Pain Clinical Trial
Official title:
The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
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 |
Verified date | February 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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, |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital | Istanbul | Üsküdar |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
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* Note: There are 12 references in all — Click here to view all references
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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