Effect of Massage and Foot Reflexology on Newborns' Sleep

Sleep Clinical Trial

Official title:

Effect of Massage and Foot Reflexology on Newborns' Sleep

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201962
• Other study ID #: Ayse Belpinar, BozokU
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: January 2024
• Source: Bozok University
• Contact: Ayse Belpinar, Msc
• Phone: 03542111190
• Email: pnrayse635[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: Newborns undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life for various reasons. Leaving the warm, dark, quiet, calm, fluid-filled mother's womb of newborns whose systems are not yet mature and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake pattern required for growth-development and neurodevelopment. It is intensive for the development of newborns' neurosensory systems. They have sleep requirements. It is known that the brain activity of newborns during the intrauterine period is similar to REM (Rapid Eye Movement) sleep activity, they sleep more than adults, and they spend most of their sleep in the REM sleep period. For this reason, our research will be conducted to examine the effects of massage and foot reflexology applied to preterm newborns on sleep.

Design and Methods: This randomized experimental study will be carried out on 105 preterm newborns with gestational weeks between 30-37, hospitalized in the neonatal intensive care unit of a city hospital. The researcher will apply massage (n:35) and foot reflexology (n:35) to the newborns for 15 minutes, twice a day for 2 days. No intervention other than routine clinical practices will be applied to the control group (n:35). The 24-hour sleep of the newborns included in the study will be monitored with a sleep-wakefulness measuring device before the application and on the day the naps end, and will be recorded in the newborn follow-up form. Statistical analysis will be performed using percentages, means and ANOVA test.

Description:

Sleep is very important for human life and developmentally involves both physiological and mental processes. Sleep is considered not only as a state of rest, but also as a state of intense brain development in which neurotransmitters specific to each sleep stage affect brain maturation . Newborns sleep an average of 16-20 hours a day, spending most of their sleep in the REM (Rapid Eye Movement Phase) sleep period. For this reason, sleep quality in the neonatal period directly affects healthy growth and development. Newborns, who leave the warm, dark, quiet, calm, amniotic fluid-filled mother's womb at birth, undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life due to various reasons .

Babies who leave the intrauterine period early are admitted to technologically equipped neonatal intensive care units. In the neonatal intensive care unit, they are exposed to many stressful stimuli and environmental factors. Premature babies are exposed to painful invasive procedures in the neonatal intensive care unit, negative environmental conditions such as frequent feeding, exposure to high-frequency sounds and constant light negatively affect their sleep-wake cycles.

There are studies in the literature to determine the sleep and wakefulness status of premature babies and the factors affecting them. There are studies examining massage, position and music practices applied to preterm babies. It was observed that the number of babies sleeping was higher in the measurements made after massage therapy in premature babies who received massage and premature babies who did not. Additionally, in his systematic review of massage practice; It has been revealed that it increases mother-baby interaction and positively affects sleep conditions by reducing stress levels and crying .

Today, the use of complementary and alternative medicine treatments is increasing in healthcare systems all over the world. Nurses can use these ways, along with regular treatments, to improve health. In this context, foot reflexology, one of the six most commonly used treatments in complementary medicine, is effective not only in the treatment of diseases but also in protecting health. Reflexology is defined as the science that stimulates the ends of sensory nerves connected to receptors and points related to the internal organs of the body using different degrees of pressure, such as massage and touch. By applying the compression technique to the reflection point of each organ using reflexology, the blockage in the energy flow path is removed and as a result, the energy flows in the movement channels. It has been stated that foot reflexology can improve the physiological index and reduce O2 saturation, heart rate, and inspire relaxation in newborns . There are studies examining the effects of invasive procedures on pain, comfort and physiological parameters .

Developing individualized supportive interventions that ensure deep sleep and wakefulness is important for the quality of care provided to preterm infants. For this reason, it is important to reduce the negativities caused by neonatal intensive care units, improve care, reduce pain caused by invasive procedures and the environment, and ensure the sleep quality and order of premature babies.

There are studies in the literature about the effects of massage and foot reflexology on pain, comfort and vital signs in preterm babies, but no study has been found comparing these methods and examining their effects on sleep. In the literature review, while there are studies in which parents subjectively evaluate children's sleep, no other studies were found in which premature babies' sleep is measured objectively. Therefore, it will be carried out to examine the effects of massage and foot reflexology applied to premature babies on sleep.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• Those born between 30-37 weeks of gestation and hospitalized in the Neonatal Intensive Care Unit

• Those who have a healthy skin structure (no acne, urticaria, eczema or any allergic problems)

• Birth weight of 1500 g and above,

• Do not have a medical condition (surgical intervention, mass, umbilical catheter, etc.) that contraindicates area massage.

• Those whose vital signs are stable

Exclusion Criteria:

• Those whose vital signs are stable

• Those with foot anomalies or those who underwent outpatient surgery

• Those dependent on high-frequency mechanical ventilation

• Those receiving sedative treatment

• Those with hyperbilirubinemia

• Babies with hypoglycemia or hyperglycemia

• Those with genetic and congenital anomalies

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants
• Sleep

Intervention

Other:
• Massage
Massage applications will be performed for 15 minutes every morning and evening for two days.
• Foot Reflexology
In the reflexology group, the researcher will hold the baby's foot with his left hand and gently massage each foot with the thumb of his right hand for 15 minutes.
• Control
Newborns will receive routine medical treatment and nursing care and will not undergo any procedures.

Locations

Country	Name	City	State
Turkey	Kayseri City Hospital	Kayseri	Kayseri?/kocasi?nan

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sleep	The researcher will monitor the newborn babies' sleep times with a sleep-wake measurement device for 24 hours and record them in the Newborn Follow-up Form.	24 hours