CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Skin To Skin +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06077409
NCT06077409N/ACompleted

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

Istanbul University - Cerrahpasa·interventional·Posted Oct 11, 2023·Updated Oct 11, 2023

In Brief

A clinical study evaluating Skin To Skin and Gentle Human Touch for Venipuncture and 2 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenipuncture, Pain, Touch
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 11, 2023
Enrollment StartFeb 17, 2022
Primary CompletionJul 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.7 years ago

Interventions

Skin To Skinother

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.

Gentle Human Touchbehavioral

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.