Effect of Massage and Foot Reflexology on Newborns' Sleep

NCT06201962 | Completed

• 1 other identifier: ABozokU
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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 was carried out on 108 preterm newborns with gestational weeks between 30-37, hospitalized in the neonatal intensive care unit of a city hospital. The researcher was applied massage (n:36) and foot reflexology (n:36) to the newborns for 15 minutes, twice a day for 2 days. No intervention other than routine clinical practices was applied to the control group (n:36). The 24-hour sleep of the newborns included in the study was monitored with a sleep-wakefulness measuring device before the application and on the day the naps end, and was recorded in the newborn follow-up form. Statistical analysis was performed using percentages, means, median, variance and Kruskal Wallis, Wilcoxon tests test.

Conditions

Preterm Infants; Sleep

Keywords

Preterm Infants; Sleep Wake Cycle; Massage; Foot Reflexology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Massage

EXPERIMENTAL

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

Foot Reflexology

EXPERIMENTAL

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

Control

EXPERIMENTAL

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

Interventions

Massage OTHER

Massage applications will be performed for 15 minutes every morning and evening for two days.

Massage

Foot Reflexology OTHER

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

Control OTHER

Newborns will receive routine medical treatment and nursing care and will not undergo any procedures.

Control

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Gender Eligibility Details: Preterm babies will be included in each group in equal numbers as boys and girls.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Bozok University

Yozgat, Turkey (Türkiye)

Location

Related Publications (7)

• de Groot ER, Knoop MS, van den Hoogen A, Wang X, Long X, Pillen S, Benders M, Dudink J. The value of cardiorespiratory parameters for sleep state classification in preterm infants: A systematic review. Sleep Med Rev. 2021 Aug;58:101462. doi: 10.1016/j.smrv.2021.101462. Epub 2021 Mar 14.

  PMID: 33826975 BACKGROUND

• Sentner T, Wang X, de Groot ER, van Schaijk L, Tataranno ML, Vijlbrief DC, Benders MJNL, Bartels R, Dudink J. The Sleep Well Baby project: an automated real-time sleep-wake state prediction algorithm in preterm infants. Sleep. 2022 Oct 10;45(10):zsac143. doi: 10.1093/sleep/zsac143.

  PMID: 35749799 BACKGROUND

• Firmino C, Rodrigues M, Franco S, Ferreira J, Simoes AR, Castro C, Fernandes JB. Nursing Interventions That Promote Sleep in Preterm Newborns in the Neonatal Intensive Care Units: An Integrative Review. Int J Environ Res Public Health. 2022 Sep 2;19(17):10953. doi: 10.3390/ijerph191710953.

  PMID: 36078666 BACKGROUND

• Park J. Sleep Promotion for Preterm Infants in the NICU. Nurs Womens Health. 2020 Feb;24(1):24-35. doi: 10.1016/j.nwh.2019.11.004. Epub 2020 Feb 19.

  PMID: 32083554 BACKGROUND

• Uchitel J, Vanhatalo S, Austin T. Early development of sleep and brain functional connectivity in term-born and preterm infants. Pediatr Res. 2022 Mar;91(4):771-786. doi: 10.1038/s41390-021-01497-4. Epub 2021 Apr 15.

  PMID: 33859364 BACKGROUND

• Jazayeri Z, Sajadi M, Dalvand H, Zolfaghari M. Comparison of the effect of foot reflexology and body massage on physiological indicators and bilirubin levels in neonates under phototherapy. Complement Ther Med. 2021 Jun;59:102684. doi: 10.1016/j.ctim.2021.102684. Epub 2021 Feb 17.

  PMID: 33609634 BACKGROUND

• Baniasadi H, Hosseini SS, Abdollahyar A, Sheikhbardsiri H. Effect of massage on behavioural responses of preterm infants in an educational hospital in Iran. J Reprod Infant Psychol. 2019 Jul;37(3):302-310. doi: 10.1080/02646838.2019.1578866. Epub 2019 Feb 21.

  PMID: 30786750 BACKGROUND

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ayşe Belpınar, Phd

  Bozok University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Because of the nature of the intervention, double-blinding was not possible in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study used a randomized controlled trial. A parallel trial design was used describing two different experimental groups (Massage and Foot Reflexology) and a control group

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: September 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: August 2, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)