The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture

NCT05727631 | Completed

• 1 other identifier: 190
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Newborns are frequently exposed to acute or chronic pain experience due to different invasive interventions. The American Academy of Pediatrics (AAP) recommends minimizing the pain associated with invasive procedures. Reduction of pain primarily requires accurate assessment of pain, and treatment with pharmacological/nonpharmacological interventions. Touch is one of the first senses developed in the newborn. Gentle Human Touch (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 stroking or massage, and provides a relaxing effect on the baby. Studies have shown that the gentle touch method increases the sleep level of preterm infants, reduces pain, stress and cortisone levels, reduces restlessness and keeps the heart rate under control. Newborns need their parents, especially their mothers, to be by their side during any kind of intervention. For this reason, the presence of the parent next to the newborn during invasive procedures and the primary role in nonpharmacological interventions provides optimal comfort for the nurse, the newborn and the caregiver. When using nonpharmacological methods, it is important to take advantage of the family-centered care model. Family-centered care is a model of care based on cooperation between health professionals and children's families in the planning, delivery and evaluation of health Decency. Its general objective is to improve the quality of health services for children and families, to increase the satisfaction of families and health professionals, and to ensure the effective use of personnel. Accordingly, this thesis study was planned in a randomized controlled experimental design type in order to determine the importance of family-centered care model and parents' participation in the procedures and the effect of gentle touch method applied by mothers during bloodletting on preterm pain level, physiological parameters, crying time and anxiety level of the mother.

Conditions

Venipuncture; Pain

Keywords

NEWBORN; PRETERM; GENTLE HUMAN TOUCH; PAİN

Outcome Measures

Primary Outcomes (2)

• PRETERM PAİN

  Neonatal Infant Pain Scale

  AT THE FIRST MINUTE OF VENİPUNCTURE

• MOTHER'S ANXIETY

  State-Trait Anxiety Scale

  FIVE MINUTES AFTER VENIPUNCTURE

Secondary Outcomes (3)

• HEART RATE

  AT THE FIRST MINUTE OF VENİPUNCTURE

• OXYGEN SATURATION

  AT THE FIRST MINUTE OF VENİPUNCTURE

• CRYING TIME

  METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED

Study Arms (2)

gentle human touch

EXPERIMENTAL

In the study, after the mother in the experimental group was dressed in a clean apron, she was allowed to wash and disinfect her hands. When the temperature of the mother's hand was measured with a non-contact thermometer, it was allowed to warm it under a radiant heater until it reached 34 ºC. The mother, who was informed about the method before, was allowed to place the palm of one hand on the baby's crown, with her fingertips touching the eyebrow line. She placed her other hand on her lower abdomen, encircling the baby's waist and hips. It has been provided to perform sensitive touch operation without pressure and massage. The mother started the gentle touch method 5 minutes before the blood draw, and continued to do the touching during the blood draw and 5 minutes after the blood draw was finished.

Other: gentle human touch

Control group

NO INTERVENTION

The standard procedure of the clinic was applied to preterm infants in the control group. In the standard procedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure. IN ALL BABIES IN THE CONTROL AND EXPERIMENTAL GROUP., Before the procedure, 5 minutes after the procedure and 20 minutes after the procedure, the mother filled out the STAI-I form. The NIPS scale to measure the infant's pain was scored by two independent observers before, during, and five minutes after the procedure. KTA, SPO2 values of the baby were recorded before, during and five minutes after the procedure. The baby's crying time was started when the crying started, and stopped when the crying stopped.

Interventions

gentle human touch OTHER

Mother will apply gentle human touch touch technique during venous blood collection from preterm babies between 32-37 weeks of gestation

Also known as: yok

gentle human touch

Eligibility Criteria

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

You may qualify if:

• Between 32 and 37 gestational weeks,
• The first blood collection attempt is successful,
• Health follow-ups performed after childbirth are considered healthy by the physician,

You may not qualify if:

• Analgesic given up to 6 hours before the procedure,
• With a congenital anomaly, • With any disease,

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 (13)

• 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 RESULT

• Akcan, E., & Polat, S. (2017). The role of the nurse in pain and pain management in newborns. Acıbadem University Journal of Health Sciences, (2), 64-69.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Liaw JJ, Yang L, Katherine Wang KW, Chen CM, Chang YC, Yin T. Non-nutritive sucking and facilitated tucking relieve preterm infant pain during heel-stick procedures: a prospective, randomised controlled crossover trial. Int J Nurs Stud. 2012 Mar;49(3):300-9. doi: 10.1016/j.ijnurstu.2011.09.017. Epub 2011 Oct 14.

  PMID: 22001561 RESULT

• Mayfield, A. (2019). Effects of Kangaroo Mother Care on Mother-Infant Interaction: Infant Behaviors (Doctoral dissertation, Southeast Missouri State University).

  RESULT

• 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 RESULT

• Morrow C, Hidinger A, Wilkinson-Faulk D. Reducing neonatal pain during routine heel lance procedures. MCN Am J Matern Child Nurs. 2010 Nov-Dec;35(6):346-54; quiz 354-6. doi: 10.1097/NMC.0b013e3181f4fc53.

  PMID: 20926970 RESULT

• Yilmaz, O. E., & Gözen, D. (2019). The Importance of Family Centered Care in Pediatric Nursing and Its Value in Improving the Quality of Care. Turkiye Klinikleri Child Health and Diseases Nursing-Special Topics, 5(2), 5-11.

  RESULT

• Zempsky WT. Optimizing the management of peripheral venous access pain in children: evidence, impact, and implementation. Pediatrics. 2008 Nov;122 Suppl 3:S121-4. doi: 10.1542/peds.2008-1055c. No abstract available.

  PMID: 18978004 RESULT

• Kilinc D, Caglar S. The Effect of Mother's Gentle Human Touch on Preterm Neonate's Pain and Maternal Anxiety During Venipuncture in Turkiye. Res Nurs Health. 2025 Aug;48(4):487-496. doi: 10.1002/nur.22472. Epub 2025 May 20.

  PMID: 40392177 DERIVED

MeSH Terms

Conditions

Pain; Premature Birth

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• DERYA KILINÇ, 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: PhD

Model Details: Preterm babies who apply to the blood collection room to draw blood, will be included in the experimental and control group. Randomization was done at www.randomizer.org.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 14, 2023
• Study Start: June 30, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)