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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05727631
Other study ID # 190
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

June December 2021-Dec 2021, the universe of the research will consist of preterm infants and mothers admitted to Istanbul Zeynep Kamil Women and Children's Diseases Training and Research Hospital Neonatal Outpatient Clinic. The sample will be composed of mothers and preterm infants who have undergone bloodletting between these dates, who meet the sample selection criteria, and who volunteer to participate in the study Dec. At the beginning of the data collection phase, power analysis will be performed to determine the number of samples. Groups of babies will be determined using simple randomization method in computer environment. Data Collection Process After obtaining the permissions of the ethics committee and the institution of the research, the subject and purpose of the research will be explained to all medical personnel working in the neonatal outpatient clinic of the hospital where the research will be conducted, and the methods to be applied in the research will be explained. After the parents of the babies who meet the case selection criteria are informed about the research, their oral and written consents will be obtained through the "Informed Consent Form". It will be determined by computerized simple randomization method which mothers and their babies who are willing to participate in the research and who meet the sample selection criteria will be included in which group (www.randomizer.org ). The experimental group and the control group will be fitted with a pulse oximeter device 5 minutes before the start of the blood collection procedure and it will be ensured that it is attached until 5 minutes after the procedure. 5 Minutes before the procedure, the procedure sequence and 5 minutes after the procedure, the baby's pain score, the number of heart beats, the oxygen saturation value and the mother's anxiety level will be recorded. The crying time will be recorded as the time elapsed from the moment the baby starts crying until the crying ends. All measurements will be measured by two independent observers and recorded in the observation form. The blood collection procedure will be performed by the same nurse in each of the 2 groups.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 32 Weeks to 37 Weeks
Eligibility Inclusion Criteria: - 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, Exclusion Criteria: - Analgesic given up to 6 hours before the procedure, - With a congenital anomaly, • With any disease,

Study Design


Related Conditions & MeSH terms


Intervention

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

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 (12)

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

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

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/j — 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.2020.102 — 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 — 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 — View Citation

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 — View Citation

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

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

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. — View Citation

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.

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary PRETERM PAIN Neonatal Infant Pain Scale AT THE FIRST MINUTE OF VENIPUNCTURE
Primary MOTHER'S ANXIETY State-Trait Anxiety Scale FIVE MINUTES AFTER VENIPUNCTURE
Secondary HEART RATE Measured 3 times in total AT THE FIRST MINUTE OF VENIPUNCTURE
Secondary OXYGEN SATURATION Measured 3 times in total AT THE FIRST MINUTE OF VENIPUNCTURE
Secondary CRYING TIME measured with a stopwatch METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED
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