An interventional study of Skin To Skin and Gentle Human Touch in Venipuncture, Pain and Touch, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 32 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Prevention
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.
Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.
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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
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
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.
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.
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.
Preterm Pain
Neonatal İnfant Pain Scale
Time frame: 5 minutes. At the first mınute of venipuncture Scores will be given between 0-7 points.
Preterm Crying
Stopwatch
Time frame: 5 mınutes. During blood collection, the stopwatch will turn on when the baby starts crying and turn off when the baby stops crying.
Heart Rate
Measured 3 times in total
Time frame: 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
Measured 3 times in total
Time frame: 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
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Istanbul University - Cerrahpasa