade, 2020). Newborns need their parents, especially their mothers, to be with them during all kinds of interventions. For this reason, the parent should be with the newborn during the invasive interventions and take a primary role in the non-pharmacological interventions; It provides optimum comfort for the nurse, newborn and caregiver. It is important to benefit from the family-centered care model when using non-pharmacological methods. Family-centered care is a care model based on collaboration between health professionals and children's families in the planning, delivery and evaluation of health services. Its general goal is to increase the quality of health services for children and families, increase the satisfaction of families and health professionals, and ensure the effective use of personnel (Yılmaz and Gözen, 2019). It was planned as a randomized controlled experimental design type in order to determine the importance of the family-centered care model and parents' participation in the procedures and to determine the effect of non-pharmacological methods applied to preterm newborns by their mothers on the pain occurring during blood collection and the effect on preterm physiological parameters.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Pain
• Touch
• Venipuncture

Intervention

Other:
• Skin To Skin
Skin to Skin Contact Group The temperature of the environment where kangaroo care will be carried out will be adjusted between 22-26 degrees C. The mother will be allowed to disinfect her hands and warm them until her hand temperature is at least 34 C. Only the baby's diaper, hat and socks will be left behind, and the baby will be placed face down on the mother's chest, with its head upright and its legs under the breasts in a frog position. The baby's face will be turned towards the mother and eye contact will be made. The baby will be in an upright position between the mother's breasts and skin to skin with the mother. Skin-to-skin contact will begin 5 minutes before blood collection, continue throughout the procedure, and kangaroo care will continue until 5 minutes after the procedure.

Behavioral:
• Gentle Human Touch
Experimental Group (Gentle Touch/Gentle Human Touch-GHT); After the mother is dressed in a clean apron, her hands are washed and disinfected, and it is safe to warm the hand temperature with a non-contact thermometer device until the measured value is 34 ºC. The mother, who was previously informed about the method, will be placed on the eyebrow line with the crown piece that will separate the fingertips and tuft of one hand, while the other hand will be placed on the lower abdomen, which will mark the waist and hips (Figure 1). The blood collection amount of GHT application will be started 5 minutes before, make sure that the blood collection is done and the blood collection will continue until 5 minutes later.

Locations

Country	Name	City	State
Turkey	Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital	Istanbul	Üsküdar

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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

Outcome

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

External Links

•   Akcan, E. & Polat, S. (2017). Yenidoganlarda Agri ve Agri Yönetiminde Hemsirenin Rolü. Acibadem Üniversitesi Saglik Bilimleri Dergisi, (2): 64-69
•   Mayfield, A. (2019). Effects of Kangaroo Mother Care on Mother-Infant Interaction: Infant Behaviors (Doctoral dissertation, Southeast Missouri State University).
•   WHO Preterm Birth Detail
•   Yilmaz, Ö. E., & Gözen, D. (2019). Pediatri Hemsireliginde Aile Merkezli Bakimin Önemi ve Bakim Kalitesini Gelistirmedeki Degeri. Türkiye Klinikleri Çocuk Sagligi ve Hastaliklari Hemsireligi-Özel Konular, 5(2), 5-11.