Effect of Massage and Foot Reflexology on Newborns' Sleep

January 2, 2024 updated by: Ayşe Belpınar, Bozok University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Kayseri̇/kocasi̇nan
      • Kayseri, Kayseri̇/kocasi̇nan, Turkey, 38080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage
Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information will be given about the massage to be performed on the newborn. Before applying massage to premature babies, their 24-hour sleep duration will be evaluated with an actigraphy device. Starting from the face with gentle touches, massage will be applied to the baby's forehead, around the eyes and cheeks with 2 fingers, without pressing too much. Then, the chest area will be massaged with circular movements from right to left, and then the upper and lower extremities will be massaged. Finally, the massage will be completed by turning the baby face down and applying gentle pressure to the back area. Massage applications will be performed for 15 minutes every morning and evening for two days. On the morning of the second day, an actigraphy device will be attached to the premature babies' ankles and their 24-hour sleep will be re-evaluated.
Other: Massage
Massage applications will be performed for 15 minutes every morning and evening for two days.
Experimental: Foot Reflexology
Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information will be given about the foot reflexology to be performed on the newborn. In addition to daily routine nursing care and monitoring for premature babies, before applying foot reflexology, the actigraphy device will be attached to the babies' ankles and their 24-hour sleep duration will be evaluated. 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. Foot reflexology will be performed for 15 minutes every morning and evening for two days. On the morning of the second day, an actigraphy device will be attached to the premature babies' ankles and their 24-hour sleep will be re-evaluated.
Other: 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.
Experimental: Control
Newborns will receive routine medical treatment and nursing care and will not undergo any procedures. Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information about the study will be given. Premature babies will have their 24-hour sleep recorded with actigraphy 1 day in advance. Then, the nursing care that premature babies receive in their daily routine will be given for two days. On the morning of the second day, an actigraphy device will be attached to the left foot of the premature babies and their 24-hour sleep on the second day will be recorded.
Other: Control
Newborns will receive routine medical treatment and nursing care and will not undergo any procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sleep
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozok University

Investigators

  • Study Director: Emriye Hilal Yayan, Phd, İnönü University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ayşe Belpınar, BozokU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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