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

NCT06077409 | Completed

• 1 other identifier: 177
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venipuncture; Pain; Touch

Keywords

pain; pretem; physiological findings; gentle human touch; skin to skin; touch

Outcome Measures

Primary Outcomes (2)

• Preterm Pain

  Neonatal İnfant Pain Scale

  5 minutes. At the first mınute of venipuncture Scores will be given between 0-7 points.

• Preterm Crying

  Stopwatch

  5 mınutes. During blood collection, the stopwatch will turn on when the baby starts crying and turn off when the baby stops crying.

Secondary Outcomes (2)

• Heart Rate

  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

• Oxygen Saturatıon

  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

Study Arms (3)

Gentle Human Touch Group

ACTIVE COMPARATOR

After the mother is dressed in a clean apron, she will be provided to wash and disinfect her hands and heat her hand temperature with a non-contact fire meter device until the measurement value is 34 ºC.Jul. The mother, who was previously informed about the method, will place the fingertips and palm of one hand above the eyebrow line so that it touches the baby's crown part, while placing the other hand on the lower abdomen surrounding the baby's waist and hips (Figure 1). The GHT application will be started 5 minutes before the blood collection procedure, it will be continued during the blood collection procedure and until 5 minutes after the end of the blood collection procedure.

Behavioral: Gentle Human Touch

Skin to Skin Group

ACTIVE COMPARATOR

The temperature of the environment where skin to skin 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 skin to skin will continue until 5 minutes after the procedure.

Other: Skin To Skin

Control Group

NO INTERVENTION

The standard procedure of the clinic was applied to preterm infants in the control group. In the standart prosedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure.

Interventions

Skin To Skin OTHER

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.

Skin to Skin Group

Gentle Human Touch BEHAVIORAL

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.

Gentle Human Touch Group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital

Istanbul, Üsküdar, 34100, Turkey (Türkiye)

Location

Related 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.

  PMID: 23932956 BACKGROUND

• 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.

  PMID: 27112434 BACKGROUND

• 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.

  PMID: 36801626 BACKGROUND

• 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.

  PMID: 26324876 BACKGROUND

• 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.

  PMID: 32601011 BACKGROUND

• 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.

  PMID: 32316790 BACKGROUND

• 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.

  PMID: 26856517 BACKGROUND

• 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.

  PMID: 22416039 BACKGROUND

• 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.

  PMID: 37033163 BACKGROUND

• 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.

  PMID: 29100198 BACKGROUND

Related Links

• Akcan, E. \& Polat, S. (2017). Yenidoğanlarda Ağrı ve Ağrı Yönetiminde Hemşirenin Rolü. Acıbadem Üniversitesi Sağlık 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
• Yılmaz, Ö. E., \& Gözen, D. (2019). Pediatri Hemşireliğinde Aile Merkezli Bakımın Önemi ve Bakım Kalitesini Geliştirmedeki Değeri. Türkiye Klinikleri Çocuk Sağlığı ve Hastalıkları Hemşireliği-Özel Konular, 5(2), 5-11.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Derya Kılınç, 1

  Istanbul Cerrahpaşa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Model Details: Premature babies who apply to the blood collection room to take blood, were included in the gentle human touch, skin to skin and control groups. Randomization occurred on: www.randomizer.org

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 11, 2023
• Study Start: February 17, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)